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Mylan Is Latest Entrant On US Generic Suboxone

 
• By Dave Wallace

Mylan has joined Alvogen, Dr Reddy’s and Sandoz in the battle over US generic versions of Indivior’s Suboxone sublingual film. However, it is only marketing two of the four strengths offered by its rivals.

Hat
Mylan Is Throwing Its Hat Into The Ring On Generic Suboxone • Source: Shutterstock

Mylan has launched a generic version of Indivior’s Suboxone (buprenorphine/naloxone) in the US, hot on the heels of launches by Alvogen and Dr Reddy’s as well as Sandoz’ introduction of an authorized generic.

However, the 8mg/2mg and 12mg/3mg strengths launched by Mylan represent only two of the four strengths covered by the other...

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Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
• By Dave Wallace

As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

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• By Dave Wallace

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Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.

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• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By Dave Wallace

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

 
• By Urtė Fultinavičiūtė

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.