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

Generic Entry Date for aspirin; omeprazole^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Yaling Han	Phase 4

See all aspirin; omeprazole clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; omeprazole

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

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Glossary

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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	205103-002	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
>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

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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	⤷ 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	205103-002	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for aspirin; omeprazole

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Country	Patent Number	Title	Estimated Expiration
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
Mexico	2014007935	COMPOSICIONES Y METODOS MEJORADOS PARA EL SUMINISTRO DE OMEPRAZOL Y DE ACIDO ACETILSALICILICO. (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID.)	⤷ Sign Up
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
>Country	>Patent Number	>Title	>Estimated Expiration

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