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Last Updated: October 22, 2019

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YOSPRALA Drug Profile

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When do Yosprala patents expire, and when can generic versions of Yosprala launch?

Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in twenty-three countries.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aspirin; omeprazole profile page.

Drug patent expirations by year for YOSPRALA
Drug Prices for YOSPRALA

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Recent Clinical Trials for YOSPRALA

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SponsorPhase
POZENPhase 3

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Recent Litigation for YOSPRALA

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 YOSPRALA litigation

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

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Synonyms for YOSPRALA
1259513-22-8
Acetylsalicylic acid - omeprazole mixt.
Aspirin / omeprazole
Aspirin and omeprazole
Aspirin mixture with omeprazole
Benzoic acid, 2-(acetyloxy)-, mixt. with 6-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole
Omeprazole - aspirin mixt.
Omeprazole / Aspirin
Omeprazole mixture with Aspirin
PA 32520
PA 32540
PA-32540
PA32540

US Patents and Regulatory Information for YOSPRALA

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 RX Yes No   Start Trial   Start Trial Y   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   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
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for YOSPRALA
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 81 mg/40 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for YOSPRALA

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 2011/016 Ireland   Start Trial 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 2011C/016 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900 91858 Luxembourg   Start Trial 91858, EXPIRES: 20251105
1411900 435 Finland   Start Trial
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Dow
Moodys
AstraZeneca
Merck

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