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 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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Questions you can ask:
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
Icahn School of Medicine at Mount Sinai | Phase 4 |
University of California, San Diego | N/A |
Bausch & Lomb Incorporated | N/A |
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 ⤷ Subscribe.
This potential generic entry date is based on patent 8,058,467.
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: 7,273,946
Patent Expiration: ⤷ Subscribe
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Prostaglandin derivatives
Patent Number: 7,629,345
Patent Expiration: ⤷ Subscribe
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Prostaglandin derivatives
Patent Number: 7,910,767
Patent Expiration: ⤷ Subscribe
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Prostaglandin derivatives
Patent Number: 8,058,467
Patent Expiration: ⤷ Subscribe
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 | 8,058,467 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Bausch And Lomb | VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795-001 | Nov 2, 2017 | RX | Yes | Yes | 7,910,767 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Bausch And Lomb | VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795-001 | Nov 2, 2017 | RX | Yes | Yes | 7,629,345 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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
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 | 6,211,233 | ⤷ Subscribe |
>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: ⤷ Subscribe
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 |
---|---|---|---|
South Korea | 100850133 | ⤷ Subscribe | |
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) | ⤷ Subscribe |
Hong Kong | 1096084 | PROSTAGLANDIN NITROOXYDERIVATIVES | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |