Generics/News

Generics of ADHD drug launched in US

Generics/News | Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

Osteoporosis and ADHD generics launched in USA

Generics/News | Posted 12/06/2015

On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.

FDA receives application for first generic of HIV drug dolutegravir

Generics/News | Posted 05/06/2015

India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).

Generics of high blood pressure medication launched

Generics/News | Posted 22/05/2015

On 31 March 2015, generics majors Mylan, Sandoz and Teva Pharmaceutical Industries (Teva) announced the US launch of their respective generic amlodipine and valsartan combination tablets in four dosages.

TWi and Takeda settle dispute over anti-reflux generic

Generics/News | Posted 15/05/2015

Taiwan-based TWi Pharmaceuticals (TWi) announced on 27 April 2015 that it had entered into a settlement agreement with Takeda Pharmaceutical Company, Takeda Pharmaceuticals USA and Takeda Pharmaceuticals America (Takeda) to settle and dismiss all outstanding patent litigation related to TWi’s generic dexlansoprazole.

FDA approves first generics of antipsychotic drug

Generics/News | Posted 04/05/2015

The US Food and Drug Administration (FDA) announced on 28 April 2015 the approval of the first generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole).

IDT Australia gets FDA nod for 23 generics

Generics/News | Posted 17/04/2015

IDT Australia announced on 13 April 2015 that the US Food and Drug Administration (FDA) had accepted the transfer of ownership of 23 generics to the Australia-based company.

Shire grabs Par’s attention with patent lawsuit

Generics/News | Posted 03/04/2015

Shire has served its rival Par Pharmaceutical (Par) with a patent infringement lawsuit in New Jersey Federal Court over Par's application to market a generic version of Shire's attention deficit hyperactivity disorder medication Adderall XR.

Actavis loses Atelvia patents

Generics/News | Posted 27/03/2015

Teva Pharmaceutical Industries (Teva) has won a legal battle against Actavis after a federal judge invalidated two patents protecting the post-menopausal osteoporosis drug Atelvia (risedronate sodium delayed-release tablets, 35 mg). Actavis acquired Atelvia in 2013 when it bought Irish drugmaker Warner Chilcott [1], which continues to produce the drug as an Actavis subsidiary.

Ranbaxy fails to reverse FDA decision over Valcyte and Nexium

Generics/News | Posted 20/03/2015

Indian generics company Ranbaxy has yet again failed in its bid to become the first company in the US to sell generic versions of the AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir). Launching the first generic copies of the drugs would have given Ranbaxy six months of exclusivity on the market.

Drug companies seek to block generic version of ulcerative colitis therapy

Generics/News | Posted 13/03/2015

The patent holder and manufacturer of Uceris (budesonide), a treatment for ulcerative colitis, have sued generics company Actavis for infringing their drug’s patents. Actavis recently filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Budesonide extended-release tablets, 9 mg.

US court invalidates asthma drug patent

Generics/News | Posted 06/03/2015

The US District Court of New Jersey ruled on 13 February 2015 that the patent protecting AstraZeneca’s inhaled asthma drug Pulmicort Respules (budesonide inhalation suspension) is invalid, opening the door to competition from generics.

Actavis receives generic opioid approval and plans name change

Generics/News | Posted 27/02/2015

US generics maker Actavis announced on 20 February 2015 that it had received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Reckitt Benckiser’s Subutex (buprenorphine) sublingual tablets in dosages of 2 and 8 mg.

Mylan being sued over sorafenib generic

Generics/News | Posted 20/02/2015

US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).

Dr Reddy’s could move manufacturing site with view to FDA approval

Generics/News | Posted 13/02/2015

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.

Akorn submits ANDA for difluprednate ophthalmic emulsion

Generics/News | Posted 06/02/2015

US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.

FDA approves first generic esomeprazole

Generics/News | Posted 30/01/2015

Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.

Prasco to market authorized colchicine generic in the US

Generics/News | Posted 23/01/2015

US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute an authorized generic version of Colcrys (colchicine) in the US.

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