Details for New Drug Application (NDA): 212161
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NDA 212161 describes VYNDAMAX, which is a drug marketed by Foldrx Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VYNDAMAX profile page.
The generic ingredient in VYNDAMAX is tafamidis. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tafamidis profile page.
The generic ingredient in VYNDAMAX is tafamidis. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tafamidis profile page.
Summary for 212161
| Tradename: | VYNDAMAX |
| Applicant: | Foldrx Pharms |
| Ingredient: | tafamidis |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212161
Generic Entry Date for 212161*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 212161
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8730 | 0069-8730-30 | 30 BLISTER PACK in 1 CARTON (0069-8730-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-8730-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 61MG | ||||
| Approval Date: | May 3, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 19, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 19, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) | ||||||||
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