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Generics of ADHD drug launched in US

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

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

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

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

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

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

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

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

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

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.