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VYZULTA Drug Patent Profile

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When do Vyzulta patents expire, and what generic alternatives are available?

Vyzulta is a drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in VYZULTA is latanoprostene bunod. One supplier is listed for this compound. Additional details are available on the latanoprostene bunod profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyzulta

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 21, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for VYZULTA

International Patents:	53
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	2
Patent Applications:	45
Drug Prices:	Drug price information for VYZULTA
What excipients (inactive ingredients) are in VYZULTA?	VYZULTA excipients list
DailyMed Link:	VYZULTA at DailyMed

Drug patent expirations by year for VYZULTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VYZULTA

Generic Entry Date for VYZULTA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 207795 Dosage: SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VYZULTA

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

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	Phase 4
Bausch & Lomb Incorporated	N/A
University of California, San Diego	N/A

See all VYZULTA clinical trials

Paragraph IV (Patent) Challenges for VYZULTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYZULTA	Ophthalmic Solution	latanoprostene bunod	0.024%	207795	1	2022-03-31

US Patents and Regulatory Information for VYZULTA

VYZULTA is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYZULTA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYZULTA

Prostaglandin derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

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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
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for VYZULTA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VYZULTA

When does loss-of-exclusivity occur for VYZULTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Intellectual Property Organization (OAPI)

Patent: 356
Patent: Prostaglandin nitrooxyderivatives.
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VYZULTA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	4394170		⤷ Sign Up
Portugal	989972		⤷ Sign Up
South Korea	20060113753	PROSTAGLANDIN NITROOXYDERIVATIVES	⤷ Sign Up
Hong Kong	1096084	PROSTAGLANDIN NITROOXYDERIVATIVES	⤷ Sign Up
Japan	2002506440		⤷ Sign Up
Israel	176416	תולדות פרוסטגלנדין ניטרואוקסי, תכשירים רוקחיים המכילים אותן, והשימוש בהן להכנת התרופה לטיפול בגלוקומה או לחץ תוך-עיני (Prostaglandin nitrooxy derivatives, pharmaceutical compositions comprising the same and use thereof in the preparation of medicaments for treating glaucoma or ocular hypertension)	⤷ Sign Up
Hungary	0004071		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration