Lupin Kicks Off 2024 With Major US Generics Launches

Introduces Rival To Prolensa With 180-Day Exclusivity And Challenges Chantix

Lupin has begun 2024 by notching up multiple US approvals and launches, including introducing an exclusive generic version of Prolensa and challenging Chantix.

Shutterstock
Lupin has burst into 2024 with multiple approvals and launches

Lupin has kicked off the new year with multiple US launches and approvals, chief among them its introduction of the first generic rival to Bausch + Lomb’s Prolensa (bromfenac) 0.07% ophthalmic solution, for which the Indian firm will enjoy 180-day first-to-file exclusivity.

Towards the end of November 2023, Lupin received approval for its generic from the US Food and Drug Administration (see...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By 

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By 

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

UPC Imposes Wide Cross-Border Injunction On Zentiva In Ofev Patent Clash

 
• By 

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

More from Products

Henlius And Organon Sued In US Over Plans To Market Perjeta Biosimilar

 
• By 

Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.

Accord Takes On Ustekinumab Rivals In US With Steepest Discount Yet

 
• By 

Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By 

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.