Yosprala Patent Expiration

Yosprala is a drug owned by Genus Life Sciences Inc. It is protected by 5 US drug patents filed from 2016 to 2018. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2033. Details of Yosprala's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9364439 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US8206741 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Feb, 2023

(1 year, 4 months ago)

Expired
US6926907 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Feb, 2023

(1 year, 4 months ago)

Expired
US9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Jan, 2033

(8 years from now)

Active
US9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Mar, 2033

(8 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Yosprala's patents.

Given below is the list of recent legal activities going on the following patents of Yosprala.

Event Date Patent/Publication
Patent litigations
Maintenance Fee Reminder Mailed 12 Feb, 2024 US8206741
Expire Patent 11 Jul, 2022 US9987231
Maintenance Fee Reminder Mailed 24 Jan, 2022 US9987231
Payment of Maintenance Fee, 4th Year, Large Entity 10 Sep, 2020 US9539214
Surcharge for Late Payment, Large Entity 10 Sep, 2020 US9539214
Maintenance Fee Reminder Mailed 31 Aug, 2020 US9539214
Payment of Maintenance Fee, 8th Year, Large Entity 26 Dec, 2019 US8206741
Email Notification 18 Mar, 2019 US8206741
Change in Power of Attorney (May Include Associate POA) 18 Mar, 2019 US8206741
Email Notification 14 Mar, 2019 US6926907 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Yosprala and ongoing litigations to help you estimate the early arrival of Yosprala generic.

Yosprala's Litigations

Yosprala has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 21, 2015, against patent number US6926907. The petitioner Coalition for Affordable Drugs VII LLC, challenged the validity or infringement of this patent, with POZEN Inc. as the respondent. Click below to track the latest information on how companies are challenging Yosprala's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6926907 May, 2015 Terminated-Denied POZEN Inc. Coalition for Affordable Drugs VII LLC


FDA has granted some exclusivities to Yosprala. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Yosprala, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Yosprala.

Exclusivity Information

Yosprala holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Yosprala's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Sep 14, 2019

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Several oppositions have been filed on Yosprala's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Yosprala's generic, the next section provides detailed information on ongoing and past EP oppositions related to Yosprala patents.

Yosprala's oppositions filed in EPO

Yosprala has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 15, 2011, by Strawman Limited. This opposition was filed on patent number EP02734602A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP02734602A Apr, 2011 CHATFIELD PHARMACEUTICALS LIMITED Patent maintained as amended
EP02734602A Apr, 2011 STRAWMAN LIMITED Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Yosprala is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Yosprala's family patents as well as insights into ongoing legal events on those patents.

Yosprala's family patents

Yosprala has patent protection in a total of 25 countries. It's US patent count contributes only to 39.7% of its total global patent coverage. 12 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Yosprala.

Family Patents

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Generic Launch

Generic Release Date:

Yosprala's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Yosprala Generics:

There are no approved generic versions for Yosprala as of now.

How can I launch a generic of Yosprala before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Yosprala's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Yosprala's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Yosprala -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
81 mg/40 mg and 325 mg/40 mg 14 Oct, 2016 1 28 Feb, 2023 Extinguished




About Yosprala

Yosprala is a drug owned by Genus Life Sciences Inc. It is used for secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers, as well as for the treatment of cardiovascular disease, cardiovascular events, cerebrovascular events, and risk-reduction of aspirin-associated gastric ulcers. Yosprala uses Aspirin; Omeprazole as an active ingredient. Yosprala was launched by Genus Lifesciences in 2016.

Market Authorisation Date:

Yosprala was approved by FDA for market use on 14 September, 2016.

Active Ingredient:

Yosprala uses Aspirin; Omeprazole as the active ingredient. Check out other Drugs and Companies using Aspirin; Omeprazole ingredient

Treatment:

Yosprala is used for secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers, as well as for the treatment of cardiovascular disease, cardiovascular events, cerebrovascular events, and risk-reduction of aspirin-associated gastric ulcers.

Dosage:

Yosprala is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
81MG;40MG TABLET, DELAYED RELEASE Discontinued ORAL
325MG;40MG TABLET, DELAYED RELEASE Discontinued ORAL