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Last Updated: November 13, 2019

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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.

There are twenty-two drug master file entries for aspirin; omeprazole. Three 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

Recent Litigation for aspirin; omeprazole

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-01-23
HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.2015-05-13
HORIZON PHARMA, INC. v. ACTAVIS LABORATORIES FL., INC.2015-05-13

See all aspirin; omeprazole litigation

PTAB Litigation
PetitionerDate
Coalition for Affordable Drugs VII LLC2015-05-21

See all aspirin; omeprazole litigation

Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
YOSPRALA TABLET, DELAYED RELEASE;ORAL aspirin; omeprazole 205103 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 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for aspirin; omeprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 18/2011 Austria   Start Trial PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900 2011C/016 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900 122012000052 Germany   Start Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 CA 2012 00036 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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