Vorapaxar sulfate - Generic Drug Details
✉ Email this page to a colleague
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 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|
| New Zealand | 523075 | Thrombin receptor antagonists | ⤷ Try a Trial |
| Taiwan | 200526643 | Methods of use of thrombin receptor antagonists | ⤷ Try a Trial |
| South Korea | 20060113758 | CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST | ⤷ Try a Trial |
| Australia | 2001266900 | ⤷ Try a Trial | |
| Argentina | 045809 | ANTAGONISTAS DEL RECEPTOR DE TROMBINA | ⤷ Try a Trial |
| Spain | 2338171 | ⤷ 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 | 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 | PA2015027 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VORAPAXARUM; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119 |
| 1495018 | 34/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/976 20150119 |
| 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 | C300746 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR IN ELKE DOOR HET; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119 |
| 1495018 | 132016000023030 | Italy | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR, O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(ZONTIVITY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/976, 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
