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 two patents protecting this drug and two Paragraph IV challenges.
This drug has nine patent family members in eight countries.
The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.
DrugPatentWatch® Generic Entry Outlook for Yosprala
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 2, 2033. This may change due to patent challenges or generic licensing.
There have been eleven 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
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Summary for YOSPRALA
| International Patents: | 9 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for YOSPRALA
*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.
Recent Clinical Trials for YOSPRALA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| POZEN | Phase 3 |
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 | 2016-10-17 |
| 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 two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of YOSPRALA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting YOSPRALA
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for YOSPRALA
When does loss-of-exclusivity occur for YOSPRALA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Brazil
Patent: 2014016085
Patent: composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 60231
Patent: COMPOSITIONS ET PROCEDES D'ADMINISTRATION D'OMEPRAZOLE PLUS ACIDE ACETYLSALICYLIQUE AMELIORES (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4519888
Patent: Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8049
Patent: УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Estimated Expiration: ⤷ Sign Up
Patent: 1491285
Patent: УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 97600
Patent: COMPOSITIONS ET PROCÉDÉS D'ADMINISTRATION D'OMÉPRAZOLE PLUS ACIDE ACÉTYLSALICYLIQUE AMÉLIORÉS (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 14007935
Patent: COMPOSICIONES Y METODOS MEJORADOS PARA EL SUMINISTRO DE OMEPRAZOL Y DE ACIDO ACETILSALICILICO. (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID.)
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5139
Patent: СПОСІБ ДОСТАВКИ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ, ЯКА МІСТИТЬ ОМЕПРАЗОЛ Й АЦЕТИЛСАЛІЦИЛОВУ КИСЛОТУ, ПАЦІЄНТУ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering YOSPRALA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 104519888 | Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid | ⤷ Sign Up |
| Canada | 2449098 | COMPOSITIONS PHARMACEUTIQUES DESTINEES A LA LIBERATION COORDONNEE D'AINS (PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDS) | ⤷ Sign Up |
| Norway | 2013014 | ⤷ Sign Up | |
| Brazil | PI0918492 | uso de naproxen, ou sal farmaceuticamente aceitável do mesmo, e esomeprazol, ou sal farmaceuticamente aceitável do mesmo | ⤷ Sign Up |
| Norway | 333836 | ⤷ Sign Up | |
| Australia | 2009200966 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for YOSPRALA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
| 1411900 | 122012000052 | Germany | ⤷ Sign Up | PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | 435 | Finland | ⤷ Sign Up | |
| 1411900 | 91858 | Luxembourg | ⤷ Sign Up | 91858, EXPIRES: 20251105 |
| 1411900 | 1190013-1 | Sweden | ⤷ Sign Up | 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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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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