Vorapaxar sulfate - Generic Drug Details
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What are the generic sources for vorapaxar sulfate and what is the scope of freedom to operate?
Vorapaxar sulfate
is the generic ingredient in one branded drug marketed by Key Therap and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vorapaxar sulfate has one hundred and sixty-four patent family members in thirty-seven countries.
Summary for vorapaxar sulfate
International Patents: | 164 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
Patent Applications: | 19 |
DailyMed Link: | vorapaxar sulfate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vorapaxar sulfate
Generic Entry Date for vorapaxar sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 vorapaxar sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ken Mahaffey | Phase 2 |
Merck Sharp & Dohme Corp. | Phase 2 |
Matthew Mell | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for vorapaxar sulfate
US Patents and Regulatory Information for vorapaxar sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | 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 vorapaxar sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vorapaxar sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2007517804 | ⤷ Sign Up | |
Germany | 60331114 | ⤷ Sign Up | |
South Korea | 20110039402 | PROCESS FOR PREPARING CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST | ⤷ Sign Up |
Taiwan | 200524914 | Thrombin receptor antagonists | ⤷ Sign Up |
Japan | 2007056043 | THROMBIN RECEPTOR ANTAGONIST | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2005030712 | ⤷ Sign Up | |
Canada | 2552786 | POLYMORPHE CRISTALLIN D'UN SEL BISULFATE D'UN ANTAGONISTE DERECEPTEUR DE THROMBINE (CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vorapaxar sulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1495018 | C01495018/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65803 19.09.2016 |
1495018 | CR 2015 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119 |
1495018 | CA 2015 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119 |
1495018 | SPC/GB15/039 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/976/001 20150121; UK EU/1/14/976/002 20150121; UK EU/1/14/976/003 20150121; UK EU/1/14/976/004 20150121; UK EU/1/14/976/005 20150121; UK EU/1/14/976/006 20150121 |
1495018 | 300746 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER VORAPAXARSULFAAT; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150121 |
1495018 | PA2015027 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VORAPAXARUM; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119 |
1495018 | 1590037-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/976/001 20150121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |