1. Generics Bulletin
  2. >>Business
  3. >>Deals

Zydus And Synthon Sign US Ibrance Generic Deal With Potential Exclusivity

Synthon And Pfizer Settle US Patent Infringement Claims Over $3.1bn Palbociclib Brand

 
• By Urtė Fultinavičiūtė

Zydus and Synthon’s entry into a high-value collaboration on palbociclib tablets is amped up with a paragraph IV certification, which may lead to a 180-day market exclusivity.

Deal handshake agreement document
The paragraph IV certification may grant a six-month market exclusivity • Source: Shutterstock

Zydus Lifesciences has joined forces with Synthon by signing an exclusive licensing and supply agreement for palbociclib. While Synthon will be responsible for the manufacturing, supply, and US Food and Drug Administration registration, Zydus will take care of the drug’s commercialization in the US market.

The kinase inhibitor is a generic version of Pfizer’s oral breast cancer drug Ibrance, which is approved for the treatment...

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
Start Free Trial

Already a subscriber?

More from Deals

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
• By Dean Rudge

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.

More from Business

Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time’

 
• By Dean Rudge

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.