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 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 |
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 |
|---|---|---|---|
| Slovenia | 1294714 | ⤷ Try a Trial | |
| Ecuador | SP045368 | "ANTAGONISTAS DE LOS RECEPTORES DE TROMBINA" | ⤷ Try a Trial |
| European Patent Office | 1701953 | Procédé de préparation d'un polymorphe cristallin d'un sel bisulfate d'un antagoniste de récepteur de thrombine (Process for the production of a crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist) | ⤷ Try a Trial |
| Cyprus | 1111363 | ⤷ Try a Trial | |
| Taiwan | 200524914 | Thrombin receptor antagonists | ⤷ Try a Trial |
| Israel | 174538 | ⤷ 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 | 2015/035 | Ireland | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119 |
| 1495018 | C01495018/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65803 19.09.2016 |
| 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 | C20150025 00159 | Estonia | ⤷ Try a Trial | PRODUCT NAME: VORAPAKSAAR;REG NO/DATE: EU/1/14/976 21.01.2015 |
| 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 |
| 1495018 | PA2015027,C1495018 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VORAPAKSARAS; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
