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Last Updated: October 31, 2024

TYRVAYA Drug Patent Profile


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Which patents cover Tyrvaya, and when can generic versions of Tyrvaya launch?

Tyrvaya is a drug marketed by Oyster Point Pharma and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in nineteen countries.

The generic ingredient in TYRVAYA is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tyrvaya

A generic version of TYRVAYA was approved as varenicline tartrate by ENDO OPERATIONS on August 11th, 2021.

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Summary for TYRVAYA
International Patents:38
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 1
Patent Applications: 132
Drug Prices: Drug price information for TYRVAYA
What excipients (inactive ingredients) are in TYRVAYA?TYRVAYA excipients list
DailyMed Link:TYRVAYA at DailyMed
Drug patent expirations by year for TYRVAYA
Drug Prices for TYRVAYA

See drug prices for TYRVAYA

Recent Clinical Trials for TYRVAYA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Duke UniversityPhase 4

See all TYRVAYA clinical trials

Paragraph IV (Patent) Challenges for TYRVAYA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYRVAYA Nasal Spray varenicline tartrate 0.03 mg/spray 213978 1 2023-04-21

US Patents and Regulatory Information for TYRVAYA

TYRVAYA is protected by ten US patents and one FDA Regulatory Exclusivity.

Patents protecting TYRVAYA

Dry eye treatments
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Methods of increasing lacrimal proteins
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


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Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


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Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Methods of increasing tear production
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Pharmaceutical formulations for treating ocular conditions
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Methods of improving ocular discomfort
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Dry eye treatments
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

FDA Regulatory Exclusivity protecting TYRVAYA

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  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

International Patents for TYRVAYA

See the table below for patents covering TYRVAYA around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 035335 СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ С ПРИМЕНЕНИЕМ ВАРЕНИКЛИНА (METHODS OF TREATING OCULAR DISORDERS USING VARENICLINE) ⤷  Sign Up
Mexico 2017005064 METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.) ⤷  Sign Up
China 111956650 治疗眼部病状的方法 (Methods of treating ocular conditions) ⤷  Sign Up
Japan 7502404 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYRVAYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 08C0039 France ⤷  Sign Up PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
1044189 SPC/GB08/034 United Kingdom ⤷  Sign Up PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
>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.