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 11^th, 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

Recent Clinical Trials for TYRVAYA

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

Sponsor	Phase
Duke University	Phase 4

See all TYRVAYA clinical trials

Pharmacology for TYRVAYA

Drug Class	Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist
Mechanism of Action	Cholinergic Agonists Partial Cholinergic Nicotinic Agonists

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

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

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

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

FDA Regulatory Exclusivity protecting TYRVAYA

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3209295		⤷ Sign Up
South Korea	102511955		⤷ Sign Up
Singapore	10202011669P	METHODS OF TREATING OCULAR CONDITIONS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TYRVAYA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description