TAFAMIDIS MEGLUMINE - Generic Drug Details
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What are the generic sources for tafamidis meglumine and what is the scope of freedom to operate?
Tafamidis meglumine
is the generic ingredient in one branded drug marketed by Foldrx Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tafamidis meglumine has thirty-five patent family members in seventeen countries.
One supplier is listed for this compound.
Summary for TAFAMIDIS MEGLUMINE
| International Patents: | 35 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| Clinical Trials: | 9 |
| Patent Applications: | 157 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAFAMIDIS MEGLUMINE |
| What excipients (inactive ingredients) are in TAFAMIDIS MEGLUMINE? | TAFAMIDIS MEGLUMINE excipients list |
| DailyMed Link: | TAFAMIDIS MEGLUMINE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAFAMIDIS MEGLUMINE
Generic Entry Date for TAFAMIDIS MEGLUMINE*:
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 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 TAFAMIDIS MEGLUMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
| Pfizer | Phase 1 |
| Pfizer | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for TAFAMIDIS MEGLUMINE
Paragraph IV (Patent) Challenges for TAFAMIDIS MEGLUMINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VYNDAQEL | Capsules | tafamidis meglumine | 20 mg | 211996 | 1 | 2023-05-03 |
US Patents and Regulatory Information for TAFAMIDIS MEGLUMINE
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TAFAMIDIS MEGLUMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TAFAMIDIS MEGLUMINE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2800237 | COMPOSITIONS ET METHODES PERMETTANT DE STABILISER LA TRANSTHYRETINE ET D'INHIBER UN MAUVAIS REPLIEMENT DE LA TRANSTHYRETINE (COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING) | ⤷ Sign Up |
| Denmark | 1587821 | ⤷ Sign Up | |
| South Africa | 200505034 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | ⤷ Sign Up |
| Brazil | PI0317463 | ⤷ Sign Up | |
| Japan | 2010270134 | COMPOSITION AND METHOD FOR STABILIZING TRANSTHYRETIN AND INHIBITING MISFOLDING OF TRANSTHYRETIN | ⤷ Sign Up |
| Australia | 2010201263 | Compositions and methods for stabilizing transthyretin inhibiting transthyretin misfolding | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAFAMIDIS MEGLUMINE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | C01587821/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020 |
| 1587821 | CA 2012 00006 | Denmark | ⤷ Sign Up | |
| 1587821 | SPC/GB12/009 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118 |
| 1587821 | 12C0008 | France | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118 |
| 1587821 | C300516 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TAFAMIDIS MEGLUMINE ZOUT; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | C20120001 00050 | Estonia | ⤷ Sign Up | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
