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 |
Recent Clinical Trials for TYRVAYA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Duke University | Phase 4 |
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
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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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
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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Patent Expiration: ⤷ Sign Up
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 |