Teva launches generic tadalafil but delays launch of generic Suboxone

Generics/News | Posted 19/10/2018 post-comment0 Post your comment

Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delaying the launch of its higher-dose Suboxone (buprenorphine/naloxone) generic.

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The Israeli generics giant announced on 27 September 2018 its launch of its first-to-file generic tadalafil tablets, used to treat male impotence, in dosages of 2.5, 5, 10 and 20 mg in the US.

Teva’s generic tadalafil tablets are a generic alternative to Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil). Cialis has generated more than US$17 billion in sales during its patent life, which now extends at least until 27 September 2018, with some patents only expiring in 2021. Cialis also has paediatric exclusivity which will only expire in 2021.

However, Teva has agreed to delay the launch of its higher-dose generic version of Indivior’s blockbuster opioid addiction drug Suboxone until the resolution of a US Court case involving rival generics maker Dr Reddy’s Laboratories (Dr Reddy’s), Indivior said on 10 September 2018.

Indivior has filed patent lawsuits against Dr Reddy’s, Actavis, Par, Alvogen and Teva for infringement of US Patent No. 9,931,305 (the ‘305 patent) relating to their respective proposed generic versions of the company’s Suboxone (buprenorphine and naloxone) sublingual film product (applied under the tongue).

Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs and naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment programme including prescription monitoring, counselling and psychosocial support.

Indian generics maker Dr Reddy’s and US-based drugmaker Mylan received approval for their generics of Suboxone in June 2018 [1]. Teva received US Food and Drug Administration (FDA) approval for Cassipa, which is its higher-dosage strength generic buprenorphine/naloxone (16 milligrams/4 milligrams), in September 2018.

FDA said that ‘there’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment (MAT) for opioid use disorder’. The agency added that ‘improving access to prevention, treatment and recovery services, including the full range of MAT, is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the US Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first Suboxone generics for opioid dependence []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from:

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Source: Indivior, Reuters, Teva, US FDA

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