ZONTIVITY Drug Patent Profile
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Which patents cover Zontivity, and when can generic versions of Zontivity launch?
Zontivity is a drug marketed by Xspire Pharma and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and sixty-four patent family members in thirty-seven countries.
The generic ingredient in ZONTIVITY is vorapaxar sulfate. Additional details are available on the vorapaxar sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Zontivity
Zontivity was eligible for patent challenges on May 8, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 23, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ZONTIVITY
| International Patents: | 164 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Clinical Trials: | 5 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for ZONTIVITY |
| What excipients (inactive ingredients) are in ZONTIVITY? | ZONTIVITY excipients list |
| DailyMed Link: | ZONTIVITY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZONTIVITY
Generic Entry Date for ZONTIVITY*:
Constraining patent/regulatory exclusivity:
NDA:
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 ZONTIVITY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt University | Phase 4 |
| Vanderbilt University Medical Center | Phase 4 |
| University of Florida | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ZONTIVITY
US Patents and Regulatory Information for ZONTIVITY
ZONTIVITY is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZONTIVITY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZONTIVITY
Thrombin receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS
Thrombin receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS IN PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION (MI) OR WITH PERIPHERAL ARTERIAL DISEASE (PAD)
| 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 ZONTIVITY
| 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 ZONTIVITY
See the table below for patents covering ZONTIVITY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0196330 | ⤷ Try a Trial | |
| South Africa | 200408342 | Tricyclic thrombin receptor antagonists | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2005046688 | ⤷ Try a Trial | |
| Australia | 6690001 | Thrombin receptor antagonists | ⤷ 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZONTIVITY
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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