KINEVAC Drug Patent Profile
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When do Kinevac patents expire, and when can generic versions of Kinevac launch?
Kinevac is a drug marketed by Bracco and is included in one NDA. There is one patent protecting this drug.
This drug has ten patent family members in eight countries.
The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sincalide profile page.
DrugPatentWatch® Generic Entry Outlook for Kinevac
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 16, 2022. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for KINEVAC
International Patents: | 10 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 1 |
Patent Applications: | 1,969 |
Drug Prices: | Drug price information for KINEVAC |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KINEVAC |
What excipients (inactive ingredients) are in KINEVAC? | KINEVAC excipients list |
DailyMed Link: | KINEVAC at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for KINEVAC
Generic Entry Date for KINEVAC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION |
*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 KINEVAC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Penn State University | N/A |
Memorial Health University Medical Center | N/A |
Temple University | N/A |
Pharmacology for KINEVAC
Drug Class | Cholecystokinin Analog |
Anatomical Therapeutic Chemical (ATC) Classes for KINEVAC
US Patents and Regulatory Information for KINEVAC
KINEVAC is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KINEVAC is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 KINEVAC
Sincalide formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bracco | KINEVAC | sincalide | INJECTABLE;INJECTION | 017697-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 KINEVAC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bracco | KINEVAC | sincalide | INJECTABLE;INJECTION | 017697-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KINEVAC
When does loss-of-exclusivity occur for KINEVAC?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03304382
Estimated Expiration: See Plans and Pricing
Austria
Patent: 2647
Estimated Expiration: See Plans and Pricing
Canada
Patent: 03982
Estimated Expiration: See Plans and Pricing
China
Patent: 56557
Estimated Expiration: See Plans and Pricing
Patent: 0374154
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 31305
Estimated Expiration: See Plans and Pricing
Germany
Patent: 336509
Estimated Expiration: See Plans and Pricing
Japan
Patent: 51993
Estimated Expiration: See Plans and Pricing
Patent: 06515321
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KINEVAC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4751993 | See Plans and Pricing | |
China | 100374154 | See Plans and Pricing | |
France | 2007810 | See Plans and Pricing | |
Canada | 2503982 | FORMULATIONS A BASE DE SINCALIDE (SINCALIDE FORMULATIONS) | See Plans and Pricing |
Switzerland | 517702 | Procédé de préparation de nouveaux peptides | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |