Vorapaxar sulfate - Generic Drug Details
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What are the generic drug sources for vorapaxar sulfate and what is the scope of patent protection?
Vorapaxar sulfate
is the generic ingredient in one branded drug marketed by Xspire Pharma 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 |
|---|---|
| Matthew Mell | Phase 2 |
| Ken Mahaffey | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xspire Pharma | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Xspire Pharma | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 |
|---|---|---|---|---|---|---|---|
| Xspire Pharma | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vorapaxar sulfate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I331608 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2005070923 | ⤷ Try a Trial | |
| Australia | 6690001 | Thrombin receptor antagonists | ⤷ Try a Trial |
| Russian Federation | 2293735 | ПРОИЗВОДНЫЕ НОР-СЕКО ХИМБАЦИНА, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ИНГИБИРОВАНИЯ НА ИХ ОСНОВЕ (DERIVATIVES OF NOR-SECO-CHIMBACINE, PHARMACEUTICAL COMPOSITION AND METHOD FOR INHIBITING BASED ON THEREOF) | ⤷ Try a Trial |
| European Patent Office | 2301930 | Dérivés der hexaxydrobenzofuranone utiles dans le traitement (de entre autres) maladies auto-immunes ou inflammatoires (Derivatives of hexahydrobenzofuranone useful for the treatment of (inter alia) auto-immune or inflammatory disorders) | ⤷ Try a Trial |
| Australia | 2004276327 | Thrombin receptor anatgonists | ⤷ Try a Trial |
| Israel | 164585 | TRICYCLIC THROMBIN RECEPTOR ANTAGONISTS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vorapaxar sulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1495018 | 2015C/037 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001 |
| 1495018 | 122015000053 | Germany | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119 |
| 1495018 | CR 2015 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119 |
| 1495018 | C20150025 00159 | Estonia | ⤷ Try a Trial | PRODUCT NAME: VORAPAKSAAR;REG NO/DATE: EU/1/14/976 21.01.2015 |
| 1495018 | 300746 | Netherlands | ⤷ Try a Trial | 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 | 218 50011-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121 |
| 1495018 | C 2015 030 | Romania | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR SAU O SARE ACCEPTABILA FARMACEUTIC SAU SOLVATAL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF NATIONAL AUTHORISATION: 20150119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF FIRST AUTHORISATION IN EEA: 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
