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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9539214 | Compositions and methods for delivery of omeprazole plus acetylsalicylic acid | 
                          Mar, 2033
                           (7 years from now) | Active   | 
| US9987231 | Compositions and methods for delivery of omeprazole plus acetylsalicylic acid | 
                          Jan, 2033
                           (7 years from now) | Active   | 
| US8206741 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | 
                          Feb, 2023
                           (2 years ago) | 
                          Expired
                         | 
| US6926907 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | 
                          Feb, 2023
                           (2 years ago) | 
                          Expired
                         | 
| US9364439 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | 
                          May, 2022
                           (3 years ago) | 
                          Expired
                         | 
                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.
                
Latest Legal Activities on Yosprala's Patents
Given below is the list of recent legal activities going on the following patents of Yosprala.
| Activity | Date | Patent Number | 
|---|---|---|
|   | ||
| Maintenance Fee Reminder Mailed 
                              Critical | 12 Feb, 2024 | US8206741 | 
| Expire Patent 
                              Critical | 11 Jul, 2022 | US9987231 | 
| Maintenance Fee Reminder Mailed 
                              Critical | 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 
                              Critical | 31 Aug, 2020 | US9539214 | 
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Dec, 2019 | US8206741 | 
| Email Notification 
                              Critical | 18 Mar, 2019 | US8206741 | 
| Change in Power of Attorney (May Include Associate POA) 
                              Critical | 18 Mar, 2019 | US8206741 | 
| Email Notification 
                              Critical | 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 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 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 | 
|---|---|---|---|---|
|   | ||||
| US6926907 | May, 2015 | Institution Denied (08 Dec, 2015) | POZEN Inc. et al. | Coalition for Affordable Drugs VII LLC et al. | 
| US6926907 | May, 2015 | Terminated-Denied (08 Dec, 2015) | 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 | 
                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 | 
|---|---|---|---|
|   | |||
| 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
 
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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.
Approval 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 | 
|---|---|---|---|
| 325MG;40MG | TABLET, DELAYED RELEASE | Discontinued | ORAL | 
| 81MG;40MG | TABLET, DELAYED RELEASE | Discontinued | ORAL | 
 
 