Pfizer settles patent disputes with Dexcel, Hikma, and Cipla, extending U.S. exclusivity for VYNDAMAX (tafamidis) to June 2031 and stabilizing projected revenues.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Pfizer has reached settlement agreements with three generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals, and Cipla Ltd in ongoing patent litigation concerning its transthyretin amyloidosis treatment, VYNDAMAX (tafamidis). The cases were filed in the U.S. District Court for the District of Delaware.
Under the terms of the agreements, the effective U.S. patent protection for VYNDAMAX will extend to June 1, 2031, subject to the resolution of any remaining litigation. Pfizer had previously projected a decline in U.S. revenue beginning in 2029 due to anticipated patent expiry. With the new timeline, the company now expects revenues from the drug to remain relatively stable from 2028 through mid-2031.
VYNDAMAX is approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and often underdiagnosed condition affecting the heart. The drug currently holds approximately 75% of prescription volume in the ATTR-CM market.
According to Pfizer, VYNDAMAX is the only once-daily capsule for ATTR-CM shown to significantly reduce both all-cause mortality and cardiovascular-related hospitalizations, with a safety profile comparable to placebo. Clinical evidence supporting the therapy includes data from more than 7,000 patients across trials and registry studies.
In a company statement, Pfizer’s Chief U.S. Commercial Officer Aamir Malik said the settlements affirm the company’s patent position and support continued patient access to the therapy. He emphasized Pfizer’s focus on expanding treatment reach for patients with ATTR-CM.
Separately, Pfizer discontinued the U.S. supply of VYNDAQEL as of December 31, 2025. The company stated that this decision followed consultation with clinicians and patient advocates, who supported transitioning to a single-capsule, once-daily regimen with VYNDAMAX to improve treatment convenience, particularly for patients managing multiple medications.
Reference
Pfizer Reaches Three Settlement Agreements for VYNDAMAX | Pfizer
About the Writer
Samiksha Vikram Jadhav is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.