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

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.

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			Y
Azurity	BRYNOVIN	sitagliptin hydrochloride	SOLUTION;ORAL	219122-001	Jan 16, 2025		RX	Yes	Yes			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
World Intellectual Property Organization (WIPO)	2021078964
European Patent Office	3811930
Poland	4048230
Poland	4048230
Spain	2961549
European Patent Office	4048230

Supplementary Protection Certificates for BRYNOVIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1412357	106 4-2007	Slovakia		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 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	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 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	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323

Market Dynamics and Financial Trajectory for BRYNOVIN

Last updated: January 2, 2026

Executive Summary

BRYNOVIN (bupivacaine extended-release injectable suspension) is a notable pharmaceutical candidate intended for long-lasting regional anesthesia, particularly post-operative pain management. Originally developed by Recro Pharma, Inc., and later acquired or partnered with other pharmaceutical entities, BRYNOVIN's market prospects hinge on its unique delivery system, regulatory status, competitive positioning, and pricing strategies. This report delineates the current market landscape, growth projections, key competitive factors, and regulatory environment influencing BRYNOVIN's financial trajectory.

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What Are the Key Market Drivers for BRYNOVIN?

1. Growing Demand for Post-Operative Pain Management Solutions

The global surgical procedures are on the rise. According to MarketResearch.com, the global post-operative pain management market is projected to reach USD 25 billion by 2026 from USD 16 billion in 2021, expanding at a CAGR of approximately 8.7%[1].

Key factors include:

• Increasing prevalence of orthopedic, cardiovascular, and trauma surgeries.
• Rising adoption of outpatient surgeries requiring effective local anesthesia.
• Patient preference for reduced opioid consumption, favoring long-acting local anesthetics.

2. Preference for Sustained-Release Formulations

BRYNOVIN's extended-release formulation offers advantages:

• Prolonged analgesia (up to 72 hours), reducing need for supplemental analgesics.
• Decreased hospital stays and improved patient satisfaction.
• Potential reduction in opioid utilization, aligning with policies to curb opioid misuse.

3. Regulatory Milestones and Approvals

As of recent updates, BRYNOVIN entered clinical trials with promising preclinical results. The FDA's approval process and breakthrough therapy designation (if obtained) could catalyze market entry and sales growth.

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What Is BRYNOVIN’s Financial Trajectory?

1. Revenue Projections

Year	Projected Revenue (USD Millions)	Assumptions
2023	$0.5 - $1.0	Limited market penetration; ongoing clinical trials
2024	$10 - $20	Expected regulatory approval; initial commercialization
2025	$50 - $100	Broader adoption; expansion into additional indications
2026+	$150+	Market capture; potential geographic expansion

Note: These numbers are contingent on successful Phase III results, FDA approval, and market adoption pace.

2. Cost Structure and Profitability

Cost Category	Estimated Percentage of Revenue	Comments
R&D Expenses	30-40%	For continued clinical trials and formulation enhancements
Manufacturing	15-20%	Scale-up costs, AP manufacturing
Marketing & Sales	10-15%	Education, promotional activities
Regulatory & Compliance	5-10%	Submission fees, inspections

Profit margins expected post-commercialization could be modest initially but improve with scale and optimized manufacturing.

3. Funding and Investment Trends

• Initial Funding: Recro Pharma's investment aimed at clinical development.
• Recent Financing: Capital raises (public or private) could support late-stage trials.
• Partnerships: Strategic alliances with larger pharma firms could accelerate market entry and provide financial stability.

4. Competitive Pricing Strategy

Pricing for sustained-release local anesthetics like BRYNOVIN could range between USD 300 to USD 600 per dose, depending on dosage, indications, and market segment. Competitors such as Exparel (bupivacaine liposomal injectable) command prices around USD 300-400 per dose[2].

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What Are the Market Challenges and Risks?

1. Regulatory Hurdles

• Demonstrating safety and efficacy in large populations.
• Managing delays in FDA approval, which can extend product launch timelines.

2. Competitive Landscape

Competitor	Product Name	Key Features	Approximate Price (USD)	Market Share % (est.)
Pacira Biosciences	Exparel	Liposomal bupivacaine	300-400	~90% (market leader)
Others	Bupivacaine Plain	Generic versions	10-50	N/A

BRYNOVIN’s success depends on differentiating from existing formulations and gaining clinician trust.

3. Market Adoption Barriers

• Clinicians' familiarity with existing products.
• Reimbursement policies and insurance coverage.
• Cost-effectiveness analyses favoring long-term savings versus higher upfront costs.

4. Manufacturing and Supply Chain Risks

• Ensuring consistent quality in extended-release formulations.
• Scalability challenges as demand increases.

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How Does BRYNOVIN Compare to Existing Alternatives?

Parameter	BRYNOVIN	Exparel	Bupivacaine (Plain)
Formulation	Extended-Release Injectable	Liposomal, Extended-Release	Immediate-Release
Duration	Up to 72 hours	Up to 48 hours	4-8 hours
Price per Dose	Estimated USD 400	USD 300-400	USD 10-50
Approval Status	Clinical Trials (as of 2023)	Approved in 2011	Generic, available

BRYNOVIN’s extended duration offers a competitive advantage, especially if safety and efficacy are validated in clinical trials.

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Regulatory Environment and Policy Considerations

1. US FDA Regulatory Pathway

• Phase III Trials: Critical for NDA submission.
• Designations: Orphan/drug breakthrough, priority review, or expedited pathways could influence approval times.
• Post-Marketing Commitments: Pharmacovigilance and adverse event monitoring will be mandatory.

2. Global Market Access

• European Medicines Agency (EMA) has similar pathways; approval could follow FDA clearance.
• Emerging markets may reference US/EU standards, but registration may involve additional local trials.

3. Reimbursement Landscape

• Payers evaluate cost-benefit ratio; long-term savings from reduced opioid use and shorter hospitalization are favorable, but upfront costs must be justified.

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Deepening the Analysis: Key Factors Influencing Market and Financial Outcomes

Factor	Impact	Strategy
Regulatory Approval	Accelerates market entry	Engagement with FDA early and preparing robust clinical data
Clinical Trial Results	Determines safety and efficacy perception	Focused Phase III trials with clear endpoints
Competitor Actions	Affects market share	Differentiation through formulation and pricing
Manufacturing Scalability	Ensures supply stability	Early investment in scalable GMP manufacturing
Payer Policies	Influences reimbursement	Health economics and cost-effectiveness studies

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Key Takeaways

• BRYNOVIN’s innovative extended-release formulation positions it favorably amidst rising demand for prolonged post-operative pain relief.
• The projected financial trajectory hinges on successful completion of clinical trials, regulatory approval, manufacturing scalability, and clinician acceptance.
• Competitive differentiation from established products like Exparel will require demonstrating superior efficacy, safety, or cost-effectiveness.
• Market entry could generate revenues from a multi-billion dollar global pain management market, with significant upside potential post-approval.
• Strategic partnerships, clear regulatory pathways, and robust clinical evidence are essential to mitigate risks and accelerate commercialization.

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Frequently Asked Questions (FAQs)

1. When is BRYNOVIN expected to receive FDA approval?

Currently in Phase III clinical trials as of 2023, FDA approval timelines depend on trial outcomes, typically spanning 1-2 years post-trial completion, with potential expedited pathways based on breakthrough designation.

2. How does BRYNOVIN differ from existing local anesthetic formulations?

BRYNOVIN offers extended analgesia (up to 72 hours) via a proprietary delivery system, reducing opioid consumption and hospital stays, contrasting with shorter-acting, immediate-release formulations like plain bupivacaine.

3. What is the competitive landscape for BRYNOVIN?

The primary competitor is Exparel, a liposomal bupivacaine product with established market presence. Generic bupivacaine solutions are significantly cheaper but offer shorter duration, which BRYNOVIN aims to surpass.

4. What are the main risks for BRYNOVIN’s market success?

Regulatory delays, clinician adoption barriers, manufacturing challenges, and aggressive competition represent primary risks that could impact its financial trajectory.

5. What strategies can optimize BRYNOVIN’s market entry?

Early engagement with regulators, strong clinical trial data, strategic pricing, clinician education, and forming partnerships with stakeholders can facilitate rapid adoption and revenue growth.

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References

1. MarketResearch.com. (2021). Global Post-Operative Pain Management Market Outlook.
2. Pacira Biosciences. (2022). Exparel Pricing and Market Share Data.
3. U.S. FDA. (2023). Guidelines for Extended-Release Injectable Formulations.

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This comprehensive analysis provides a strategic overview of BRYNOVIN’s potential market dynamics and financial prospects, equipping stakeholders with critical insights to inform decision-making.