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Patent 1 V13E17

Teva settles patent litigation over ProAir HFA

Generics/News | Posted 04/07/2014

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

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Actavis settles Nuvigil patent litigation, challenges Onglyza patent

Generics/News | Posted 20/06/2014

US generics major Actavis has settled patent litigation related to Actavis’ generic version of Nuvigil (armodafinil) and confirmed its generic Onglyza (saxagliptin) patent challenge.

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First generic celecoxib approved by FDA

Generics/News | Posted 13/06/2014

The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.

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Sun Pharma’s Gujarat site under FDA import alert

Generics/News | Posted 06/06/2014

Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.

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Novartis settles Gleevec lawsuit with Sun Pharma

Generics/News | Posted 02/06/2014

Sun Pharmaceutical Industries (Sun Pharma) announced on 15 May 2014 that it had reached a settlement agreement with originator drug developer Novartis over litigation concerning generic Gleevec (imatinib mesylate).

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FDA sued over generic celecoxib approval

Generics/News | Posted 09/05/2014

Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

Taiwan TWi gains FDA approval for generic nifedipine

Generics/News | Posted 11/04/2014

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

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Dr Reddy’s launches generic amlodipine/atorvastatin

Generics/News | Posted 04/04/2014

Indian generics giant Dr Reddy’s announced on 27 March 2014 the launch of its generic amlodipine/atorvastatin tablets in the US.

Celecoxib

Celecoxib generics could come sooner than expected

Generics/News | Posted 28/03/2014

Pharma giant Pfizer confirmed on 12 March 2014 that the United States District Court for East Virginia had invalidated its reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in its blockbuster anti-inflammatory painkiller Celebrex.

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Indian generics makers face US recalls

Generics/News | Posted 21/03/2014

Indian generics makers are once again coming under US Food and Drug Administration (FDA) scrutiny.

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FDA approves generic osteoporosis drug

Generics/News | Posted 14/03/2014

FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).

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Teva and Ranbaxy settle unlawful competition investigation

Generics/News | Posted 07/03/2014

New York Attorney General Eric Schneiderman announced on 19 February 2014 that he had reached a settlement with generics makers Ranbaxy Pharmaceuticals (Ranbaxy) and Teva Pharmaceuticals (Teva) for entering into an anti-competitive arrangement.

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Gilead to license hepatitis C drug to Indian generics firms

Generics/News | Posted 21/02/2014

Gilead Sciences (Gilead) has announced plans to license its breakthrough hepatitis C drug Sovaldi (sofosbuvir) to at least three Indian generics manufacturers. The announcement made in February 2014, comes three months after the company faced a ‘patent opposition’ filed at India’s Patent Office, which aimed to block them from gaining a patent for Sovaldi in India.

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Sandoz gains Belgian approval for generic inhalation device

Generics/News | Posted 14/02/2014

In an example of the innovative nature of generics manufacturers, Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 12 February 2014 that it had received marketing authorization in Belgium for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

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Forest Labs files lawsuit to stop generic memantine

Generics/News | Posted 07/02/2014

Forest Laboratories and Forest Laboratories Holdings (Forest) announced on 31 January 2014 that the company has filed a lawsuit in the US against several generics makers for their generic versions of Forest’s blockbuster Alzheimer’s disease treatment Namenda XR (memantine).

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FDA issues Ranbaxy with Form 483 for violations at Toansa plant

Generics/News | Posted 24/01/2014

Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a Form 483 by FDA.

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ANI Pharmaceuticals acquires 31 generics from Teva

Generics/News | Posted 17/01/2014

US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 26 December 2013 that it had acquired 31 previously marketed generic drugs from Teva Pharmaceutical Industries (Teva).

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Sandoz gains Danish approval for innovative asthma inhaler

Generics/News | Posted 10/01/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).