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 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

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:	191
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

Constraining patent/regulatory exclusivity:

8,058,467

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

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.

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.

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			Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	7,910,767		Y	Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	7,629,345		Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes	7,273,946		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	7,910,767
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	6,211,233
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	7,629,345

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)

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	2004313688	Prostaglandin nitrooxyderivatives
Cyprus	1117417
European Patent Office	3643702	DÉRIVÉS DE PROSTAGLANDINE (PROSTAGLANDIN DERIVATIVES)
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)
Russian Federation	2000100807
Spain	2185188
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)

Market Dynamics and Financial Trajectory for VYZULTA

Introduction

VYZULTA, a prostaglandin F2α analogue, has been a significant player in the treatment of open-angle glaucoma and ocular hypertension since its approval and commercialization. This article delves into the market dynamics and financial trajectory of VYZULTA, highlighting its global reach, clinical efficacy, financial performance, and future outlook.

Global Commercialization and Approval

As of December 31, 2021, VYZULTA was commercialized in 7 territories, including the United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021), and Ukraine (2021)[1]. In addition to these territories, VYZULTA has also been approved in 9 other countries: Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey, and the United Arab Emirates[1].

Clinical Efficacy

VYZULTA has demonstrated strong clinical efficacy in reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The drug's approval was based on two Phase III clinical studies (Study 769 and Study 770), which showed non-inferiority to timolol maleate 0.5% in reducing IOP. These studies also indicated that a significant proportion of patients treated with VYZULTA achieved a mean IOP ≤18 mmHg and a reduction in IOP of ≥25% from baseline[4].

Financial Performance

Revenue and Royalties

Nicox, the company behind VYZULTA, generates revenue primarily through royalties from the drug's sales. Under the exclusive global license agreement with Bausch + Lomb, Nicox receives tiered royalties ranging from 6% to 12% on net global sales of VYZULTA. In 2023, the pharmaceutical segment of Bausch + Lomb, which includes VYZULTA, saw a 54% year-over-year revenue growth for VYZULTA on a constant currency basis[3].

Financial Results

For the first half of 2023, Nicox reported net revenue primarily composed of royalty payments. The company's financial debt as of September 30, 2023, included bond financing and credit agreements, totaling €21.1 million[2]. In the third quarter of 2024, Nicox received no material revenue due to the sale of the VYZULTA royalty, but the company saw a reduction in net loss compared to the same period in 2023, mainly due to increased revenues from other agreements and reduced operating expenses[5].

Market Dynamics

Market Growth and Competition

The ophthalmic market, particularly the segment for glaucoma and ocular hypertension treatments, is competitive but growing. VYZULTA's strong clinical profile and expanding global reach have positioned it as a key player in this market. The drug's performance has been robust, with significant year-over-year growth, which has helped offset challenges in other segments of Bausch + Lomb's pharmaceutical business[3].

Supply Chain and Market Integration

Ensuring consistent product supply remains a priority for Bausch + Lomb, with strategic measures being implemented to mitigate current supply chain volatility. The company's focus on market integration efforts, especially with the acquisition of XIIDRA, positions it for further growth in the ophthalmic market[3].

Future Outlook

Product Launches and Expansion

Bausch + Lomb has ambitious plans for its pharmaceutical and surgical businesses, including the expansion of the enVista lens platform and the integration of new products like MIEBO and XIIDRA. These initiatives are expected to drive future margin expansion and revenue growth[3].

Financial Projections

For 2024, Bausch + Lomb anticipates mid-single-digit market growth, driven by high-margin product launches and the continued success of VYZULTA. The company has raised its revenue guidance, reflecting strong performance in its base business and the contribution from new product integrations[3].

Nicox's Financial Sustainability

Nicox, despite the sale of the VYZULTA royalty, remains financially sustainable into Q3 2025, thanks to the estimated net proceeds from the royalty sale and equity investment. The company's focus on developing new products, such as NCX 470, is crucial for its long-term financial health[5].

Patent and Intellectual Property

Nicox maintains the patents for latanoprostene bunod, the active ingredient in VYZULTA. The U.S. Patent and Trademark Office has determined that three U.S. composition of matter patents covering latanoprostene bunod are eligible for patent term extension, potentially up to 2030. This extension ensures recurrent revenue from VYZULTA in the United States and potentially beyond in other countries[1].

Key Takeaways

• Global Reach: VYZULTA is commercialized in 7 territories and approved in 9 additional countries.
• Clinical Efficacy: Strong clinical data supports VYZULTA's efficacy in reducing IOP.
• Financial Performance: Significant revenue growth driven by VYZULTA's sales, with Nicox receiving tiered royalties.
• Market Dynamics: Competitive market with growing demand, mitigated by supply chain strategies.
• Future Outlook: Positive growth projections driven by new product launches and market integration.

FAQs

What is VYZULTA used for?

VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension[1].

Which company commercializes VYZULTA?

VYZULTA is commercialized by Bausch + Lomb under an exclusive global license agreement with Nicox[1].

How has VYZULTA performed financially?

VYZULTA has seen significant year-over-year revenue growth, contributing to the financial performance of both Nicox and Bausch + Lomb[3].

What are the patent implications for VYZULTA?

The patents for latanoprostene bunod, the active ingredient in VYZULTA, have been extended potentially up to 2030, ensuring continued revenue[1].

What are the future growth prospects for VYZULTA?

Future growth is anticipated through new product launches, market integration efforts, and the continued success of VYZULTA in the ophthalmic market[3].

Sources

1. Nicox Announces VYZULTA Now Commercialized in 7 Territories and Approved in Further 9 Countries - Biospace
2. Nicox Provides First Half 2023 and Third Quarter 2023 Financial Results and Updates Key Milestones - Biospace
3. BLCO Q3-2023 Earnings Call - Alpha Spread
4. Summary Basis of Decision for Vyzulta - Health Canada
5. Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results - GlobeNewswire