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VYNDAQEL Drug Profile
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» See Plans and PricingWhich patents cover Vyndaqel, and when can generic versions of Vyndaqel launch?
Vyndaqel is a drug marketed by Foldrx Pharms and is included in one NDA. There are four patents protecting this drug.
This drug has thirty-five patent family members in seventeen countries.
The generic ingredient in VYNDAQEL is tafamidis meglumine. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.
US ANDA Litigation and Generic Entry Outlook for Vyndaqel
Vyndaqel 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 May 3, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYNDAQEL
| International Patents: | 35 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 3 |
| Drug Prices: | Drug price information for VYNDAQEL |
| DailyMed Link: | VYNDAQEL at DailyMed |
Generic Entry Opportunity Date for VYNDAQEL
Generic Entry Date for VYNDAQEL*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION 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.
Recent Clinical Trials for VYNDAQEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Pfizer | N/A |
US Patents and Regulatory Information for VYNDAQEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | 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 VYNDAQEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2010201263 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004056315 | Start Trial |
| Brazil | PI0317463 | Start Trial |
| Germany | 60323155 | Start Trial |
| Canada | 2800237 | Start Trial |
| European Patent Office | 1988397 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYNDAQEL
| 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 | CR 2012 00006 | Denmark | Start Trial | PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | CA 2012 00006 | Denmark | Start Trial | |
| 1587821 | C 2012 004 | Romania | Start Trial | PRODUCT NAME: TAFAMIDISMEGLUMINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/717/001; DATE OF NATIONAL AUTHORISATION: 20111116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/717/001; DATE OF FIRST AUTHORISATION IN EEA: 20111116 |
| 1587821 | 6/2012 | Austria | Start Trial | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | 2012/007 | Ireland | Start Trial | PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
