Details for New Drug Application (NDA): 211996
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NDA 211996 describes VYNDAQEL, which is a drug marketed by Foldrx Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VYNDAQEL profile page.
The generic ingredient in VYNDAQEL is tafamidis meglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.
The generic ingredient in VYNDAQEL is tafamidis meglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.
Summary for 211996
| Tradename: | VYNDAQEL |
| Applicant: | Foldrx Pharms |
| Ingredient: | tafamidis meglumine |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211996
Generic Entry Date for 211996*:
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: 211996
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1975 | 0069-1975-40 | 4 CARTON in 1 CARTON (0069-1975-40) / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| 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: | 7,214,695 | Patent Expiration: | Dec 19, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 7,214,696 | 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) | ||||||||
Expired US Patents for NDA 211996
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | 8,168,663 | ⤷ Start Trial |
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | 8,653,119 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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