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McKinsey
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Generated: March 20, 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-five 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. Two suppliers are listed for this compound. Additional details are available on the aspirin; omeprazole profile page.

Drug patent expirations by year for YOSPRALA
Generic Entry Opportunity Date for YOSPRALA
Generic Entry Date for YOSPRALA*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
NDA:
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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for YOSPRALA
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 81 mg/40 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for YOSPRALA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011C/016 Belgium ➤ Try a Free Trial PRODUCT NAME: VIMOVO 500MG/20MG TABLETTEN MET HEREGULEERDE AFGIFTE; AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900 122012000052 Germany ➤ Try a Free Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 435 Finland ➤ Try a Free Trial
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Harvard Business School

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