VYZULTA Drug Patent Profile

When do Vyzulta patents expire, and when can generic versions of Vyzulta launch?

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 October 3, 2025. 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

Summary for VYZULTA

International Patents:	53
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	72
Drug Prices:	Drug price information for VYZULTA
What excipients (inactive ingredients) are in VYZULTA?	VYZULTA excipients list
DailyMed Link:	VYZULTA at DailyMed

See drug prices for VYZULTA

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

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
University of California, San Diego	N/A
Bausch & Lomb Incorporated	N/A

See all VYZULTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VYZULTA

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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.

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

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				Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes			Y	Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes			Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes			Y	Y

Expired US Patents for VYZULTA

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

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)

Argentina

Australia

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Guatemala

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Panama

Peru

Poland

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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.

Country	Patent Number	Title	Estimated Expiration
Guatemala	200500293	DERIVADOS DE PROSTAGLANDINAS
Cyprus	1117417
Ukraine	84726	ПРОИЗВОДНЫЕ ПРОСТАГЛАНДИНОВ, СПОСОБ ИХ ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ ГЛАУКОМЫ ИЛИ ГИПЕРТЕНЗИИ ГЛАЗА;ПОХІДНІ ПРОСТАГЛАНДИНІВ, СПОСІБ ЇХ ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ ГЛАУКОМИ АБО ГІПЕРТЕНЗІЇ ОКА (PROSTAGLANDIN DERIVATIVES, PROCESS FOR THE PREPARATION THEREOF, PHARMACEUTICAL COMPOSITION (VARIANTS) AND METHOD FOR THE TREATMENT OF GLAUCOMA AND OCULAR HYPERTENSION)
European Patent Office	1704141	DERIVES NITROOXY DE PROSTAGLANDINES (PROSTAGLANDIN NITROOXYDERIVATIVES)
Norway	20151341	Prostaglandinnitrooksyderivater