YOSPRALA Drug Patent Profile
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Which patents cover Yosprala, 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. Two suppliers are listed for this compound. Additional details are available on the aspirin; omeprazole profile page.
DrugPatentWatch® Generic Entry Outlook for Yosprala
There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for YOSPRALA
| International Patents: | 46 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for YOSPRALA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for YOSPRALA |
| What excipients (inactive ingredients) are in YOSPRALA? | YOSPRALA excipients list |
| DailyMed Link: | YOSPRALA at DailyMed |
Paragraph IV (Patent) Challenges for YOSPRALA
| 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 YOSPRALA
YOSPRALA is protected by five US patents.
Patents protecting YOSPRALA
Pharmaceutical compositions for the coordinated delivery of NSAIDs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Pharmaceutical compositions for the coordinated delivery of NSAIDs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Pharmaceutical compositions for the coordinated delivery of NSAIDs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 YOSPRALA
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for YOSPRALA
See the table below for patents covering YOSPRALA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 006398 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КООРДИНИРОВАННОЙ ДОСТАВКИ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ (PHARMACEUTICAL COMPOSITIONS FOR COORDINATED DELIVERY OF NSAIDS) | ⤷ Try a Trial |
| Australia | 2009290712 | Method for delivering a pharmaceutical composition to patient in need thereof | ⤷ Try a Trial |
| Tunisia | 2011000096 | METHOD FOR DELIVERING A PHARMACEUTICAL COMPOSITION TO PATIENT IN NEED THEREOF | ⤷ Try a Trial |
| Australia | 2006235929 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for YOSPRALA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 435 | Finland | ⤷ Try a Trial | |
| 1411900 | CA 2012 00036 | Denmark | ⤷ Try a Trial | |
| 1411900 | C01411900/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: POZEN, INC., US |
| 1411900 | C300481 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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