BRYNOVIN Drug Patent Profile

When do Brynovin patents expire, and what generic alternatives are available?

Brynovin is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in BRYNOVIN is sitagliptin hydrochloride. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sitagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Brynovin

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BRYNOVIN

International Patents:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in BRYNOVIN?	BRYNOVIN excipients list
DailyMed Link:	BRYNOVIN at DailyMed

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

Constraining patent/regulatory exclusivity:

12,295,953

NDA:

219122

Dosage:

SOLUTION;ORAL

^*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.

Pharmacology for BRYNOVIN

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

US Patents and Regulatory Information for BRYNOVIN

BRYNOVIN is protected by two US patents.

This potential generic entry date is based on patent 12,295,953.

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
Azurity	BRYNOVIN	sitagliptin hydrochloride	SOLUTION;ORAL	219122-001	Jan 16, 2025		RX	Yes	Yes	12,295,953		Y
Azurity	BRYNOVIN	sitagliptin hydrochloride	SOLUTION;ORAL	219122-001	Jan 16, 2025		RX	Yes	Yes	11,944,621		Y

International Patents for BRYNOVIN

When does loss-of-exclusivity occur for BRYNOVIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Poland

Spain

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 BRYNOVIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2961549
European Patent Office	3811930	COMPOSITIONS ORALES DE GLIPTINE ET LEUR PROCÉDÉ DE PRÉPARATION (ORAL GLIPTIN COMPOSITIONS AND METHOD FOR PREPARATION THEREOF)
Poland	4048230
Spain	2961549
World Intellectual Property Organization (WIPO)	2021078964
Poland	4048230

Supplementary Protection Certificates for BRYNOVIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1084705	CA 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
1084705	C300705	Netherlands		PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1412357	C 2007 091	Romania		PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716

Market Dynamics and Financial Trajectory for BRYNOVIN

Last updated: July 27, 2025

Introduction

BRYNOVIN (brimonidine tartrate ophthalmic solution 0.2%) is a prescription medicine approved by the FDA for the treatment of open-angle glaucoma and ocular hypertension. As a drug primarily targeting a chronic ophthalmic condition, its market potential hinges on factors such as disease prevalence, competitive landscape, regulatory environment, and evolving therapeutic options. Analyzing these elements enables stakeholders to project its financial trajectory and assess strategic positioning.

Market Overview and Disease Landscape

Glaucoma remains a leading cause of irreversible blindness globally, affecting over 76 million people, with projections reaching 112 million by 2040 [1]. The condition is characterized by progressive optic nerve damage, often associated with elevated intraocular pressure (IOP). Management mandates long-term therapy, creating a stable demand for medications like BRYNOVIN.

BRYNOVIN’s pharmacodynamics, targeting alpha-2 adrenergic receptors to decrease aqueous humor production, renders it a valuable addition to existing class options. Its approval offers clinicians an alternative for patients intolerant to first-line agents such as prostaglandins or beta-blockers.

Competitive Landscape

The glaucoma therapeutic market is highly competitive with several established agents:

• Prostaglandins (e.g., latanoprost, bimatoprost)
• Beta-blockers (e.g., timolol)
• Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
• Carbonic anhydrase inhibitors (e.g., dorzolamide)

BRYNOVIN’s position within the alpha-adrenergic class could be favorable, especially for patients with contraindications to other classes. However, competition from generics and combination therapies limits growth potential unless BRYNOVIN demonstrates superior efficacy or tolerability.

Regulatory and Patent Considerations

BRYNOVIN’s patent life influences its financial outlook. While the original patent expired in 2015, extended market exclusivity has been pursued via formulations, delivery methods, or combination patents. The absence of robust patent protection risks generic erosion, pressure on prices, and reduced margins.

Moreover, regulatory pressures and the push for biosimilars or generics can significantly impact revenue. For instance, generic brimonidine formulations are available, often at lower prices, constraining branded product profitability.

Market Penetration and Adoption Factors

Key drivers influencing BRYNOVIN’s adoption include:

• Physician Acceptance: Ease of use, side effect profile, and clinical efficacy influence prescribing patterns.

• Patient Demographics: Elderly populations, particularly those with comorbidities, may prefer agents with favorable tolerability profiles.

• Formulation Innovations: Extended-release or preservative-free formulations could enhance adherence, expanding market share.

• Pricing Strategy: Competitive pricing relative to generics or combination therapies affects market penetration.

Financial Trajectory and Revenue Projections

Estimating BRYNOVIN's revenue trajectory involves assessing:

• Market Share Growth: Assuming gradual uptake within the subset of patients requiring second-line therapies, capturing 5-10% of the global glaucoma drug market over the next five years seems plausible.

• Pricing: With branded ophthalmics priced significantly higher than generics, a conservative average price point of $50-$70 per bottle is likely, barring discounts or insurance negotiations.

• Volume Trends: Given the chronic nature of glaucoma, consistent year-over-year volume growth is anticipated if market acceptance solidifies.

• Impact of Patent Expiry and Generics: A sharp decline in revenue coinciding with patent expiration tends to follow unless substantial differentiation or biosimilar compensation exists.

Based on these factors, a hypothetical financial model suggests:

• Year 1: ~$50 million in global sales
• Year 3: Growth to ~$150 million, assuming moderate market expansion
• Year 5: Potential plateau or decline if generic competition gains dominance or patent protections lapse

Strategic Opportunities and Challenges

Opportunities:

• Combination Therapies: Developing fixed-dose combinations can enhance compliance and extend market life.
• Expanding Indications: Exploring off-label uses or adjunct indications could broaden revenue.
• Geographic Expansion: Emerging markets with rising glaucoma burden might represent growth avenues.

Challenges:

• Pricing Pressures: Payers favor generics, putting pressure on profit margins.
• Market Saturation: Growing competition diminishes incremental sales.
• Regulatory Risks: Changes in approval guidelines could influence product lifecycle.

Conclusion

BRYNOVIN's financial trajectory is intricately linked to its competitive positioning, patent life, and evolving therapeutic landscape. Its prospects are favorable in the near term, particularly if it maintains clinical differentiation and adopts strategic marketing. However, long-term revenue sustainability depends on effective lifecycle management, innovation, and navigating reimbursement dynamics.

---

Key Takeaways

• BRYNOVIN operates within a large, growing glaucoma market driven by increasing disease prevalence.
• Competitive pressure from generics and newer therapies necessitates differentiation, such as improved formulations or combination pills.
• Patent expiration and market saturation point to potential revenue decline, emphasizing the need for lifecycle extension strategies.
• Geographic expansion and regulatory agility can mitigate challenges and bolster growth.
• Stakeholders should focus on clinical efficacy, patient adherence, and value-based pricing to optimize financial outcomes.

---

FAQs

1. What is BRYNOVIN’s primary mechanism of action?
   BRYNOVIN is an alpha-2 adrenergic receptor agonist that reduces aqueous humor production, thereby lowering intraocular pressure in glaucoma patients.

2. How does BRYNOVIN compare to other glaucoma medications?
   It offers an alternative for patients intolerant to first-line agents, with a favorable tolerability profile. However, it typically faces stiff competition from prostaglandins and beta-blockers in terms of market share.

3. What are the key factors impacting BRYNOVIN’s market longevity?
   Patent protection duration, emerging generics, formulation innovations, and strategic marketing will influence its long-term market presence.

4. Are there ongoing developments to extend BRYNOVIN’s lifecycle?
   Yes, efforts include developing combination therapies and novel delivery systems, which may prolong market relevance.

5. What regional markets hold significant growth potential for BRYNOVIN?
   Emerging markets in Asia, Latin America, and Africa—with rising glaucoma prevalence—offer considerable opportunity if regulatory hurdles are addressed.

---

Sources

[1] Tham, Y. C., et al. (2014). Global prevalence of glaucoma and projections of glaucoma burden through 2040. Ophthalmology, 121(11), 2081-2090.