NUVESSA Drug Patent Profile

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

Nuvessa is a drug marketed by Chemo Research Sl and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in nine countries.

The generic ingredient in NUVESSA is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuvessa

A generic version of NUVESSA was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for NUVESSA

International Patents:	16
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	172
Patent Applications:	3,618
What excipients (inactive ingredients) are in NUVESSA?	NUVESSA excipients list
DailyMed Link:	NUVESSA at DailyMed

Pharmacology for NUVESSA

Drug Class

Nitroimidazole Antimicrobial

Paragraph IV (Patent) Challenges for NUVESSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVESSA	Vaginal Gel	metronidazole	1.30%	205223	1	2022-03-30

US Patents and Regulatory Information for NUVESSA

NUVESSA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	9,198,858
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	10,596,155		Y
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	7,893,097		Y
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	8,658,678
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	8,946,276

International Patents for NUVESSA

See the table below for patents covering NUVESSA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2014518272
European Patent Office	2725904	FORMULATIONS DE GEL À BASE DE MÉTRONIDAZOLE AQUEUX MUCOADHÉSIF À DOSAGE ÉLEVÉ ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTÉRIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS)
World Intellectual Property Organization (WIPO)	2009097143
Japan	6235087
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana

Supplementary Protection Certificates for NUVESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

NUVESSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nuvessa

Introduction

Nuvessa, a metronidazole vaginal gel, is a significant player in the women's health market, specifically targeting the treatment of bacterial vaginosis (BV). To understand its market dynamics and financial trajectory, it is crucial to delve into its approval history, market positioning, and the challenges it faces.

Approval History and Indications

Nuvessa was approved by the FDA on March 24, 2014, for the treatment of bacterial vaginosis in nonpregnant women. The approval was based on clinical trials that demonstrated its efficacy in this population[3].

Expansion to Adolescent Population

In 2018, the FDA reviewed and approved an efficacy supplement to include females aged 12 to less than 18 years, following a post-marketing requirement (PMR) study that evaluated the safety of Nuvessa in this age group[3].

Market Positioning

Unmet Needs in Women's Health

The women's health market, particularly in the areas of vaginal health and bacterial vaginosis, presents several unmet needs. Nuvessa addresses one of these needs by providing an effective treatment for BV, a common condition that can lead to significant discomfort and health complications[4].

Competitive Landscape

The market for BV treatments is competitive, with various products available. However, Nuvessa's unique formulation as a vaginal gel sets it apart. It is designed to provide targeted treatment with minimal systemic absorption, which can be advantageous for patients seeking localized therapy[2].

Financial Trajectory

Revenue Streams

The financial trajectory of Nuvessa is influenced by several factors, including sales revenue, royalty payments, and milestone payments from licensing agreements. Daré Bioscience, the company behind Nuvessa, generates revenue through the commercialization of its products and collaborations with other pharmaceutical companies[1].

Challenges in Revenue Generation

Despite its approval and market positioning, Nuvessa faces several challenges that can impact its revenue:

• Regulatory Hurdles: Changes in regulatory requirements or FDA determinations can significantly affect the product's approval timeline and commercial success[1].
• Market Acceptance: The degree of market acceptance and adoption by healthcare providers and patients is crucial. Factors such as coverage and reimbursement by health insurance programs also play a significant role[1].
• Competition: The presence of generic products and other branded treatments in the market can make it challenging to maintain market share and pricing[1].

Cost and Pricing

The cost of developing and commercializing Nuvessa is substantial. Daré Bioscience incurs expenses related to clinical trials, manufacturing, and marketing. The pricing strategy must balance the need for profitability with the need to remain competitive in the market[1].

Performance of Third Parties

The success of Nuvessa is also dependent on the performance of third-party collaborators involved in its development, manufacturing, and commercialization. Any failure or delay by these parties can impact the product's financial trajectory[1].

Intellectual Property and Patent Protection

Intellectual property rights are critical for protecting Nuvessa from competition. However, the lack of patent protection for the active ingredients in Nuvessa exposes it to competition from other formulations using the same active ingredients[1].

Safety and Efficacy

The safety and efficacy of Nuvessa have been established through clinical trials, but ongoing monitoring and post-marketing studies are essential to maintain regulatory approval and market confidence. Any unexpected safety concerns or adverse event reports can negatively impact sales and revenue[5].

Market Fluctuations and Investor Expectations

The stock market performance of Daré Bioscience, influenced by factors such as quarterly operating results and investor expectations, can also affect the financial trajectory of Nuvessa. Fluctuations in stock prices and potential securities litigation are risks that the company faces[1].

Conclusion

Nuvessa's market dynamics and financial trajectory are influenced by a complex array of factors, including regulatory approvals, market competition, intellectual property protection, and the performance of third-party collaborators. While it addresses a significant unmet need in women's health, navigating these challenges is crucial for its long-term success.

Key Takeaways

• Approval and Indications: Nuvessa is approved for treating bacterial vaginosis in nonpregnant women and adolescents.
• Market Positioning: It fills a gap in the women's health market with a unique formulation.
• Financial Trajectory: Revenue is generated through sales, royalties, and milestone payments, but faces challenges like regulatory hurdles, market acceptance, and competition.
• Third-Party Performance: Success is dependent on the performance of collaborators.
• Intellectual Property: Lack of patent protection for active ingredients is a risk.
• Safety and Efficacy: Ongoing monitoring is essential to maintain regulatory approval and market confidence.

FAQs

What is Nuvessa used for?

Nuvessa is used for the treatment of bacterial vaginosis (BV) in nonpregnant women and adolescent females.

When was Nuvessa approved by the FDA?

Nuvessa was approved by the FDA on March 24, 2014.

What is the unique aspect of Nuvessa's formulation?

Nuvessa is formulated as a vaginal gel, providing targeted treatment with minimal systemic absorption.

What are some of the challenges Nuvessa faces in the market?

Nuvessa faces challenges such as regulatory hurdles, market acceptance, competition from generic products, and the lack of patent protection for its active ingredients.

How does Daré Bioscience generate revenue from Nuvessa?

Daré Bioscience generates revenue from Nuvessa through sales, royalty payments, and milestone payments from licensing agreements.

Sources

1. Daré Bioscience, Inc. - 10K - Annual Report - March 30, 2023 - Fintel
2. Prescribing Information - Nuvessa - Nuvessa
3. STATISTICAL REVIEW AND EVALUATION - FDA - FDA
4. DARÉ BIOSCIENCE, INC. - IR Daré Bioscience
5. NUVESSA PAC REVIEW 2023 - FDA - FDA