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Industry Impact Weighed As US Supreme Court Refuses Skinny-Label Review

Teva Vows To Fight On With ‘Additional Defenses’ As Case Returns To District Court

 
• By Dave Wallace

Teva has been denied in its attempt to convince the US Supreme Court to re-examine long-running litigation with GSK over skinny-label carve-outs of generic indications. However, the generics firm has vowed to fight on as the case is returned to the district court level, while the wider off-patent industry weighs the impact of the latest decision.

Supreme Court long shot
The Supreme Court has declined to rehear the GSK-Teva litigation

Teva has been dealt a blow in attempts to push back in long-running litigation with GlaxoSmithKline over “skinny-label” carve-outs of generic indications in the US, after the Supreme Court refused the generics firm’s petition for certiorari review of the case.

Revolving around allegations of induced infringement, the case is focused on Teva’s generic version of Coreg (carvedilol) that carved out a congestive heart failure indication protected by GSK’s reissued US patent RE40,000. A number of rulings from various courts over the years ultimately resulted in GSK in 2020 seeing reinstated a jury finding of infringement and a $235m damages award from 2017

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Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By Dean Rudge

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

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Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 
• By Urtė Fultinavičiūtė

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By Dean Rudge

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

Viatris Awaits ‘Significant Rebound’ At Indore In 2026 After Painful Q1 Bite

 
• By Dean Rudge

Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.