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Way cleared in US for Suboxone and Zytiga generics Posted 07/12/2018

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a decision to invalidate Johnson & Johnson’s (J&J) patent on its blockbuster prostate cancer drug Zytiga (abiraterone).

On 19 November 2018, the US Court of Appeals for the Federal Circuit rejected a request by J&J for a temporary restraining order blocking sales of generic versions of its blockbuster prostate cancer drug Zytiga. The court said it would not block Mylan and other companies from selling generic versions of Zytiga while J&J seeks emergency relief at the US Supreme Court.

J&J first sued Mylan back in 2015 when the company filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic abiraterone acetate [1]. Mylan, as well as Apotex, Teva and Hikma, received approval for their abiraterone generics on 31 October 2018.

J&J then appealed an October 2018 decision by the US District Court of New Jersey that ruled that its US patent (No. 8822438) for Zytiga was invalid, clearing the way for generics of the drug to be launched in the US [2]. In its appeal J&J requested that that the court block sales of generics until the appeal is decided. However, although this request was denied, the court said that the decision should not be seen as indicating which side will ultimately win.

Then on 20 November 2018, the US Court of Appeals for the Federal Circuit ruled that Indivior had ‘not shown that it is likely to succeed on the merits of its infringement claim’ on US Patent No. 9,931,305 (the ‘305 patent). This overturned the preliminary injunction granted by the US District Court of New Jersey in July 2018.

Indivior has filed patent lawsuits against Dr Reddy’s, Actavis, Par, Alvogen and Teva for infringement of its ‘305 patent relating to their respective proposed generic versions of the company’s Suboxone (buprenorphine and naloxone) sublingual film product (applied under the tongue) [3].

Dr Reddy’s received approval for its buprenorphine/naloxone generic from FDA in June 2018 [4], but had been prevented from selling the opioid dependence treatment by the injunction. The company said that it was ‘pleased with the decision of the appellate court in Dr Reddy’s favour, vacating the preliminary injunction that had prevented Dr Reddy’s from bringing this important drug to the public’. Indivior, on the other hand, said that it will file a petition for a panel rehearing of the ruling overturning the injunction.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan sued over generic prostate cancer drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Generics/News/Mylan-sued-over-generic-prostate-cancer-drug
2. GaBI Online - Generics and Biosimilars Initiative. Generics companies winning the legal battle in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Generics/News/Generics-companies-winning-the-legal-battle-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Teva launches generic tadalafil but delays launch of generic Suboxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Generics/News/Teva-launches-generic-tadalafil-but-delays-launch-of-generic-Suboxone
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first Suboxone generics for opioid dependence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Generics/News/FDA-approves-first-Suboxone-generics-for-opioid-dependence

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Source: Dr Reddy’s, Indivior, Reuters, US Court of Appeals, US FDA

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