Tyrvaya Patent Expiration

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.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jun, 2024 US9532944
Patent eCofC Notification 04 Jun, 2024 US11903942
Email Notification 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

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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
Patent litigations
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

Tyrvaya has patent protection in a total of 17 countries. It's US patent count contributes only to 28.6% of its total global patent coverage. Click below to unlock the full patent family tree for Tyrvaya.

Family Patents

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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. 15 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.

Drug Owner Drug Name Treatment Area
Bausch And Lomb Inc
Miebo Used for managing dry eye disease symptoms.
Xiidra Used for relieving symptoms of dry eye disease.
Harrow Eye
Vevye Used for managing symptoms of dry eye disease.

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
Chantix


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