Latanoprostene bunod - Generic Drug Details

What are the generic sources for latanoprostene bunod and what is the scope of freedom to operate?

Latanoprostene bunod is the generic ingredient in one branded drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprostene bunod has fifty-three patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for latanoprostene bunod

International Patents:	53
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	6
Patent Applications:	114
What excipients (inactive ingredients) are in latanoprostene bunod?	latanoprostene bunod excipients list
DailyMed Link:	latanoprostene bunod at DailyMed

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

Constraining patent/regulatory exclusivity:

8,058,467

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 latanoprostene bunod

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

Sponsor	Phase
Bausch & Lomb Incorporated	Phase 4
Salus University	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 4

See all latanoprostene bunod clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for latanoprostene bunod

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

Paragraph IV (Patent) Challenges for LATANOPROSTENE BUNOD

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 latanoprostene bunod

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	7,273,946		Y	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	8,058,467			Y

Expired US Patents for latanoprostene bunod

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

International Patents for latanoprostene bunod

Country	Patent Number	Title	Estimated Expiration
Canada	2551409	NITRO-OXY-DERIVES DE LA PROSTAGLANDINE (PROSTAGLANDIN NITROOXYDERIVATIVES)
European Patent Office	3643702	DÉRIVÉS DE PROSTAGLANDINE (PROSTAGLANDIN DERIVATIVES)
Taiwan	200526567	Prostaglandin derivatives
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)
Morocco	28284	Nitro-oxydérivés de prostaglandines

Latanoprostene bunod Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Latanoprostene Bunod

Introduction to Latanoprostene Bunod

Latanoprostene bunod (LBN), marketed as Vyzulta, is a novel prostaglandin F2α analogue that has been approved for the treatment of open-angle glaucoma and ocular hypertension. This drug combines the traditional prostaglandin analogue latanoprost with a nitric oxide (NO)-donating moiety, enhancing its efficacy in reducing intraocular pressure (IOP)[2].

Mechanism of Action and Efficacy

Latanoprostene bunod works by increasing both the uveoscleral and trabecular outflow of aqueous humor, thereby reducing IOP. The NO-donating component enhances the outflow through the trabecular meshwork and Schlemm canal, potentially offering disease-modifying effects[2].

Clinical trials, such as the VOYAGER, APOLLO, and LUNAR studies, have demonstrated that LBN is significantly more effective than traditional prostaglandin analogues like latanoprost and timolol in reducing IOP. For instance, LBN achieved a mean diurnal IOP reduction of 9.0 mm Hg, outperforming latanoprost in several key metrics[2].

Market Need and Demand

The increasing prevalence of glaucoma, particularly with an aging population, drives the demand for effective treatments. The National Eye Institute predicts a 58% increase in glaucoma cases in the United States by 2030, making new pharmacotherapeutics like LBN highly relevant[2].

Competitive Landscape

Latanoprostene bunod enters a market dominated by traditional prostaglandin analogues such as bimatoprost, latanoprost, and travoprost. However, its unique mechanism of action and enhanced efficacy position it favorably. Network meta-analyses have shown that LBN is significantly more effective than unoprostone and most beta-blockers, and it numerically outperforms latanoprost and travoprost while being similar to bimatoprost 0.01% in terms of IOP reduction[1].

Regulatory Approvals and Commercialization

Latanoprostene bunod has received approvals for commercialization in several countries. The drug is marketed by Bausch + Lomb, following a partnership with Nicox, the company that developed the NO-donating technology[2].

Safety and Tolerability

Clinical trials have shown that LBN is well-tolerated, with low rates of hyperemia and discontinuation. The phase 3 registration trials reported a discontinuation rate of about 1.5%, which is remarkably low[2].

Financial Trajectory

The financial trajectory of LBN is influenced by several factors, including its efficacy, safety profile, and market demand.

Revenue Potential

Given its enhanced efficacy and unique mechanism of action, LBN is poised to capture a significant share of the glaucoma treatment market. The increasing prevalence of glaucoma and the need for more effective treatments drive the revenue potential of this drug.

Pricing and Cost Considerations

The cost of LBN will be a critical factor in its adoption. While it may be more expensive than traditional prostaglandin analogues due to its advanced technology, its superior efficacy could justify the higher cost for many patients and healthcare providers[5].

Market Forecast

Market forecasts indicate a positive outlook for LBN. As more clinicians become aware of its benefits and as the patient population grows, the demand for this drug is expected to increase. DelveInsight and other market research firms project significant revenue growth for Vyzulta in the coming years, driven by its unique position in the market and the expanding need for effective glaucoma treatments[4].

Challenges and Opportunities

Challenges

• Regulatory and Safety Concerns: While LBN has shown promising results, it is not without risks. Animal studies have highlighted potential teratogenic effects, which could impact its use in certain patient populations[3].
• Competition: The glaucoma treatment market is highly competitive, with established brands and new entrants vying for market share.

Opportunities

• Expanding Indications: Further research could expand the indications for LBN, potentially including other forms of glaucoma or ocular hypertension.
• Combination Therapies: The possibility of combining LBN with other glaucoma medications could offer additional therapeutic benefits and market opportunities.
• Global Expansion: As approvals are secured in more countries, the global market for LBN is expected to grow.

Key Takeaways

• Enhanced Efficacy: Latanoprostene bunod offers superior IOP reduction compared to many traditional glaucoma medications.
• Unique Mechanism: The NO-donating moiety enhances outflow through the trabecular meshwork and Schlemm canal.
• Market Demand: The increasing prevalence of glaucoma drives demand for effective treatments like LBN.
• Financial Potential: Strong revenue potential due to its efficacy and growing market need.
• Safety and Tolerability: Well-tolerated with low discontinuation rates.

FAQs

1. What is the mechanism of action of latanoprostene bunod?

   • Latanoprostene bunod increases both the uveoscleral and trabecular outflow of aqueous humor by combining a traditional prostaglandin analogue with a nitric oxide (NO)-donating moiety[2].

2. How does latanoprostene bunod compare to traditional prostaglandin analogues?

   • It is significantly more effective than unoprostone and most beta-blockers, and numerically outperforms latanoprost and travoprost while being similar to bimatoprost 0.01% in terms of IOP reduction[1].

3. What are the safety concerns associated with latanoprostene bunod?

   • Animal studies have shown potential teratogenic effects, and there are no data on its presence in human milk or its effects on the breastfed infant[3].

4. Who are the key players involved in the commercialization of latanoprostene bunod?

   • Bausch + Lomb, in partnership with Nicox, is responsible for the commercialization of Vyzulta (latanoprostene bunod)[2].

5. What is the projected market growth for latanoprostene bunod?

   • Market forecasts indicate significant revenue growth driven by its unique position in the market and the expanding need for effective glaucoma treatments[4].

Sources

1. Systematic Literature Review and Network Meta-Analysis: "Comparative efficacy of latanoprostene bunod and other medications for open-angle glaucoma and ocular hypertension" - British Journal of Ophthalmology[1].
2. New Pharmacotherapeutics for Glaucoma: "Latanoprostene bunod and netarsudil have unique and interesting MOAs" - Modern Optometry[2].
3. The Innovators - The Ophthalmologist: "Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits" - The Ophthalmologist[3].
4. Vyzulta (Latanoprostene Bunod Ophthalmic Solution) Drug Insight: "Market forecast and pharmacological studies" - DelveInsight[4].
5. Practical Guidelines for Effective Glaucoma Therapy: "Financial Disclosure Prostaglandin Analogs (PGs)" - Vision Expo East[5].