RxNews® - New Generics

Provides details of recent and upcoming drug patent changes, as well as new generic product releases.

Lovaza® (omega-3-acid ethyl esters) – First-Time Generic

April 8, 2014 -- Teva Pharmaceuticals announced the FDA approval of a generic version of GlaxoSmithKline’s Lovaza (omega-3-acid ethyl esters) 1 gm capsules.More..
Mepron® (atovaquone) – First-Time Generic

March 18, 2014 -- The FDA approved AB-rated generic versions of GlaxoSmithKline’s Mepron (atovaquone) 750 mg/5 mL oral suspension.More..
Evista® (raloxifene) – First-Time Generic

March 4, 2014 -- Teva announced the FDA approval of an AB-rated generic version of Eli Lilly’s Evista (raloxifene) 60 mg tablets.More..
Lodosyn® (carbidopa) – First-Time Generic

March 12, 2014 -- Amerigen Pharmaceuticals announced the FDA approval of an AB-rated generic version of Valeant’s Lodosyn (carbidopa) 25 mg tablets.More..
Cipro® (ciprofloxacin) Oral Suspension – First-Time Generic

March 6, 2014 -- Lupin announced the FDA approval of AB-rated generic versions of Bayer’s Cipro (ciprofloxacin) 250 mg/5 mL and 500 mg/5 mL oral suspension formulations.More..
Mycobutin® (rifabutin) – First-Time Generic

February 26, 2014 -- Lupin announced the FDA approval of an AB-rated generic version of Pharmacia and Upjohn Company’s Mycobutin (rifabutin) 150 mg capsules.More..
Micardis® HCT (telmisartan/hydrochlorothiazide) – First-Time Generic

February 25, 2014 -- The FDA approved AB-rated generic versions of Boehringer Ingelheim’s Micardis HCT [telmisartan/hydrochlorothiazide (HCTZ)] 80 mg/25 mg, 80 mg/12.5 mg, and 40 mg/12.5 mg tablets.More..
Avelox® (moxifloxacin) – First-time Generic

February 18, 2014 -- The FDA approved an AB-rated generic version of Bayer’s Avelox (moxifloxacin) 400 mg tablets.More..
Boniva® (ibandronate) Injection – First-Time Generic

February 14, 2014 -- The FDA approved an AP-rated generic version of Roche’s Boniva (ibandronate) injection.More..
Hectorol® (doxercalciferol) – First-time Generic

February 5, 2013 -- Sandoz announced the launch of AP-rated doxercalciferol injection vials, the first generic version of Genzyme's Hectorol (doxercalciferol).More..
Avinza® (morphine sulfate) – First-Time Generic

February 4, 2014 -- Actavis launched AB-rated generic versions of King Pharmaceuticals’ Avinza (morphine sulfate) extended release (ER) capsules.More..
Rapamune® (sirolimus) – First-Time Generic

January 20, 2014 -- The FDA approved an AB-rated generic of Pfizer’s Rapamune (sirolimus) 0.5 mg tablets. Generics were launched immediately.More..
Vanos® (fluocinonide) – First-Time Generic

January 14, 2014 -- Perrigo announced the FDA approval of an AB-rated generic version of Medicis’ Vanos (fluocinonide) 0.1% cream.More..
Nexium® IV (esomeprazole sodium) – First-Time Generic

January 13, 2014 -- Sun Pharma Global launched esomeprazole 20 mg and 40 mg intravenous (IV) injections, AP-rated generic versions of AstraZeneca’s Nexium IV (esomeprazole).More..
Micardis® (telmisartan) – First-Time Generic

January 8, 2013 -- The FDA approved AB-rated generic versions of Boehringer Ingelheim’s Micardis (telmisartan) tablets.More..
Twynsta® (amlodipine/telmisartan) – First-Time Generic

January 8, 2014 -- The FDA approved AB-rated generic versions of Boehringer Ingelheim’s Twynsta (amlodipine/telmisartan) 5 mg/40 mg, 10 mg/40 mg, 5 mg/80 mg, and 10 mg/80 mg tablets.More..
Myfortic® (mycophenolic acid) – First-time Generic

January 8, 2014 -- Mylan launched generic versions of Novartis’ Myfortic (mycophenolic acid) 180 mg and 360 mg delayed release tablets.More..
Epivir-HBV® (lamivudine) – First-Time Generic

January 2, 2014 -- Apotex launched lamivudine 100 mg tablets, an AB-rated generic version of GlaxoSmithKline’s Epivir-HBV (lamivudine).More..
Trizivir® (abacavir/lamivudine/zidovudine) – First-Time Generic

December 18, 2013 -- Lupin announced the launch of an AB-rated generic version of Viiv Healthcare’s Trizivir (abacavir/lamivudine/zidovudine) tablets..More..
Cymbalta® (duloxetine) – First-Time Generic

December 11, 2013 -- The FDA announced the approval of AB-rated generic versions of Eli Lilly’s Cymbalta (duloxetine) 20 mg, 30 mg, and 60 mg delayed-release (DR) capsules..  More..
Focalin XR® (dexmethylphenidate HCl) – First-Time Generic

November 18, 2013 -- The FDA approved AB-rated generic versions of Novartis’ Focalin XR (dexmethylphenidate HCl) 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg extended-release (ER) capsules.More..
Aciphex® (rabeprazole) – First-Time Generic

November 8, 2013 -- The FDA announced the approval of several AB-rated generic versions of Eisai’s Aciphex (rabeprazole) 20 mg delayed-release (DR) tablets. More..
Detrol® LA (tolterodine) – First-Time Generic

October 31, 2013 -- The FDA approved an AB-rated generic version of Pfizer’s Detrol LA (tolterodine) 2 mg and 4 mg extended-release capsules. Mylan is expected to launch this generic in the first quarter of 2014.More..
Solaraze® (diclofenac) – First-Time Generic

October 30, 2013 -- Impax and Tolmar announced the FDA approval of an AT-rated generic version of Fougera’s Solaraze (diclofenac) 3% topical gel.More..
TOBI® (tobramycin inhalation solution) – First-Time Generic

October 14, 2013 -- Teva announced the FDA approval of an AN-rated generic version of Novartis’ TOBI (tobramycin inhalation solution).More..
Kapvay® (clonidine) – First-Time Generic

October 7, 2013 -- Par launched an AB-rated generic version of Shionogi’s Kapvay (clonidine) 0.1 mg extended-release (ER) tablets.More..
Zymaxid® (gatifloxacin) – First-Time Generic

October 1, 2013 -- Lupin launched an AT-rated generic version of Allergan’s Zymaxid (gatifloxacin) 0.5% ophthalmic solution.More..
Locoid Lipocream® (hydrocortisone butyrate) – First-Time Generic

September 30, 2013 -- Glenmark Generics announced the FDA approval of an AB-rated generic version of Onset Dermatologics’ Locoid Lipocream (hydrocortisone butyrate) 0.1% cream. More..
Zemplar® (paricalcitol) – First-time Generic

September 27, 2013 -- Teva received FDA approval for an AB-rated generic of Abbvie’s Zemplar (paricalcitol) capsules in the United States.More..
Niaspan® (niacin extended-release) – First-time Generic

September 20, 2013 -- Teva announced the launch of an AB-rated generic of Abbvie’s Niaspan [niacin extended-release (ER)] in the United States.More..
Vidaza® (azacitidine) – First-time Generic

September 17, 2013 -- Dr. Reddy’s Laboratories announced the FDA approval of azacitidine for injection (100 mg/vial), an AP-rated generic version of Celgene’s Vidaza® (azacitidine).More..
Lidoderm® (lidocaine patch) – First-time Generic

September 16, 2013 -- Actavis announced the launch of an AB-rated generic version of Endo’s Lidoderm® (lidocaine patch 5%).More..
Xeloda® (capecitabine) – First-time Generic

September 16, 2013 -- The FDA announced the approval of Teva’s AB-rated generic version of Genentech’s Xeloda (capecitabine) 150 mg and 500 mg tablets.More..
Prandin® (repaglinide) 0.5 mg – First-Time Generic

September 13, 2013 -- Perrigo and Mylan launched AB-rated generic versions of Novo Nordisk’s Prandin (repaglinide) 0.5 mg tablets.More..
Hepsera® (adefovir) – First-Time Generic

September 10, 2013 -- Sigmapharm announced the launch of an AB-rated generic version of Gilead’s Hepsera (adefovir) tablets.More..
Prevpac® (lansoprazole/amoxicillin/clarithromycin) – First-Time Generic

September 9, 2013 -- Teva announced the launch of an AB-rated generic version of Takeda’s Prevpac (lansoprazole/amoxicillin/clarithromycin) kit.More..
Kadian® (morphine sulfate) – First-Time Generic

August 29, 2013 -- Upsher-Smith Laboratories announced the upcoming September 4, 2013 launch of morphine sulfate 10 mg extended-release (ER) capsules, an AB-1 rated generic version of Watson’s Kadian (morphine sulfate) 10 mg ER capsules.More..
Campral® (acamprosate) – First-Time Generic

August 16, 2013 -- Glenmark Generics announced the FDA approval of acamprosate delayed-release (DR) tablets, an AB-rated generic version of Forest Laboratories’ Campral (acamprosate).More..
Temodar® (temozolomide) – First-Time Generic

August 12, 2013 -- Teva and Perrigo announced the launch of AB-rated generic versions of Merck’s Temodar® (temozolomide) 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg capsules..More..
Aricept® (donepezil) 23 mg – First-Time Generic

July 27, 2013 -- Dr. Reddy’s Laboratories announced the launch of donepezil 23 mg tablets, a generic version of Eisai’s Aricept (donepezil) 23 mg.More..
Soriatane® (acitretin) – First-Time Generic

July 19, 2013 -- Teva launched AB-rated generic versions of Stiefel’s Soriatane (acitretin) 10 mg, 17.5 mg, and 25 mg capsules.More..
Lamictal® ODT (lamotrigine) – First-Time Generic [CORRECTION]

July 15, 2013 -- The FDA approved Watson’s AB-rated generic versions of GlaxoSmithKline’s Lamictal ODT (lamotrigine) 25 mg, 50 mg, 100 mg, and 200 mg oral disintegrating tablets (ODTs).More..
Trilipix® (fenofibric acid) – First-Time Generic

July 15, 2013 -- Mylan announced the launch of AB-rated generic versions of Abbot’s Trilipix (fenofibric acid) 45 mg and 135 mg delayed-release capsules. Global Pharmaceuticals also launched an authorized generic of Trilipix.More..
Dacogen® (decitabine) – First-Time Generic

July 12, 2013 -- Dr. Reddy’s Laboratories announced the generic launch of decitabine 50 mg injection. Decitabine is AP-rated to Eisai’s Dacogen (decitabine).More..
Prandin® (repaglinide) – First-Time Generic

July 12, 2013 -- Sun Pharma announced the launch of generic versions of Novo Nordisk’s Prandin (repaglinide) 1 mg and 2 mg tablets.More..
Metrogel® (metronidazole) 1% Gel – First-Time Generic

July 2, 2013 -- Sandoz announced the launch of a generic version of Metrogel (metronidazole) 1% gel.More..
Rilutek® (riluzole) – First-Time Generics

June 19, 2013 -- Apotex, Glenmark Generics, and Sun Pharma launched generic versions of Rilutek (riluzole) tablets.More..
Vfend® (voriconazole) Oral Suspension – First-time Generics

June 3, 2013 -- The FDA approved Mylan's voriconazole (200 mg/5 mL) oral suspension, an AB-rated generic version of Pfizer's Vfend (voriconazole) oral suspension.More..

Zomig® (zolmitriptan) and Zomig-ZMT® (zolmitriptan) – First-time Generics

May 14, 2013 -- The FDA approved AB-rated generic versions of AstraZeneca and Impax Laboratories’ Zomig (zolmitriptan) tablets and Zomig-ZMT (zolmitriptan) oral disintegrating tablets (ODTs). Generics were launched immediately by multiple manufacturers.More..

Atacand® (candesartan) – First-time Generic

May 10, 2013 -- The FDA approved Sandoz's AB-rated generic version of AstraZeneca's Atacand (candesartan) tablets.  More..

Zovirax® (acyclovir) – First-time Generic

April 5, 2013 -- Actavis and Mylan launched generic acyclovir 5% ointment. Generic acyclovir ointment is AB-rated to Valeant’s Zovirax (acyclovir) ointment.  More..

Reclast® (zoledronic acid) – First-time Generic

April 4, 2013 -- Dr.Reddy announced the launch of an AP-rated generic version of Novartis’ Reclast (zoledronic acid) injection. Emcure Pharmaceuticals also received FDA approval for an AP-rated generic version of Reclast. More..

Luvox CR® (fluvoxamine) capsules - First-time Generic

March 14, 2013 -- Par Pharmaceutical announced the FDA approval of an AB-rated generic version of Jazz Pharmaceuticals' Luvox CR (fluvoxamine) extended-release (ER) capsules. Par launched fluvoxamine 100 mg and 150 mg ER capsules immediately.  More..

Zometa® (zoledronic acid) – First-time Generic

March 5, 2013 -- Dr. Reddy and Sagent Pharmaceuticals announced the FDA approval for an AP-rated generic version of Novartis’ Zometa (zoledronic acid) injection. Dr. Reddy and Sagent Pharmaceuticals launched zoledronic acid injection as 4 mg/5mL single use vials immediately. More..

Suboxone® (buprenorphine/naloxone) – First-time Generic

February 26, 2013 -- Actavis and Amneal received FDA approval for buprenorphine/naloxone sublingual (SL) tablets, the AB-rated generic equivalents to Reckitt Benckiser Healthcare's Suboxone (buprenorphine/naloxone). More..

Sulfamylon® (mafenide acetate) – First-time Generic  

February 20, 2013 -- Par Pharmaceutical received FDA approval for an AB-rated generic version of Mylan’s Sulfamylon (mafenide acetate) for 5% topical solution. Par Pharmaceutical will launch mafenide acetate for 5% topical solution immediately. More...

Doxil® (doxorubicin hydrochloride liposome injection) – First-time Generic

February 4, 2013 -- Sun Pharma received FDA approval for an AB-rated generic version of Janssen’s Doxil (doxorubicin liposome injection). Sun Pharma plans to launch doxorubicin liposome injection as 20 mg and 50 mg vials in March 2013. More...

Olux®-E (clobetasol) – First-time Generic

February 1, 2013 -- Perrigo announced the launch of the first-time generic version of Stiefel Labs' Olux-E (clobetasol). Perrigo's clobetasol emulsion propionate 0.05% foam is AB2-rated to Olux-E. More...

Bactroban® (mupirocin cream) – First-time Generic

January 24, 2013 -- Glenmark Generics received FDA approval for an AB-rated generic version of GlaxoSmithKline’s Bactroban (mupirocin) 2% cream.  More...

First-time Generics: November 2012 - January 2013

A list of first-time generics approved from November 2012 through January 2013.  More...

Acetadote® (acetylcysteine) injection – First-time Generic

January 8, 2013 -- InnoPharma announced the FDA approval of an AP-rated generic version of Cumberland’s Acetadote (acetylcysteine) 20% solution for injection.  More...

Duetact® (pioglitazone/glimepiride) – First-time Generic

Januray 4, 2013 -- Sandoz received FDA approval to market the AB-rated generic version of Takeda’s Duetact (pioglitazone/glimepiride). Generic pioglitazone/glimepiride tablets were launched immediately.  More...

Dilantin® Infatabs (phenytoin) - First-time Generic

December 28, 2012 -- Mylan announced the FDA approval of an AB-rated generic version of Pfizer’s Dilantin Infatabs (phenytoin) 50 mg chewable tablets.  More...

Lysteda® (tranexamic acid) - First-time Generic

January 3, 2013 -- Watson announced the FDA approval of an AB-rated generic version of Ferring Pharmaceuticals' Lysteda (tranexamic acid) 650 mg.  More...

Propecia® (finasteride) – First-time Generic

January 2, 2013 -- Dr. Reddy announced the FDA approval of an AB-rated generic version of Merck’s Propecia (finasteride) 1 mg tablets. More...

Maxalt®/Maxalt-MLT® (rizatriptan)– First-time Generics

December 31, 2012 -- The FDA approved generic versions of Maxalt (rizatriptan) 5 mg and 10 mg tablets as well as Maxalt-MLT (rizatriptan) 5 mg and 10 mg orally disintegrating tablets (ODT). Generic rizatriptan tablets and rizatriptan ODT are AB-rated to Merck’s Maxalt and Maxalt-MLT (rizatriptan) products. More...

Grifulvin V® (griseofulvin) - First-time Generic

December 14, 2012 -- Sigmapharm announced the FDA approval of an AB-rated generic version of Valeant Pharmaceuticals’ Grifulvin V (griseofulvin microsize) 500 mg tablets. More...

Atacand HCT® (candesartan/hydrochlorothiazide) – First-time Generic

December 4, 2012 -- Apotex and Mylan launched AB-rated generics of AstraZeneca’s Atacand HCT [candesartan/hydrochlorothiazide (HCTZ)] tablets. As part of an agreement with AstraZeneca, Par launched an authorized generic version of Atacand HCT. More...

Tricor® (fenofibrate) – First-time Generic

November 20, 2012 -- Lupin Pharmaceuticals launched its fenofibrate tablets (48 mg and 145 mg) in the United States. Lupin’s fenofibrate tablets are the AB-rated generic equivalent of Abbott's Tricor (fenofibrate). Teva also launched authorized generic versions of Tricor tablets. More...

Revatio® (sildenafil) – First-time Generic

November 6, 2012 -- The FDA approved generic versions of Revatio (sildenafil) 20 mg tablets; these products were launched immediately. Generic sildenafil 20 mg tablets are AB-rated to Pfizer’s Revatio (sildenafil) 20 mg tablets. More...

Sanctura XR® (trospium extended-release) – First-time Generic

October 12, 2012 -- Watson launched an AB-rated generic of Allergan’s Sanctura XR (trospium extended-release) 60 mg capsules. More...

Evoxac® (cevimeline) – First-time Generic

October 9, 2012 -- Apotex and Ranbaxy launched AB-rated generics of Daiichi Sankyo’s Evoxac (cevimeline) 30 mg capsules. More...

First Time Generics: August 2012 - October 2012

A list of first-time generics approved from August 2012 to the beginning of October 2012. More...

Comtan® (entacapone) – First-time Generic

October 3, 2012 -- Wockhardt launched an authorized generic of Orion Pharma’s Comtan (entacapone) 200 mg tablets. The generic entacapone tablets are AB-rated to brand Comtan tablets. More...

Metadate CD® (methylphenidate) – First-time Generic

September 27, 2012 -- Teva announced the FDA approval of generic methylphenidate extended-release 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg capsules. Generic methylphenidate extended-release capsules are AB-rated to UCB’s Metadate CD (methylphenidate) capsules. More...

Diovan HCT® (valsartan/hydrochlorothiazide) – First-time Generic

September 21, 2012 -- Mylan announced the FDA approval of its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide (HCTZ), the AB-rated generic version of Novartis’ Diovan HCT (valsartan/HCTZ). More...

Lidoderm® (lidocaine) – First-time Generic

August 23, 2012 -- Watson announced that it has received final approval from the FDA on its abbreviated new drug application (ANDA) for lidocaine patch 5%, the AB-rated generic equivalent of Endo’s Lidoderm® (lidocaine patch 5%). More...

Alocril® (nedocromil) – First-time Generic

August 22, 2012 -- The FDA approved Akorn’s nedocromil ophthalmic solution 2%, the AT-rated generic equivalent of Allergan’s Alocril® (nedocromil). More...

Xopenex® (levalbuterol hydrochloride) – First-time Generic

August 20, 2012 -- Watson and Prasco announced that they have launched AN-rated authorized generics of Sunovion’s Xopenex (levalbuterol hydrochloride) 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL inhalation solution. More...

Actos® (pioglitazone) and Actoplus Met® (pioglitazone/metformin) – First-time Generics

August 17, 2012 -- The FDA approved Mylan’s Abbreviated New Drug Application (ANDA) for pioglitazone, the generic version of Takeda’s Actos (pioglitazone). Previously, Mylan also received FDA approval for the ANDA of pioglitazone/metformin, a generic version of Actoplus Met (pioglitazone/metformin). More...

First Time Generics - May 2012 - July 2012

View the most recent FDA approvals of  first time generics from May through July 2012. More...

Singulair® (montelukast) – First-time Generic

August 3, 2012 -- The FDA approved generic Singulair (montelukast) as tablets, chewable tablets and oral granules. AB-rated generic montelukast will be marketed by 10 different pharmaceutical companies. More...

Dovonex® (calcipotriene) – First-time Generic 

August 1, 2012, Sandoz launched generic calcipotriene cream 0.005%. Generic calcipotriene cream is AB-rated to Leo Pharma’s Dovonex (calcipotriene) cream. Generic calcipotriene cream is available as 60 gram and 120 gram tubes. More...

Plan B One-Step® (levonorgestrel) – First-time Generic

July 13, 2012 -- Watson Pharmaceuticals announced the FDA approval of its Abbreviated New Drug Application for Next Choice™ ONE DOSE (levonorgestrel), the generic equivalent to Teva Women's Health's Plan B One-Step® (levonorgestrel). More...

Arthrotec® (diclofenac sodium/misoprostol) – Generic Approval

July 11, 2012 -- Watson Pharmaceuticals announced the FDA approval of its Abbreviated New Drug Application for diclofenac sodium and misoprostol delayed-release tablets, the generic equivalent to G.D. Searle's Arthrotec®. More...

Duac® (clindamycin/benzoyl peroxide) – First-time Generic

June 27, 2012 -- Perrigo announced that it has received final approval from the FDA for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2%/5% topical gel, the AB-rated generic equivalent of Duac® (clindamycin/benzoyl peroxide). More...

Detrol® (tolterodine tartrate) – First-time Generic

June 25, 2012 -- Teva launched tolterodine tartrate tablets, an authorized generic version of Pharmacia & Upjohn’s Detrol® (tolterodine tartrate). More...

Ziagen® (abacavir) - First-time Generic

June 18, 2012 -- FDA approved Mylan's Abbreviated New Drug Application (ANDA) for abacavir 300 mg tablets, a generic version of Viiv Healthcare's Ziagen® (abacavir). More...

Plavix® (clopidogrel) – Generic Approval

May 17, 2012 -- The FDA approved generic versions of Bristol-Myers Squibb and Sanofi’s Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.. More...

 

Lescol® (fluvastatin) – First-time Generic

April 13, 2012 -- Mylan announced the FDA approval for its Abbreviated New Drug Application (ANDA) for fluvastatin 20 mg and 40 mg capsules, the first generic version of Novartis' Lescol (fluvastatin). The AB-rated fluvastatin capsules launched immediately. More...

Vancocin® (vancomycin) – First-time Generic

April 10, 2012 -- Watson announced the FDA approval for its Abbreviated New Drug Application (ANDA) for vancomycin 125 mg and 250 mg capsules, generic versions of ViroPharma’s Vancocin (vancomycin). In addition, Akorn and Alvogen also received FDA approval for vancomycin capsules. More...

Avapro® (irbesartan), Avalide® (irbesartan/hydrochlorothiazide) – First-time Generics

April 2, 2012 -- Teva Pharmaceutical Industries announced the commercial launch of both irbesartan and irbesartan/hydrochlorothiazide (HCTZ) tablets, the AB-rated generic versions of Sanofi- Aventis’ Avapro (irbesartan) and Avalide (irbesartan/HCTZ). More...

Provigil® (modafinil) – First-time Generic

March 30, 2012 -- Teva Pharmaceutical Industries launched the authorized generic version of Cephalon’s Provigil (modafinil). Provigil, a Schedule IV controlled substance will continue to be manufactured under the brand product's new drug application at the same facility where it is currently produced. More...

Cutivate™ (fluticasone propionate) – First-time Generic

March 27, 2012 -- The FDA approved an AB-rated generic version of PharmaDerm’s Cutivate (fluticasone propionate) 0.05% lotion. This product will be launched immediately. More...

Seroquel® (quetiapine) – First-time Generic

March 27, 2012 -- Teva and Dr. Reddy received FDA approval to manufacture AB-rated generics of AstraZeneca’s Seroquel (quetiapine) 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg tablets; the generics will launch immediately. More...

Boniva (ibandronate) – First-time Generic

March 19, 2012 -- The FDA approved the first generic versions of Genentech’s Boniva (ibandronate) 150 mg tablets, a once-monthly medicine for the treatment and prevention of osteoporosis in postmenopausal women. More...

Lexapro® (escitalopram) – First-time Generic

March 14, 2012 -- The FDA approved an AB-rated generic version of Forest Laboratories’ Lexapro (escitalopram) tablets. Teva Pharmaceutical Industries received FDA approval for escitalopram 5 mg, 10 mg and 20 mg tablets; these products will launch immediately. More...

Geodon® (ziprasidone) – First-time Generic

March 2, 2012 -- The FDA approved AB-rated generic versions of Pfizer’s Geodon (ziprasidone) capsules. Dr. Reddy’s, Lupin, and Apotex received FDA approval for ziprasidone 20 mg, 40mg, 60 mg, and 80 mg capsules; these generic products were launched immediately. Greenstone also launched an authorized generic version of Geodon. More...

Prometrium® (progesterone) – First-time Generic

March 2, 2012 -- Teva and Watson launched generic progesterone 100 mg and 200 mg capsules. Generic progesterone capsules are AB-rated to Abbott’s Prometrium (progesterone) capsules.(progesterone) capsules. More...

Teveten® (eprosartan) – First-time Generic

December 27, 2011 -- The FDA approved Mylan’s Abbreviated New Drug Application for eprosartan 400 mg and 600 mg tablets, the generic equivalent to Teveten (eprosartan). Mylan began distribution of the AB-rated eprosartan tablets immediately. More...

First-Time Generics Summary Table – September and October 2011

Provides a summary table of first-time generic launches within the past two months. More...

Epivir® (lamivudine) – First-time Generic  

Decenber 2, 2011 -- The FDA approved Aurobindo and Apotex’s Abbreviated New Drug Applications for lamivudine 150 mg and 300 mg tablets, the generic equivalent of Epivir® (lamivudine). Aurobindo and Apotex began distribution of the AB-rated products. More...

Lipitor® (atorvastatin) – First-time Generic Update

Late afternoon on November 30, 2011 -- The FDA approved Ranbaxy’s application to market generic versions of Pfizer’s Lipitor (atorvastatin) tablets in 10 mg, 20 mg, 40 mg, and 80 mg strengths. Generic atorvastatin is AB-rated to Lipitor. More...

Lipitor® (atorvastatin) and Caduet® (atorvastatin/amlodipine) – First-time Generics

November 30, 2011 -- Watson immediately launched authorized generic versions of Pfizer’s Lipitor (atorvastatin) tablets in all available strengths (10 mg, 20 mg, 40 mg, and 80 mg). More...

Kadian® (morphine sulfate ER) – First-time Generic

November 10, 2011 -- Watson Pharmaceuticals announced the FDA approval for its Abbreviated New Drug Application for morphine sulfate ER capsules, the generic equivalent of Kadian® (morphine sulfate ER). Watson began shipping the AB-rated product immediately. In addition, Actavis also began shipping morphine sulfate ER capsules, an authorized generic of Kadian. More...

Xyzal® (levocetirizine) solution – First-time generic

November 7, 2011 -- Perrigo Company and Synthon Pharmaceuticals launched the first generic version of Xyzal (levocetirizine solution), 2.5 mg/5mL, immediately with a 180-day marketing exclusivity. More...

Zyprexa®, Zyprexa® Zydis®, Symbyax® – First-time generics

October 24, 2011 -- The FDA approved the first generic versions of Zyprexa (olanzapine) tablets, Zyprexa Zydis (olanzapine) orally disintegrating tablets, and Symbyax (olanzapine/fluoxetine) capsules to treat schizophrenia and bipolar disorder. More...

Malarone® (atovaquone/proguanil) – First-time generic

September 20, 2011 -- Glenmark Generics launched the first generic version of GlaxoSmithKline's Malarone (atovaquone/proguanil). Glenmark received 180-day marketing exclusivity for generic atovaquone/proguanil 250 mg/100 mg and 62.5 mg/25 mg tablets. More...

Keppra XR® (levetiracetam) – First-time generic

September 12, 2011 -- The FDA approved first-time generic versions of UCB’s Keppra XR (levetiracetam) extended-release (ER) tablets. Companies which received approval to market generic levetiracetam ER tablets include Watson, Apotex, Mutual, Par, Lupin, Teva, and Actavis. More...

Ionamin® (phentermine) – First-time generic

August 3, 2011 -- Lannett Company announced the FDA approval for its generic phentermine resin extended-release (ER) capsules. Phentermine resin ER 15 mg and 30 mg capsules are therapeutically equivalent to Ionamin (phentermine) capsules.More...

Zemplar® (paricalcitol) – First-time generic

August 3, 2011 -- The FDA approved Sandoz’ generic paricalcitol 0.002 mg/mL and 0.005 mg/mL injection, a bioequivalent version of Abbott’s Zemplar (paricalcitol) injection. Generic paricalcitol injection is AP-rated to Zemplar. More...

Uroxatral® (alfuzosin) - First-time generic

July 18, 2011 -- Apotex, Mylan, Sun Pharma, Teva, and Torrent received FDA approval of generic alfuzosin extended release (ER) tablets, bioequivalent versions of Sanofi-Aventis' Uroxatral (alfuzosin). Generic launches of these products will commence immediately with no marketing exclusivities. More...

Arixtra® (fondaprinux) - First-time generic

July 14, 2011 -- Dr. Reddy's Laboratories and Alchemia Limited announced the FDA approval of generic fondaparinux injection, a bioequivalent generic version of GlaxoSmithKline's Arixtra (fondaparinux). The approval covers fondaparinux 2.5 mg/ 0.5 mL, 5.0 mg/ 0.4 mL, 7.5 mg/ 0.6 mL, and 10 mg/ 0.8 mL doses of the drug in prefilled color-coded, single-dose syringes. Generic fondaparinux injections are AP-rated to Arixtra. More...

First-Time Generics Summary Table - March and April 2011

June 24, 2011, Provides a summary table of first-time generic launches within the past two months. More...

Levaquin® (levofloxacin) - First-time generic

June 20, 2011, The FDA approved the first generic versions of Ortho-McNeil-Janssen’s Levaquin (levofloxacin), an antibiotic approved to treat certain infections in adults ages 18 and older. Generic levofloxacin products are expected to launch immediately by multiple vendors. More...

Lybrel (levonorgestrel/ethinyl estradiol) - First-time generic

June 7, 2011, Watson received FDA approval for levonorgestrel/ethinyl estradiol tablets (0.09 mg/0.02 mg), the first generic equivalent to Pfizer’s Lybrel® tablets. The generic product is AB-rated to Lybrel. Watson expects to launch the product shortly. More...

Combivir (lamivudine/zidovudine) - First-time generic

May 25, 2011, The FDA approved Teva Pharmaceuticals’ generic version of ViiV Healthcare Company's Combivir (lamivudine/zidovudine) tablets. Per the terms of a settlement, shipment of generic Combivir is expected to begin during the fourth quarter 2011. More...

Xibrom® (bromfenac) – First-time generic

May 16, 2011, Mylan Pharmaceuticals launched bromfenac 0.09% ophthalmic solution, the first generic version of ISTA’s Xibrom (bromfenac). Mylan’s launch of bromfenac ophthalmic solution is based on a development and supply agreement with Coastal Pharmaceuticals. More...

Concerta (methylphenidate) – Authorized generic

May 2, 2011 -- Watson launched an authorized generic version of Concerta (methylphenidate) extended-release tablets, as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals (OMJPI). More...

Aromasin® (exemestane) - First-time generic approval

April 1, 2011 -- Roxane Laboratories gained FDA approval for the launch of exemestane 25 mg tablets, the first generic version of Aromasin. Exemestane is AB-rated and therapeutically equivalent to Aromasin. More...

Taxotere® (docetaxel) – First-time generic approval

March 9, 2011 -- Hospira announced FDA approval of docetaxel injection, the first generic version of Sanofi-Aventis's Taxotere® (docetaxel). Hospira expects to launch the product in March 2011. Generic docetaxel will be available as 20 mg, 80 mg, and 160 mg vials (10 mg/mL concentration). More...

Femhrt® (norethindrone acetate/ethinyl estradiol) – First time generic launch

February 17, 2011 -- Teva launched Jinteli™ (norethindrone acetate/ethinyl estradiol), the first generic version of Warner Chilcott’s Femhrt® tablets. Teva has 180-day marketing exclusivity of Jinteli. Watson Pharmaceuticals will launch an authorized generic. Jinteli is AB-rated and bioequivalent to Femhrt. More...

First-Time Generics Summary Table – December 2010 to February 2011

February 21, 2011 -- Provides a summary table of first-time generic launches within the past two months. More...

Vfend® (voriconazole) – First-time generic launch

February 15, 2011 -- Mylan Pharmaceuticals launched voriconazole 50 mg and 200 mg tablets, under a previously announced settlement and license agreement with Pfizer Inc. Voriconazole tablets are the AB-rated generic version of Pfizer's Vfend®. Greenstone has also launched an authorized generic of voriconazole tablets. Mylan was awarded 180 days of marketing exclusivity.  More...

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