YOSPRALA Drug Patent Profile
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Which patents cover Yosprala, and when can generic versions of Yosprala launch?
Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has nine patent family members in eight countries.
The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.
DrugPatentWatch® Generic Entry Outlook for Yosprala
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 2, 2033. This may change due to patent challenges or generic licensing.
There have been eleven 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 YOSPRALA
International Patents: | 9 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 3 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for YOSPRALA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for YOSPRALA |
What excipients (inactive ingredients) are in YOSPRALA? | YOSPRALA excipients list |
DailyMed Link: | YOSPRALA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for YOSPRALA
Generic Entry Date for YOSPRALA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, DELAYED RELEASE;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 YOSPRALA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
POZEN | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for YOSPRALA
Paragraph IV (Patent) Challenges for YOSPRALA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
YOSPRALA | Delayed-release Tablets | aspirin; omeprazole | 81 mg/40 mg and 325 mg/40 mg | 205103 | 1 | 2016-10-17 |
YOSPRALA | Delayed-release Tablets | aspirin; omeprazole | 81 mg/40 mg and 325 mg/40 mg | 205103 | 1 | 2016-10-14 |
US Patents and Regulatory Information for YOSPRALA
YOSPRALA is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of YOSPRALA 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 YOSPRALA
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 YOSPRALA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for YOSPRALA
When does loss-of-exclusivity occur for YOSPRALA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Brazil
Patent: 2014016085
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 60231
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4519888
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8049
Estimated Expiration: ⤷ Try a Trial
Patent: 1491285
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 97600
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 14007935
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 5139
Estimated Expiration: ⤷ 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.
See the table below for additional patents covering YOSPRALA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2163241 | Compositions pharmaceutiques pour l'administration coordonnée d'AINS (Pharmaceutical compositions for the coordinated delivery of NSAIDs) | ⤷ Try a Trial |
European Patent Office | 2344139 | PROCÉDÉ D'ADMINISTRATION D'UNE COMPOSITION PHARMACEUTIQUE À UN PATIENT EN AYANT BESOIN (METHOD FOR DELIVERING A PHARMACEUTICAL COMPOSITION TO PATIENT IN NEED THEREOF) | ⤷ Try a Trial |
Eurasian Patent Organization | 200301321 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КООРДИНИРОВАННОЙ ДОСТАВКИ СРЕДСТВ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Try a Trial |
China | 104519888 | Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid | ⤷ Try a Trial |
Australia | 2009200966 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for YOSPRALA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | 1190013-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
1411900 | 91858 | Luxembourg | ⤷ Try a Trial | 91858, EXPIRES: 20251105 |
1411900 | 2011/016 | Ireland | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
1411900 | 435 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |