Home / Generics / News

News

Teva wins another Symbicort patent challenge

Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.

FDA accepts applications for three-times-weekly follow-on Copaxone

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Generics companies sue Reckitt Benckisser over generics supplies

Three generics companies are suing Reckitt Benckisser (Reckitt) for failing to provide generics supplies of its cold and flu medicine Mucinex (guaifenesin) in line with an agreement struck in 2007.

US court puts generic Gralise on hold

US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment for neuropathic pain, Gralise (gabapentin).

Generics manufacturers focus on MS drug Ampyra

Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.

Actavis submits generic dalfampridine ANDA

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Generic valsartan approved in US

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

Teva settles patent litigation over ProAir HFA

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).

Actavis settles Nuvigil patent litigation, challenges Onglyza patent

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

First generic celecoxib approved by FDA

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

Generics News Research General

more

Biosimilars News Research General

more