Generics/News
Allergan allows Amneal to market Alzheimer’s generic in 2025
Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement will enable Amneal to market generic versions of the drug from 2025 onwards.
Patent wins and losses for Teva
Teva Pharmaceutical Industries (Teva) – the world’s largest generics manufacturer – has reported a string of patent updates recently. In the first of Teva’s patent-related news, Forest Laboratories (Forest) – an American pharmaceutical company acquired by Actavis [1] – made a deal with Teva regarding a patent licensed to them and held by Mayne Pharma (an Australian specialty injectables company now owned by Pfizer).
Senators continue to raise concerns over price of Mylan’s EpiPen
On 30 August 2016, a group of 20 US senators led by democrat Elizabeth Warren sent a letter to Mylan’s CEO Heather Bresch expressing their ‘serious concerns’ about the company’s recent significant price hikes for the life-saving EpiPen Auto-Injector.
New generic versions of imatinib mesylate join the US market
Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early August 2016.
Launches, approvals and court cases for Sun Pharma
India’s largest drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) has launched ready-to-administer anticancer drug gemcitabine in six European countries and gained approval for a generic version of prescription cholesterol medicine Crestor, while also facing legal action from protesting employees.
FDA approves first generic nilutamide for treatment of prostate cancer
US generics producer ANI Pharmaceuticals (ANI) announced on 18 July 2016 that it had received US Food and Drug Administration (FDA) approval for its generic version of prostate cancer treatment Nilandron (nilutamide).
Glenmark gains approval for anti-epileptic generic
Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).
Dr Reddy’s to buy US generics from Teva
Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) announced on 11 June 2016 that it had made a deal with Teva Pharmaceutical Industries (Teva) and an affiliate of Allergan to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US.
Dr Reddy’s buys six OTC brands from Ducere Pharma
Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has entered the US branded consumer health products market by acquiring six over-the-counter (OTC) brands from US-based Ducere Pharma.
GSK appeals UK pay-for-delay fine
GlaxoSmithKline (GSK) is appealing a GBP 37.6 million fine from the UK’s Competition and Markets Authority (CMA) over pay-for-delay allegations.
FDA approves first generic rosuvastatin
The US Food and Drug Administration (FDA) announced on 29 April 2016 that it had approved the country’s first generic version of Astra Zeneca’s leading cholesterol drug Crestor (rosuvastatin).
Sun Pharma to buy 14 drug brands from Novartis in Japan
A wholly owned subsidiary of India’s Sun Pharmaceutical Industries (Sun Pharma) will acquire a portfolio of 14 established prescription brands from Novartis and Novartis Pharma in Japan for a sum of US$293 million. This will give Sun Pharma a strong foothold in Japan, the world’s second largest market after the US.
Apotex launches generic of nasal allergy treatment
On 24 March 2016, Canada-based Apotex announced that it had launched mometasone furoate monohydrate nasal spray in the US, the first generic version of Merck’s Nasonex. Mometasone furoate monohydrate is a once-daily anti-allergen indicated for the treatment of nasal congestion for adults and children over two years.
Teva launches generic acamprosate in US
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 22 March 2016 that it had launched a generic version of alcohol dependence treatment Campral (acamprosate).
FDA approves Teva’s Viagra generic
Israeli generics giant Teva Pharmaceuticals (Teva) has received US Food and Drug Administration (FDA) approval for its generic version of Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil), which is also called Revatio in the US.
Biocon gets first European generics approval
India-based biologicals specialist Biocon announced on 15 February 2016 that it had received its first European generics approval for a generic version of Astra Zeneca’s blockbuster anti-cholesterol drug Crestor (rosuvastatin).
Sun Pharma launches imatinib mesylate in the US
On 1 February 2016, Sun Pharmaceutical Industries (Sun Pharma) launched imatinib mesylate in the US, a generic version of Gleevec (imatinib mesylate) developed by Novartis. Sun Pharma received final approval for imatinib mesylate from the US Food and Drug Administration (FDA) in December 2015, and was granted 180 days of marketing exclusivity from the time of its launch.
UK paves way for generics of Eli Lilly’s Alimta
The UK High Court ruled on 12 February 2016 that Eli Lilly’s vitamin regimen patent for its lung cancer blockbuster Alimta (pemetrexed disodium) is not infringed by a generic version of the drug sold by Allergan’s Actavis unit.
Mylan launches generic seizure drug in US
US generics manufacturer Mylan announced on 19 January 2016 that it had launched a generic version of Meda Pharms’ Felbatol (felbamate) tablets in dosages of 400 and 600 mg in the US.
Celgene settles Revlimid patent litigation with Natco Pharma
Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Allergan – the license to manufacture and market generic Revlimid (lenalidomide) in the US from 31 January 2026, following expiration of patents in the US in April 2017. This will expedite generics competition for the drug, which currently makes up 60% of Celgene’s annual revenue.
FDA approval for generic antibiotic and arrhythmia drugs
Indian generics maker Glenmark Pharmaceuticals (Glenmark) has gained approval for a generic antibiotic, linezolid, and tentative approval for its generic arrhythmia drug dronedarone.
Roche and India's Glenmark reach truce over generic Tarceva
The Swiss pharmaceutical company F. Hoffmann-La-Roche AG (Roche) has reached an out-of-court settlement with Indian generics company Glenmark Pharmaceuticals (Glenmark) over its patent for its lung cancer drug Tarceva (erlotinib hydrochloride).
Cipla, Glenmark, Sun Pharma bidding for Teva–Allergan generics in the US
Indian generics makers Cipla, Glenmark Pharmaceuticals (Glenmark) and Sun Pharmaceutical Industries (Sun Pharma) are reportedly bidding for a portfolio of US generics from Teva Pharmaceutical Industries (Teva).
Dr Reddy’s faces temporary sales ban on generic esomeprazole
A US court has temporarily banned Dr Reddy’s Laboratories from selling its generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole) in the US over allegations of trademark infringement.
Tentative FDA approval for chemotherapy generic
Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.
Sandoz launches authorized fluvastatin generic in US
Sandoz, the generics division of Novartis, announced on 16 October 2015 the launch of an authorized generic version of Lescol (fluvastatin) tablets.
Teva launches enlarged prostate generic in the US
Generics giant Teva Pharmaceutical Industries (Teva) announced on 12 October 2015 the exclusive launch of generic dutasteride capsules (0.5 mg) in the US.
ADHD generic receives US FDA approval
US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.
Sanofi launches authorized leflunomide generic in US
Sanofi US announced on 1 October 2015 that the company’s US generics division, Winthrop, had launched an authorized generic version of Arava (leflunomide) tablets.
Allergan makes deal with Amneal over its Namenda XR generic
Allergan has gained some breathing space for the extended-release version of its blockbuster Alzheimer’s disease treatment Namenda XR (memantine XR) after making a deal to delay generics entry for more than four years.
FDA approval for guaifenesin generics
Allergan (formerly Actavis) and its partner Perrigo Company (Perrigo) announced on 10 September 2015 that the companies had received US Food and Drug Administration (FDA) approval for their abbreviated new drug applications for three guaifenesin generics.
First generic version of Alzheimer’s patch launched in US
US generics company Alvogen announced on 31 August 2015 the launch of its generic equivalent of Novartis’s Alzheimer’s disease treatment Exelon patch (rivastigmine transdermal system) in the US.
Mylan sued over generic prostate cancer drug
Generics giant Mylan announced on 18 August 2015 that the company was being sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with the filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic abiraterone acetate.
Advocates demand generic version of Abbott’s HIV drug Kaletra
FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.
Yasmin generic launched in US
US generics giant Mylan Pharmaceuticals (Mylan) announced on 8 September 2015 the US launch of its generic version of Bayer’s oral contraceptive pill Yasmin (drospirenone/ethinyl estradiol), following approval by the US Food and Drug Administration (FDA) of its abbreviated new drug applications (ANDA). This marks Mylan’s thirteenth oral contraceptive launch in the US.
US FDA approval for Hep B and osteoporosis generics
Indian generics maker Aurobindo Pharma (Aurobindo) has received US Food and Drug Administration (FDA) approval for two more generics from its portfolio, bringing its total abbreviated new drug application (ANDA) approvals to 210 (182 final and 28 tentative).
Alzheimer generic launched in the US
Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).
Generic Parkinson’s drug hits US market
Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.
ANI Pharmaceuticals acquires 22 generics from Teva
US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 13 July 2015 that it had acquired 22 previously marketed generics from Teva Pharmaceutical Industries (Teva).
Generic bivalirudin approved in US
US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).
