Tafamidis Patent Expiration
Tafamidis is used for treating cardiomyopathy associated with wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) It was first introduced by Foldrx Pharmaceuticals Llc A Wholly Owned Sub Of Pfizer Inc
Tafamidis Patents
Given below is the list of patents protecting Tafamidis, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Vyndamax | US9770441 | Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole | Aug 31, 2035 | Foldrx Pharms |
| Vyndamax | US7214695 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | Dec 19, 2026 | Foldrx Pharms |
| Vyndamax | US7214696 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | Dec 19, 2026 | Foldrx Pharms |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Tafamidis's patents.
Latest Legal Activities on Tafamidis's Patents
Given below is the list recent legal activities going on the following patents of Tafamidis.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Interim Patent Term Extension Granted | 15 Aug, 2025 | US7214695 |
| Interim Patent Term Extension Granted | 15 Aug, 2025 | US7214696 |
| Interim Patent Term Extension Request Under 35 USC 156(e)(2) | 13 Aug, 2025 | US7214696 |
| Interim Patent Term Extension Request Under 35 USC 156(e)(2) | 13 Aug, 2025 | US7214695 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2025 | US9770441 |
| transaction for FDA Determination of Regulatory Review Period | 30 Oct, 2024 | US7214695 |
| transaction for FDA Determination of Regulatory Review Period | 21 Oct, 2024 | US7214696 |
| transaction for FDA Determination of Regulatory Review Period | 21 Oct, 2024 | US7214695 |
| Interim Patent Term Extension Granted | 17 Sep, 2024 | US7214695 |
| Interim Patent Term Extension Granted | 17 Sep, 2024 | US7214696 |
Tafamidis's Family Patents
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Clinical Trials
Recent Clinical Trials on Tafamidis:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
| ||||
| A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions | Pfizer | NA |
COMPLETED
(Aug 1, 2026)
| PHASE1 |
| A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions | Pfizer | NA |
TERMINATED
(Jun 1, 2026)
| PHASE1 |