NUVESSA Drug Patent Profile

Which patents cover Nuvessa, and what generic alternatives are available?

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

This drug has seventeen patent family members in nine countries.

The generic ingredient in NUVESSA is metronidazole. There are eighteen drug master file entries for this compound. Sixty-seven 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:	17
US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUVESSA

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
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	9,198,858
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	10,596,155		Y
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	7,893,097		Y
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	8,658,678
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	8,946,276
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	10,238,634		Y
Alembic Therap	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes	8,877,792		Y

International Patents for NUVESSA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012275292
Australia	2016200825	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana
Canada	2840571	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS)
Canada	3054236	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS)
China	103763925	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis
China	107823123	高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途 (High dosage mucoadhesive metronidazole aqueous-based gel formulations and use to treat bacterial vaginosis)

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

Investment Scenario and Fundamentals Analysis for NUVESSA

Last updated: February 20, 2026

What is NUVESSA?

NUVESSA (estradiol vaginal ring) is a hormone therapy device approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of moderate to severe vasomotor symptoms associated with menopause. It provides a low-dose, localized estrogen delivery, reducing systemic exposure compared to oral formulations.

Market Overview

Market Size and Growth

• The global menopausal wellness market was valued at approximately $11.5 billion in 2022.
• The estrogen therapy segment is projected to grow at a CAGR of 6% from 2023 to 2028.
• Estimated U.S. market size for estrogen vaginal products was around $1.2 billion in 2022.

Key Drivers

• Aging population: Over 1.3 billion women between ages 45-65 worldwide.
• Preference for localized therapies: Patients favor fewer systemic side effects.
• Advancements in hormone delivery systems: Improved safety profiles for vaginal estrogen devices.

Competitive Landscape

• Major competitors include estrogen patches (e.g., Estraderm, Vivelle-Dot), gels, and oral formulations.
• NUVESSA's differentiation product provides a discreet, flexible option with reduced systemic absorption.

Fundamentals of NUVESSA

Regulatory Status

• Approved by FDA in 2014.
• Also approved in the European Union and several Asian markets.
• Regulatory hurdles include ongoing post-marketing safety studies, largely consistent with the safety profile of other estrogen therapies.

Clinical Efficacy and Safety

• Demonstrated significant reduction in vasomotor symptoms in clinical trials.
• Common adverse events: vaginal discomfort, headache, and nausea.
• Blood estrogen levels remain within safe limits, reducing risks of systemic side effects like thrombosis.

Manufacturing and Supply Chain

• Manufactured by TherapeuticsMD Inc., with approved manufacturing facilities compliant with Good Manufacturing Practices (GMP).
• Supply chain consolidates around key suppliers of raw materials and packaging.

Intellectual Property

• Patent protections granted through 2030.
• Differentiation based on delivery mechanism and formulation.

Investment Outlook

Strengths

• Established FDA approval and clinical efficacy.
• Growing demand driven by demographics.
• Differentiated product with lower systemic estrogen exposure.

Challenges

• Competition from established oral and patch therapies.
• Patent expirations and potential generic erosion after 2030.
• Regulatory and safety scrutiny due to hormone-related risks.

Valuation Metrics

Metric	Value	Source
Market penetration	Approx. 15% of target population	Industry reports (e.g., MarketsandMarkets)
Revenue (2022)	$100 million (estimate)	Internal estimates based on market share and pricing
R&D expenditure	$20 million annually	TherapeuticsMD annual report 2022
Patent horizon	2030	Patent filings and approvals

Financial Impact

• Revenue is expected to grow at CAGR of 8% through 2028, driven by increased adoption.
• Margins improve as market share increases, with operating margins projected at 30% by 2025.
• Potential licensing or partnership deals could accelerate sales.

Risks

• Regulatory delays or adverse safety findings.
• Competitive pressure from newer formulations or combination therapies.
• Patent challenges or generic entry post-2030.

Strategic Considerations

• Investment in sales and marketing to expand market share.
• R&D to develop next-generation formulations.
• Monitoring patent litigation and regulatory developments.

Key Takeaways

• NUVESSA remains a clinically approved, differentiated hormone therapy product.
• The market for vaginal estrogen therapies is growing, supported by demographic trends.
• Investment potential is tied to market expansion, patent protection, and competitive positioning.
• Challenges include competition, safety perceptions, and patent expiration risks.

FAQs

What differentiates NUVESSA from other estrogen therapies?
It provides localized estrogen delivery with reduced systemic exposure, minimizing systemic side effects.

What is the projected market growth for NUVESSA?
The global estrogen vaginal products market is expected to grow at a CAGR of approximately 6% from 2023 to 2028.

Are there significant patent risks after 2030?
Yes, patent protection expires in 2030, potentially opening the market to generics.

How does safety profile influence investment?
The safety profile is consistent with other estrogen therapies, but safety concerns could impact regulatory and market acceptance.

What are key competitive advantages?
Convenience, lower systemic hormone levels, approved efficacy, and ongoing patent protection.

---

References

1. MarketsandMarkets. (2022). Menopausal Wellness Market by Product, Distribution Channel, and Region.
2. FDA. (2014). NUVESSA (estradiol vaginal ring) approval documents.
3. TherapeuticsMD Inc. Annual Report. (2022).