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 six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in TYRVAYA is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-one 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 PAR PHARM INC on August 11^th, 2021.

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Summary for TYRVAYA

International Patents:	34
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	163
Formulation / Manufacturing:	see details
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

Pharmacology for TYRVAYA

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

Anatomical Therapeutic Chemical (ATC) Classes for TYRVAYA

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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 six US patents and one FDA Regulatory Exclusivity.

Patents protecting TYRVAYA

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

Methods of increasing lacrimal proteins
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Methods of increasing tear production
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Pharmaceutical formulations for treating ocular conditions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods of improving ocular discomfort
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

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

FDA Regulatory Exclusivity protecting TYRVAYA

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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
South Korea	102601505		⤷ Try a Trial
European Patent Office	3848028	MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS)	⤷ Try a Trial
Philippines	12017500602	METHODS FOR TREATING OCULAR CONDITIONS	⤷ Try a Trial
Mexico	2017005064	METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.)	⤷ Try a Trial
>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	08C0039	France	⤷ Try a Trial	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	⤷ Try a Trial	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