RxNews® - New Generics

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

Transderm Scop® (scopolamine) — First-Time Generic

January 30, 2015 — The FDA approved Perrigo’s AB-rated generic version of Novartis’ Transderm Scop (scopolamine) transdermal system patch.More..
Lumigan® (bimatoprost) — First-Time Generic

February 23, 2015 — Lupin announced the FDA approval of its AT-rated generic to Allergan’s Lumigan (bimatoprost) 0.03% ophthalmic solution, for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.More..
Mirapex ER™ (pramipexole) — First-Time Generic

February 6, 2015 — Par Pharmaceuticals’ received FDA approval for AB-rated generic versions of Boehringer Ingelheim’s Mirapex ER (pramipexole) 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg extended-release (ER) tablets.More..
Namenda® (memantine) — First-Time Generic

January 30, 2015 — The FDA approved Mylan’s AB-rated generic version of Actavis’ Namenda (memantine) tablets, for the treatment of moderate to severe dementia of the Alzheimer’s type.More..
Nexium® (esomeprazole) — First-time Generic

January 26, 2015 — The FDA announced the first-time generic approval of AstraZeneca’s Nexium (esomeprazole) delayed-release (DR) capsules.More..
Norvir® (ritonavir) — First-Time Generic

January 15, 2015 — The FDA approved Roxane’s AB-rated generic version of AbbVie’s Norvir (ritonavir) tablets, for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.More..
Colcrys® (colchicine) — First-Time Generic

January 12, 2015 — Prasco announced the launch of an authorized generic version of Takeda’s Colcrys (colchicine) 0.6 mg tablets.More..
Zyvox® (linezolid) — First-Time Generic

January 5, 2015 — Teva announced the launch of its AP-rated generic to Pfizer’s Zyvox (linezolid) injection. More..
AndroGel® 1% (testosterone) — First-Time Generic

December 27, 2014 — Perrigo launched AB-rated generic versions of AbbVie’s AndroGel 1% (testosterone) topical gel, for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). More..
Vivelle-Dot® (estradiol transdermal system) — First-Time Generic

December 22, 2014 — Mylan announced the launch of its AB1-rated generic version of Novartis’ Vivelle-Dot (estradiol transdermal system), indicated for the treatment of moderate to severe vasomotor, vulvar, and vaginal atrophy symptoms due to menopause; hypoestrogenism due to hypogonadism, castration or primary ovarian failure; and prevention of postmenopausal osteoporosis. More..
Orapred ODT® (prednisolone sodium phosphate) — First-Time Generic

December 11, 2014 — Mylan announced the launch of its AB-rated generic version of Shionogi’s Orapred ODT (prednisolone sodium phosphate) indicated as an anti-inflammatory or immunosuppressive agent for certain diseases and conditions. More..
Robaxin® (methocarbamol) — First-Time Generic

December 11, 2014 — Mylan announced the launch of its AP-rated generic version of Hikma Maple’s Robaxin (methocarbamol) injection, as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.More..
Trezix™ (acetaminophen/caffeine/dihydrocodeine) — First-Time Generic

December 5, 2014 — Wraser announced the FDA approval of Trezix (acetaminophen/caffeine/dihydrocodeine bitartrate) for the relief of moderate to moderately severe pain. More..
Latisse® (bimatoprost) — First-Time Generic

December 1, 2014 — The FDA approved Apotex’s AT-rated generic version of Allergan’s Latisse (bimatoprost), to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.More..
Exforge HCT® (amlodipine/valsartan/hydrochlorothiazide) — First-Time Generic

December 1, 2014 — Teva announced the launch of its AB-rated generic to Novartis’ Exforge HCT [amlodipine/valsartan/hydrochlorothiazide (HCTZ)] for the treatment of hypertension to lower blood pressure.More..
Intuniv® (guanfacine) — First-Time Generic and New Warning

December 1, 2014 — Actavis announced the launch of its AB-rated generic to Shire’s Intuniv (guanfacine) extended-release (ER) tablets, for the treatment of attention deficit hyperactivity disorder as monotherapy and as adjunctive therapy to stimulant medications.More..
CellCept® (mycophenolate mofetil) — First-Time Generic

November 14, 2014 — Ascend Laboratories launched its AB-rated generic version of Genentech’s CellCept (mycophenolate mofetil) oral suspension, for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants.More..
Valcyte® (valganciclovir) — First-Time Generic

November 4, 2014 — The FDA approved Dr. Reddy’s and Endo’s AB-rated generic versions of Roche’s Valcyte (valganciclovir) 450 mg tablets.More..
Epivir® (lamivudine) — First-Time Generic

November 3, 2014 — The FDA approved Silarx’s generic version of ViiV Healthcare’s Epivir® (lamivudine) oral solution, for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection.More..
Stromectol® (ivermectin) — First-Time Generic

October 24, 2014 — The FDA approved Edenbridge’s AB-rated generic version of Merck’s Stromectol (ivermectin) tablets. More..
Patanase® (olopatadine) — First-Time Generic

October 8, 2014 — The FDA approved Apotex’s AB-rated generic version of Alcon’s Patanase (olopatadine) nasal spray, for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.More..
Exforge (amlodipine/valsartan) — First-Time Generic

September 30, 2014 — Par announced the launch of its AB-rated generic version of Novartis’ Exforge (amlodipine/valsartan) tablets, for the treatment of hypertension, to lower blood pressure in patients not adequately controlled on monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. More..
Cubicin® (daptomycin) — First-Time Generic

September 12, 2014 — The FDA approved Hospira’s AP-rated generic version of Cubist’s Cubicin (daptomycin) injection. More..
Protopic® (tacrolimus) — First-Time Generic

September 9, 2014 — The FDA approved Fougera’s AB-rated generic version of Astellas’ Protopic (tacrolimus) 0.03% and 0.1% topical ointment. More..
Vigamox® (moxifloxacin) — First-Time Generic

September 4, 2014 — The FDA approved Lupin’s AT-rated generic version of Alcon’s Vigamox (moxifloxacin hydrochloride) ophthalmic solution, for the treatment of bacterial conjunctivitis. More..
Fortesta® (testosterone) — First-Time Generic

September 2, 2014 — Qualitest announced the launch of the AB-rated generic to Endo’s Fortesta (testosterone) topical gel, for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). More..
Megace® ES (megestrol acetate) — First-Time Generic

August 28, 2014 — Twi announced the FDA approval of the AB-rated generic to Par’s Megace ES (megestrol acetate) 125 mg/ mL oral suspension, for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).More..
Baraclude® (entecavir) — First-Time Generic

August 26, 2014 — The FDA approved Teva’s AB-rated generic version of Baraclude (entecavir) tablets, for the treatment of chronic hepatitis B virus (HBV) infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. More..
Moxatag® (amoxicillin extended-release) — First-Time Generic

August 25, 2014 — Fera announced the authorized generic launch of Pragma’s Moxatag (amoxicillin extended-release) 775 mg tablets, for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older. More..
Halflytely® and Bisacodyl Tablet Bowel Prep Kit (PEG-3350/sodium chloride/sodium bicarbonate/potassium chloride; bisacodyl) — First-Time Generic

August 20, 2014 — The FDA approved Novel Lab’s AA-rated generic version of Braintree’s Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350/sodium chloride/sodium bicarbonate/potassium chloride; bisacodyl), for cleansing of the colon as a preparation for colonoscopy in adults. More..
Metozolv® ODT (metoclopramide) — First-Time Generic

August 15, 2014 — The FDA approved Novel Labs’ generic version of Salix’s Metozolv ODT (metoclopramide) orally disintegrating tablets.More..
Targretin® (bexarotene) — First-Time Generic

August 12, 2014 — The FDA approved Banner’s AB-rated generic version of Valeant’s Targretin (bexarotene) capsules, for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy. More..
Diovan® (valsartan) — First-Time Generic

June 27, 2014 — Ohm Laboratories' announced the FDA approval of AB-rated generic versions of Novartis’ Diovan (valsartan) 40 mg, 80 mg, 160 mg and 320 mg tablets. More..
Tarceva® (erlotinib) — First-Time Generic

June 11, 2014 — The FDA approved Mylan’s AB-rated generic version of Genentech’s Tarceva (erlotinib) tablets. More..
Testim® (testosterone) — First-Time Generic

June 11, 2014 — Auxilium announced the authorized generic launch of its Testim (testosterone) topical gel, for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism.  More..
Actonel® (risedronate sodium) — First-Time Generic

June 11, 2014 — Mylan, Apotex, and Actavis announced the launch of their AB-rated versions of Actavis’ (formerly Warner Chilcott) Actonel (risedronate sodium) 150 mg tablets, for the treatment and prevention of postmenopausal osteoporosis in women.  More..
Oxsoralen-Ultra® (methoxsalen) — First-time Generic

June 6, 2014 — Strides Arcolab announced the FDA approval of methoxsalen 10 mg soft gelatin capsules, an AB-rated generic of Valeant’s Oxsoralen-Ultra.  More..
Celebrex® (celecoxib) — First-Time Generic

May 30, 2014 — The FDA approved generic versions of Pfizer’s Celebrex (celecoxib) capsules, indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, ankylosing spondylitis, acute pain, and primary dysmenorrhea.  More..
Pennsaid® (diclofenac sodium) — First-Time Generic

May 28, 2014 — Apotex launched its generic version of Mallinckrodt’s Pennsaid® (diclofenac sodium) 1.5% topical solution, for the treatment of signs and symptoms of osteoarthritis of the knee(s).  More..
Rhinocort® Aqua (budesonide) — First-Time Generic

May 13, 2014 — Apotex announced the FDA approval of the AB-rated generic Rhinocort® Aqua (budesonide) nasal spray for the treatment of seasonal or perennial allergic rhinitis in adults and children ≥ 6 years of age.  More..
Exalgo® (hydromorphone HCl extended-release) — First-Time Generic

May 13, 2014 — Actavis Labs announced the FDA approval of AB-rated generic Exalgo [hydromorphone HCl extended-release (ER)] 8 mg, 12 mg, and 16 mg tablets.  More..
Astepro® (azelastine HCl) — First-Time Generic

May 12, 2014 — Perrigo announced the FDA generic approval of Meda’s Astepro (azelastine HCl) 0.15% nasal spray. This generic product was launched immediately.  More..
Renvela® (sevelamer carbonate) – First-Time Generic

April 16, 2014 -- Impax Laboratories announced the launch of authorized generic Renvela (sevelamer carbonate) 800 mg tablets, through Global Pharmaceuticals, Impax's generics division.  More..
Ortho Evra® (norelgestromin/ethinyl estradiol) – First-Time Generic

April 16, 2014 -- Mylan launched Xulane™ [norelgestromin/ethinyl estradiol (EE)] transdermal system (150/35 mcg per day), the generic version of Janssen's Ortho Evra (norelgestromin/EE).More..
Lunesta® (eszopiclone) – First-Time Generic

April 15, 2014 -- Teva and Mylan launched AB-rated generic versions of Sunovion Pharmaceuticals’ Lunesta (eszopiclone) 1 mg, 2 mg and 3 mg tablets.More..
Taclonex® (calcipotriene/betamethasone dipropionate) – First-Time Generic

April 1, 2014 -- Sandoz and Perrigo announced the launch of generic versions of Leo Pharma’s Taclonex (calcipotriene/betamethasone dipropionate) ointment.More..
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..

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