PHEXXI Drug Patent Profile

Which patents cover Phexxi, and when can generic versions of Phexxi launch?

Phexxi is a drug marketed by Evofem Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in eighteen countries.

The generic ingredient in PHEXXI is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Phexxi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 15, 2033. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PHEXXI

International Patents:	46
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Drug Prices:	Drug price information for PHEXXI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHEXXI
What excipients (inactive ingredients) are in PHEXXI?	PHEXXI excipients list
DailyMed Link:	PHEXXI at DailyMed

See drug prices for PHEXXI

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

Constraining patent/regulatory exclusivity:

11,337,989

NDA:

208352

Dosage:

GEL;VAGINAL

^*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 PHEXXI

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

Sponsor	Phase
University of Hawaii Foundation	Early Phase 1
Queen's Medical Center	Early Phase 1
Parexel	Phase 3

See all PHEXXI clinical trials

Pharmacology for PHEXXI

Drug Class	Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Paragraph IV (Patent) Challenges for PHEXXI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHEXXI	Vaginal Gel	citric acid; lactic acid; potassium bitartrate	1.8%/1%/0.4%	208352	1	2023-02-28

US Patents and Regulatory Information for PHEXXI

PHEXXI is protected by four US patents.

This potential generic entry date is based on patent 11,337,989.

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
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,337,989
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,439,610		Y	Y
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,992,472
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	10,568,855

Expired US Patents for PHEXXI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020	6,706,276

International Patents for PHEXXI

When does loss-of-exclusivity occur for PHEXXI?

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

Australia

Brazil

China

Denmark

European Patent Office

Israel

Japan

Mexico

New Zealand

Russian Federation

South Africa

South Korea

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 PHEXXI around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2021001742
Germany	60143566
Mexico	365905	COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.)
Japan	2020125298
World Intellectual Property Organization (WIPO)	2015095793
Hungary	230315	Összetételek és alkalmazásuk patogén mikrobák és spermatozoák csapdázására (Compositions and methods for trapping pathogenic microbes and spermatozoa)
South Africa	201500111	COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES

Market Dynamics and Financial Trajectory for PHEXXI: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

PHEXXI ( orale contraceptive vaginal gel) represents an innovative approach within female reproductive health, gaining attention for its non-hormonal, hormone-free formulation designed exclusively for contraception. As a Prescription Drug Product marketed by Sebela Pharmaceuticals, PHEXXI’s market trajectory is influenced by evolving reproductive health needs, regulatory frameworks, competitive landscape, and payer dynamics. This analysis delineates the fuerzas shaping PHEXXI’s market dynamics and projects its financial trajectory over the coming years.

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Market Overview and Positioning

Product Profile and Unique Selling Proposition

PHEXXI distinguishes itself in the contraceptive market through its hormone-free, vaginal gel delivery system. Launched in 2020, it targets women seeking non-hormonal options, addressing concerns associated with hormonal contraceptives such as mood alterations, weight gain, and cardiovascular risks [1].

Target Demographics and Adoption Rates

The core demographic spans women aged 18-45, increasingly prioritizing contraceptive choices with fewer systemic effects. According to the CDC, approximately 62% of women aged 15–44 in the U.S. use some form of contraception, with a shifting preference toward non-hormonal methods [2]. Adoption of PHEXXI remains nascent but poised for growth driven by the rising demand for hormone-free options.

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Market Dynamics Influencing PHEXXI

1. Competitive Landscape

The U.S. contraceptive market comprises combined oral contraceptives, intrauterine devices (IUDs), patches, vaginal rings, and barrier methods. PHEXXI faces competition primarily from hormonal contraceptives with well-established brand recognition but lacks comparable non-hormonal alternatives.

• Hormonal dominance: Oral contraceptives command approximately 70% of the market share in the U.S. [3].
• Emerging Non-hormonal Options: Competitive products like the non-hormonal IUDs (e.g., copper IUDs) and the recent approval of alternative methods impact market share dynamics.

The non-hormonal niche remains under-penetrated, presenting growth opportunities but also hurdles related to consumer awareness and clinician adoption.

2. Regulatory and Reimbursement Environment

Regulatory approval from FDA in 2020 was a significant milestone, affirming PHEXXI’s safety and efficacy. However, reimbursement challenges persist, as payers often favor established hormonal methods due to familiarity and cost considerations.

• Coverage and reimbursement policies: Initial coverage by major insurers has been gradual, affecting patient access.
• Pricing strategy: PHEXXI’s pricing (~$150–$200 per prescription) is competitive but faces scrutiny given the predominantly outpatient and outpatient–sidepopulated market.

3. Consumer Perception and Acceptance

Limited awareness constrains initial uptake. However, growing health consciousness, coupled with increased dialogue on hormone-related side effects, enhances consumer receptivity.

• Physician advocacy: Emphasizes the need for provider education to facilitate recommendation.
• Patient preferences: Favor non-hormonal, preservative-free, and user-controlled methods, aligning with PHEXXI’s positioning.

4. Distribution Channels and Marketing

Distribution relies on gynecologists, family practitioners, and pharmacies. Digital marketing and direct-to-consumer campaigns are emerging to increase visibility, particularly targeted via social media to reach millennial women.

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Financial Trajectory and Projections

1. Revenue Drivers

• Volume growth: As adoption rates increase, revenue hinges on prescription volumes.
• Pricing strategy: Maintaining competitive pricing while ensuring margins is vital.
• Market expansion: Penetrating international markets and expanding indications (e.g., emergency contraception) could diversify revenue streams.

2. Revenue and Market Share Projections

Considering PHEXXI’s current modest market penetration, projections suggest the following:

• Short-term (1–2 years): Steady growth with an estimated 15–20% annual rise in prescriptions, driven by increased clinician awareness and consumer acceptance.

• Mid-term (3–5 years): Accelerated growth potential, reaching a 2–3% share of the broader contraceptive market, translating into revenues of approximately $50–$100 million annually, contingent on market expansion and reimbursement landscapes [4].

• Long-term: As non-hormonal options gain traction, PHEXXI’s market share could approach 5% within niche segments, potentially exceeding $150 million in annual revenues.

3. Cost Considerations

Manufacturing economies of scale may improve gross margins. Marketing, clinical education campaigns, and clinician outreach represent significant R&D and promotional costs, impacting net profitability in early years.

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Risks and Opportunities

Risks

• Market penetration barriers: Limited consumer and clinician awareness.
• Reimbursement constraints: Insufficient coverage could limit access.
• Competitive threats: Future emergence of similar non-hormonal therapies.

Opportunities

• Expanding indications: Investigating additional uses such as emergency contraception.
• International expansion: Entry into global markets with demographic and regulatory similarities.
• Partnerships: Collaborations with healthcare providers and payers can accelerate adoption.

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Conclusion

PHEXXI’s future hinges on strategic execution within a dynamic reproductive health market. Its non-hormonal profile aligns with shifting consumer preferences, and ongoing efforts to increase awareness, payer coverage, and clinician endorsement will be critical. Financially, the product exhibits promising growth potential, especially as awareness and adoption increase. Careful navigation of reimbursement landscapes and competitive pressures will determine its ultimate market success.

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Key Takeaways

• PHEXXI occupies a niche market with significant growth potential due to rising demand for hormone-free contraceptive options.
• Market penetration will depend heavily on clinician and consumer awareness campaigns, reimbursement policies, and competitive positioning.
• Short- to mid-term projections suggest steady revenue growth, with the potential for substantial expansion over the next five years.
• International expansion and added indications offer avenues for diversification and revenue enhancement.
• Strategic partnerships and health policy advocacy will be crucial in overcoming access barriers and maximizing financial performance.

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FAQs

Q1. What is the primary differentiator of PHEXXI in the contraceptive market?
A1. PHEXXI’s main differentiator is its hormone-free, preservative-free, vaginal gel formulation offering a non-hormonal, user-controlled contraception method.

Q2. How does PHEXXI compare cost-wise to hormonal contraceptives?
A2. PHEXXI’s retail price is roughly $150–$200 per prescription, which is comparable to hormonal options like oral contraceptives but may be slightly higher primarily due to manufacturing and distribution costs associated with its unique formulation.

Q3. What challenges does PHEXXI face in capturing market share?
A3. Key challenges include limited consumer awareness, reimbursement hurdles, clinician familiarity, and competition from established hormonal methods and other non-hormonal options.

Q4. What are the growth prospects for PHEXXI in international markets?
A4. International expansion prospects are favorable, particularly in regions with increasing acceptance of female-controlled contraceptives and supportive regulatory environments, though market entry requires localization and regulatory compliance.

Q5. How might PHEXXI’s market share evolve over the next five years?
A5. With effective awareness campaigns and reimbursement strategies, PHEXXI could capture up to 5% of its target niche within five years, translating into significant revenue growth.

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References

[1] Sebela Pharmaceuticals. PHEXXI Product Overview. 2022.
[2] CDC. Contraceptive Use in the United States. 2022.
[3] IBISWorld. Contraceptive Manufacturing in the US. 2022.
[4] MarketWatch. Female Contraceptive Market Analysis. 2023.