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: | 14 |
| 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
*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 |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Yaling Han | 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 | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ASPIRIN; OMEPRAZOLE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 201491285 | УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ | ⤷ Sign Up |
| Canada | 2860231 | COMPOSITIONS ET PROCEDES D'ADMINISTRATION D'OMEPRAZOLE PLUS ACIDE ACETYLSALICYLIQUE AMELIORES (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID) | ⤷ Sign Up |
| Ukraine | 115139 | СПОСІБ ДОСТАВКИ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ, ЯКА МІСТИТЬ ОМЕПРАЗОЛ Й АЦЕТИЛСАЛІЦИЛОВУ КИСЛОТУ, ПАЦІЄНТУ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2013101897 | ⤷ Sign Up | |
| Brazil | 112014016085 | composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
