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Last Updated: June 27, 2022

VYZULTA Drug Patent Profile


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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

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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: 14
Clinical Trials: 2
Patent Applications: 74
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
Drug Prices for VYZULTA

See drug prices for VYZULTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VYZULTA
Generic Entry Date for VYZULTA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 4
University of California, San DiegoN/A
Bausch & Lomb IncorporatedN/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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

Prostaglandin derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

Prostaglandin derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

Prostaglandin derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 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
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 7081
Estimated Expiration: See Plans and Pricing

Patent: 8931
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04313688
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0418245
Estimated Expiration: See Plans and Pricing

Canada

Patent: 51409
Estimated Expiration: See Plans and Pricing

China

Patent: 06159
Estimated Expiration: See Plans and Pricing

Patent: 0469765
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 98
Estimated Expiration: See Plans and Pricing

Patent: 110131
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160500
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17417
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 04141
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066684
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0595
Estimated Expiration: See Plans and Pricing

Patent: 0601099
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 04141
Estimated Expiration: See Plans and Pricing

Patent: 02277
Estimated Expiration: See Plans and Pricing

Patent: 43702
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0094780
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0500293
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 96084
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27357
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6416
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84283
Estimated Expiration: See Plans and Pricing

Patent: 07518716
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7181
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06007678
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 433
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 284
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8271
Estimated Expiration: See Plans and Pricing

Norway

Patent: 7217
Estimated Expiration: See Plans and Pricing

Patent: 9685
Estimated Expiration: See Plans and Pricing

Patent: 063567
Estimated Expiration: See Plans and Pricing

Patent: 151341
Estimated Expiration: See Plans and Pricing

Panama

Patent: 20901
Estimated Expiration: See Plans and Pricing

Peru

Patent: 051052
Estimated Expiration: See Plans and Pricing

Poland

Patent: 04141
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 717
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 04141
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0605354
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0850133
Estimated Expiration: See Plans and Pricing

Patent: 0854838
Estimated Expiration: See Plans and Pricing

Patent: 060113753
Estimated Expiration: See Plans and Pricing

Patent: 080007415
Estimated Expiration: See Plans and Pricing

Spain

Patent: 66800
Estimated Expiration: See Plans and Pricing

Patent: 67136
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 37994
Estimated Expiration: See Plans and Pricing

Patent: 0526567
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 06210
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 726
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 709
Estimated Expiration: See Plans and Pricing

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
Australia 740683 See Plans and Pricing
Taiwan 200526567 Prostaglandin derivatives See Plans and Pricing
Uruguay 28709 DERIVADOS DE PROSTAGLANDINAS See Plans and Pricing
African Intellectual Property Organization (OAPI) 13356 Prostaglandin nitrooxyderivatives. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.