Tyrvaya is a drug owned by Oyster Point Pharma Inc. It is protected by 10 US drug patents filed from 2021 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 19, 2035. Details of Tyrvaya'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). | |||
| US11224598 | Methods of increasing lacrimal proteins |
Oct, 2035
(10 years from now) | Active |
| US10456396 | Dry eye treatments |
Oct, 2035
(10 years from now) | Active |
| US9597284 | Dry eye treatments |
Oct, 2035
(10 years from now) | Active |
| US9532944 | Methods of improving ocular discomfort |
Oct, 2035
(10 years from now) | Active |
| US9504644 | Methods of increasing tear production |
Oct, 2035
(10 years from now) | Active |
| US11911380 | Compositions and use of varenicline for treating dry eye |
Oct, 2035
(10 years from now) | Active |
| US11903943 | Compositions and use of varenicline for treating dry eye |
Oct, 2035
(10 years from now) | Active |
| US11903941 | Compositions and use of varenicline for treating dry eye |
Oct, 2035
(10 years from now) | Active |
| US9504645 | Pharmaceutical formulations for treating ocular conditions |
Oct, 2035
(10 years from now) | Active |
| US11903942 | Compositions and use of varenicline for treating dry eye |
Oct, 2035
(10 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 Tyrvaya's patents.
Latest Legal Activities on Tyrvaya's Patents
Given below is the list of recent legal activities going on the following patents of Tyrvaya.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jun, 2024 | US9532944 |
| Patent eCofC Notification | 04 Jun, 2024 | US11903942 |
| Email Notification Critical | 04 Jun, 2024 | US11903942 |
| Recordation of Patent eCertificate of Correction | 04 Jun, 2024 | US11903942 |
| Mail Patent eCofC Notification | 04 Jun, 2024 | US11903942 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 May, 2024 | US9504645 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 May, 2024 | US9504644 |
| Post Issue Communication - Certificate of Correction | 15 May, 2024 | US11903942 |
| Patent eGrant Notification | 27 Feb, 2024 | US11911380 |
| Mail Patent eGrant Notification | 27 Feb, 2024 | US11911380 |
FDA has granted several exclusivities to Tyrvaya. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tyrvaya, 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 Tyrvaya.
Exclusivity Information
Tyrvaya holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Tyrvaya's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 15, 2024 |
Several oppositions have been filed on Tyrvaya'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 Tyrvaya's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tyrvaya patents.
Tyrvaya's Oppositions Filed in EPO
Tyrvaya has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 09, 2021, by Beck Greener Llp. This opposition was filed on patent number EP15852340A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15852340A | Sep, 2021 | Beck Greener LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tyrvaya 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 Tyrvaya's family patents as well as insights into ongoing legal events on those patents.
Tyrvaya's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tyrvaya's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 19, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tyrvaya Generic API suppliers:
Varenicline Tartrate is the generic name for the brand Tyrvaya. 18 different companies have already filed for the generic of Tyrvaya, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tyrvaya's generic
How can I launch a generic of Tyrvaya before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tyrvaya's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tyrvaya'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 Tyrvaya -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.03 mg/spray | 21 Apr, 2023 | 1 | 19 Oct, 2035 |
Alternative Brands for Tyrvaya
Tyrvaya which is used for treating dry eye disease symptoms., has several other brand drugs in the same treatment category and using the same active ingredient (Varenicline Tartrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Varenicline Tartrate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Pf Prism Cv |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Varenicline Tartrate, Tyrvaya's active ingredient. Check the complete list of approved generic manufacturers for Tyrvaya
About Tyrvaya
Tyrvaya is a drug owned by Oyster Point Pharma Inc. It is used for treating dry eye disease symptoms. Tyrvaya uses Varenicline Tartrate as an active ingredient. Tyrvaya was launched by Oyster Point Pharma in 2021.
Approval Date:
Tyrvaya was approved by FDA for market use on 15 October, 2021.
Active Ingredient:
Tyrvaya uses Varenicline Tartrate as the active ingredient. Check out other Drugs and Companies using Varenicline Tartrate ingredient
Treatment:
Tyrvaya is used for treating dry eye disease symptoms.
Dosage:
Tyrvaya is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.03MG BASE/SPRAY | SPRAY | Prescription | NASAL |