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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 of HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal

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