Aspirin; omeprazole - Generic Drug Details
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What are the generic sources for aspirin; omeprazole and what is the scope of freedom to operate?
Aspirin; omeprazole
is the generic ingredient in one branded drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Aspirin; omeprazole has nine patent family members in eight countries.
Summary for aspirin; omeprazole
| International Patents: | 9 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 15 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aspirin; omeprazole |
| DailyMed Link: | aspirin; omeprazole at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aspirin; omeprazole
Generic Entry Date for aspirin; omeprazole*:
Constraining patent/regulatory exclusivity:
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 aspirin; omeprazole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Michigan Rogel Cancer Center | EARLY_PHASE1 |
| National Cancer Institute (NCI) | EARLY_PHASE1 |
| Federal University of São Paulo | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for aspirin; omeprazole
Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE
| 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 aspirin; omeprazole
| 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 | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | 9,987,231 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | 9,539,214 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | 9,539,214 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | 9,987,231 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >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 aspirin; omeprazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | 9,364,439 | ⤷ Get Started Free |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | 6,926,907 | ⤷ Get Started Free |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | 6,926,907 | ⤷ Get Started Free |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | 9,364,439 | ⤷ Get Started Free |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | 8,206,741 | ⤷ Get Started Free |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | 8,206,741 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aspirin; omeprazole
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 104519888 | Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid | ⤷ Get Started Free |
| Brazil | 112014016085 | composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico | ⤷ Get Started Free |
| Eurasian Patent Organization | 201491285 | УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ | ⤷ Get Started Free |
| World Intellectual Property Organization (WIPO) | 2013101897 | ⤷ Get Started Free | |
| Brazil | 112014016085 | composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico | ⤷ Get Started Free |
| European Patent Office | 2797600 | COMPOSITIONS ET PROCÉDÉS D'ADMINISTRATION D'OMÉPRAZOLE PLUS ACIDE ACÉTYLSALICYLIQUE AMÉLIORÉS (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID) | ⤷ Get Started Free |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Aspirin and Omeprazole
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