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Last Updated: August 15, 2022

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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aspirin; omeprazole has forty-six patent family members in twenty-three countries.

Two suppliers are listed for this compound.

Summary for aspirin; omeprazole
Recent Clinical Trials for aspirin; omeprazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
Yaling HanPhase 4

See all aspirin; omeprazole clinical trials

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 2016-10-14

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing 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 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 See Plans and Pricing See Plans and Pricing
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aspirin; omeprazole

Country Patent Number Title Estimated Expiration
Japan 2004536809 See Plans and Pricing
European Patent Office 1411900 COMPOSITIONS PHARMACEUTIQUES DESTINEES A LA LIBERATION COORDONNEE D'AINS (PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDs) See Plans and Pricing
European Patent Office 2260837 Compositions pharmaceutiques pour l'administration coordonnée d'AINS (Pharmaceutical compositions for the coordinated delivery of NSAIDs) See Plans and Pricing
Norway 2013014 See Plans and Pricing
Japan 4756823 See Plans and Pricing
Cyprus 1110842 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aspirin; omeprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland See Plans and Pricing 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 91858 Luxembourg See Plans and Pricing 91858, EXPIRES: 20251105
1411900 2011C/016 Belgium See Plans and Pricing PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900 1190013-1 Sweden See Plans and Pricing PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 C01411900/01 Switzerland See Plans and Pricing FORMER OWNER: POZEN, INC., US
1411900 SPC/GB11/015 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Johnson and Johnson
AstraZeneca
Mallinckrodt
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.