ADDYI Drug Patent Profile

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

Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in twenty-nine countries.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.

DrugPatentWatch^® Generic Entry Outlook for Addyi

Addyi was eligible for patent challenges on August 18, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 9, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ADDYI

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	861
Drug Prices:	Drug price information for ADDYI
What excipients (inactive ingredients) are in ADDYI?	ADDYI excipients list
DailyMed Link:	ADDYI at DailyMed

See drug prices for ADDYI

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

NDA:

022526

Dosage:

TABLET;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 ADDYI

Mechanism of Action

P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ADDYI

ADDYI is protected by one 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
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes

Expired US Patents for ADDYI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015

International Patents for ADDYI

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

Country	Patent Number	Title	Estimated Expiration
Poland	208744
Montenegro	P42808
Ecuador	SP045069	USO DE FLIBANSERINA EN EL TRATAMIENTO DE TRASTORNOS SEXUALES
Colombia	5560572	COMPUESTO POLIMORFO ESTABLE DE FLIBANSERINA, PROCEDIMIENTO INDUSTRIAL PARA SU PREPARACION, Y USO DEL MISMO PARA PREPARAR MEDICAMENTOS
Hong Kong	1070063

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ADDYI

Last updated: July 27, 2025

Introduction

ADDYI (nesam etide), marketed by Sebela Pharmaceuticals, represents a significant advancement in the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, ADDYI's market introduction underscores a strategic intersection of unmet medical needs and emerging therapeutics within women's health. This analysis examines the current market landscape, key drivers shaping its trajectory, revenue forecasts, competitive positioning, and implications for stakeholders.

Overview of ADDYI and Its Therapeutic Context

ADDYI is a centrally acting selective serotonin receptor modulator (SSRM) approved specifically for premenopausal women experiencing acquired, generalized HSDD. Unlike traditional hormonal treatments, ADDYI targets neurotransmitters, primarily serotonin, to modulate sexual desire. Its FDA approval was founded on clinical trials demonstrating statistically significant improvements in sexual desire scores, although efficacy outcomes have elicited ongoing debate within the medical community (FDA, 2019)[1].

HSDD is a prevalent condition affecting approximately 10-15% of women globally, with significant psychosocial and quality-of-life implications. Historically, treatment options have been limited, creating unmet demand. The approval of ADDYI introduced a novel therapeutic class, catalyzing a new segment within the women's health pharmaceutical market.

Market Dynamics: Drivers and Challenges

Unmet Medical Need and Market Demand

The prevalence of HSDD underscores a substantial unmet clinical need, positioning ADDYI within a promising therapeutic niche. Market research indicates that millions of premenopausal women suffer from HSDD, yet treatment remains underutilized due to limited options and social barriers. The endorsement of ADDYI by clinicians hinges on its efficacy, safety profile, and regulatory acceptance, influencing market penetration.

Regulatory and Reimbursement Landscape

The FDA's approval marked a pivotal milestone for ADDYI, but subsequent reimbursement decisions have been varied. Medicare and commercial payers' coverage policies impact patient access and, consequently, sales volume. The medication's patent status, compounded by Sebela's strategic patent filings expiring around 2030, shapes long-term exclusivity and profitability prospects.

Competitive Environment

While ADDYI claims a first-mover advantage in the HSDD pharmacotherapy space, it faces emerging competition from other drug development efforts, including interventions targeting hormonal pathways or psychosexual therapy enhancements. Companies like Sprout Pharmaceuticals, with its ongoing pipeline, may introduce competitive offerings. Additionally, the social stigma surrounding sexual dysfunction treatments influences market uptake.

Cultural and Societal Factors

Evolving societal attitudes toward women's sexual health foster a more receptive environment for pharmaceutical solutions. However, persistent stigmas and misconceptions may delay acceptance, requiring strategic educational campaigns by manufacturers.

Pharmacovigilance and Safety Concerns

Post-marketing surveillance remains crucial. Reports of adverse events or safety warnings could impact prescribing patterns, alter the drug's marketability, and influence financial performance.

Financial Trajectory and Revenue Forecasting

Initial Market Adoption

Following FDA approval, ADDYI's initial sales trajectory was modest, constrained by limited awareness, cautious prescribing practices, and insurance coverage hurdles. In the first full fiscal year (2020), estimates suggest revenues ranged between $20-30 million, with growth potential tied to increased physician familiarity and expanded payer coverage (Sebela Pharmaceuticals, 2021)[2].

Growth Projections

Analysts project a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, driven by:

• Increasing diagnosis rates as awareness campaigns expand.
• Broader insurance coverage policies.
• New formulations or indications benefiting from patent protections.
• Expansion into international markets, contingent on regulatory approvals.

Market Penetration Strategies

Sebela has employed targeted marketing, physician education, and partnerships with healthcare providers to expand reach. The development of adjunct therapies or combination products could further enhance revenue streams.

Risks and Limitations

Factors tempering growth include:

• Off-label use limitations.
• Regulatory scrutiny regarding efficacy claims.
• Competitive entrants with alternative therapeutic approaches.
• Cultural resistance in diverse markets.

Long-Term Revenue Outlook

By 2027, estimates envisage revenue reaching $150-200 million annually in the U.S. alone, assuming successful market penetration and favorable reimbursement policies. International expansion remains a key, yet uncertain, growth avenue.

Competitive Positioning and Market Share

ADDYI's nuanced profile as the first pharmacotherapy for HSDD affords a significant competitive edge. However, maintaining dominance necessitates continuous clinical validation, robust pharmacovigilance, and strategic marketing. Competitors are exploring hormonal modulators, non-pharmacological therapies, and digital health interventions, which could reshape the market landscape.

Regulatory and Economic Considerations

Patent expiry around 2030 and potential biosimilar entrants present revenue uncertainties. Cost-effectiveness analyses and pricing strategies are critical for maximizing market penetration while ensuring sustainable margins.

Conclusion

The trajectory of ADDYI exemplifies a niche yet growing segment in women's sexual health. Its financial outlook hinges on early adoption rates, payer acceptance, and competitive dynamics. While launch-phase hurdles persist, ongoing efforts to educate providers and patients, coupled with favorable societal shifts, position ADDYI for steady growth over the next decade.

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Key Takeaways

• Market Opportunity: Significant unmet need in treating HSDD offers lucrative potential, supported by prevalence data and regulatory approval.
• Growth Drivers: Increasing awareness, insurance coverage, and international expansion are central to revenue growth.
• Challenges: Market penetration barriers include social stigma, regulatory uncertainties, and emerging competitors.
• Financial Outlook: Projected revenues suggest robust growth, with CAGR of approximately 15-20% over five years, reaching ~$200 million annually by 2027.
• Strategic Imperatives: Continued clinical research, proactive marketing, and adaptive pricing strategies will be critical in securing long-term profitability.

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FAQs

1. What are the primary factors influencing ADDYI's market penetration?
Market penetration is driven by physician and patient awareness, insurance reimbursement policies, societal acceptance, and competition from alternative therapies.

2. How does ADDYI differentiate itself from other treatments for sexual dysfunction?
ADDYI's unique mechanism as a serotonin modulator, its FDA approval for HSDD in premenopausal women, and its positioning as a first-in-class pharmacotherapy differentiate it within the market.

3. What regulatory challenges could affect ADDYI’s future sales?
Potential challenges include safety concerns raised during post-marketing surveillance, evolving FDA guidance on sexual health medications, and international regulatory approvals.

4. How important is international expansion for ADDYI’s financial success?
International markets can significantly augment revenue streams; however, regulatory approval processes, cultural acceptance, and local healthcare policies influence timing and success.

5. What strategies should Sebela Pharmaceuticals prioritize to maximize ADDYI's market share?
Priorities include expanding payer coverage, enhancing physician education, conducting post-market studies to reinforce efficacy, and exploring combination therapies or new indications.

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References

[1] Food and Drug Administration. (2019). FDA approves first treatment for hypoactive sexual desire disorder in premenopausal women.
[2] Sebela Pharmaceuticals. (2021). Annual Financial Report.