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VYNDAMAX Drug Profile
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» See Plans and PricingWhen do Vyndamax patents expire, and when can generic versions of Vyndamax launch?
Vyndamax is a drug marketed by Foldrx Pharms and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-two patent family members in twenty-three countries.
The generic ingredient in VYNDAMAX is tafamidis. One supplier is listed for this compound. Additional details are available on the tafamidis profile page.
US ANDA Litigation and Generic Entry Outlook for Vyndamax
Vyndamax will be eligible for patent challenges on May 3, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 31, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYNDAMAX
| International Patents: | 52 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 46 |
| Patent Applications: | 26 |
| Drug Prices: | Drug price information for VYNDAMAX |
| DailyMed Link: | VYNDAMAX at DailyMed |
Generic Entry Opportunity Date for VYNDAMAX
Generic Entry Date for VYNDAMAX*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for VYNDAMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VYNDAMAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2010201263 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016038500 | Start Trial |
| Russian Federation | 2017107235 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYNDAMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | 1290005-6 | Sweden | Start Trial | PRODUCT NAME: TAFAMIDIS; REG. NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | CA 2012 00006 | Denmark | Start Trial | |
| 1587821 | 382 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
