FLIBANSERIN - Generic Drug Details

What are the generic sources for flibanserin and what is the scope of patent protection?

Flibanserin is the generic ingredient in one branded drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for FLIBANSERIN

International Patents:	42
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	19
What excipients (inactive ingredients) are in FLIBANSERIN?	FLIBANSERIN excipients list
DailyMed Link:	FLIBANSERIN at DailyMed

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

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.

Recent Clinical Trials for FLIBANSERIN

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

Sponsor	Phase
Andrew McDonald	Phase 2
Mohit Khera	Phase 2
Sprout Pharmaceuticals, Inc	Phase 2

See all FLIBANSERIN clinical trials

Pharmacology for FLIBANSERIN

Mechanism of Action

P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLIBANSERIN

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FLIBANSERIN

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 FLIBANSERIN

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 FLIBANSERIN

Country	Patent Number	Title	Estimated Expiration
China	1571670
Portugal	1446122
China	101347431
Argentina	037109	USO DE FLIBANSERINA
Hungary	0401023
Yugoslavia	30004
Poland	367358

Market Dynamics and Financial Trajectory for Flibanserin: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

Flibanserin, marketed under the brand name Addyi, is a pharmacological agent initially developed by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Its journey from development to market reflects nuanced market dynamics influenced by regulatory, clinical, societal, and competitive factors. Analyzing Flibanserin’s market trajectory offers insights into the evolving landscape of female sexual health therapeutics and presents strategic considerations for industry stakeholders.

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Historical Development and Regulatory Milestones

Initial Discovery and Development

Flibanserin was originally synthesized as an antidepressant but was repurposed due to its serotonergic activity.[1] The key pharmacodynamics involve serotonergic receptor modulation—primarily as a serotonin 1A receptor agonist and 2A receptor antagonist—aiming to balance neurotransmitter activity implicated in sexual desire.

FDA Approval and Market Challenges

In 2015, the U.S. Food and Drug Administration (FDA) approved Flibanserin for HSDD, marking a rare instance of a drug targeting female sexual dysfunction.[2] However, approval was controversial, citing concerns about limited efficacy and potential adverse effects such as hypotension and syncope.[3] Regulatory hurdles slowed uptake and stimulated debates on the drug's risk-benefit profile.

Post-Approval Market Dynamics

Following approval, Sprout Pharmaceuticals was acquired by Valeant Pharmaceuticals (later Bausch Health), with the drug facing challenges in gaining broad prescriber acceptance. Promotional strategies and patient awareness campaigns have aimed to counter healthcare providers’ skepticism regarding clinical efficacy, which remains a barrier to substantial market penetration.

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Market Size and Growth Drivers

Target Demographics and Market Potential

The primary market includes premenopausal women diagnosed with HSDD. Prevalence estimates suggest approximately 10-15% of women experience hypoactive sexual desire, translating into a significant, albeit niche, market segment.[4] However, actual prescriptions have remained modest, constrained by societal stigmas, limited clinician familiarity, and the drug’s dubious efficacy.

Growth Drivers

• Increased Awareness and Feminine Sexual Health Focus: Growing societal acceptance and focus on female sexual health are encouraging prescription growth.

• Expanding Indications: Research exploring Flibanserin's utility in other sexual dysfunctions or mood disorders could expand its market scope.

• Reimbursement and Pricing Strategies: Successful navigation of insurance reimbursement policies can unlock greater patient access, bolstering sales.

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Competitive Landscape

Existing and Emerging Therapies

Flibanserin's primary competitors include off-label treatments, non-pharmacological interventions, and potential future drugs targeting similar pathways. Agents such as Bremelanotide (Vyleesi) have gained FDA approval for HSDD and may pose competitive pressures.[5]

Pipeline Developments

Research into other serotonergic and neurotransmitter-based agents continues, with some candidates aiming for improved efficacy profiles or fewer side effects, threatening Flibanserin’s market share in the long term.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its 2015 approval, Flibanserin’s sales have been modest, with estimates reporting annual sales fluctuating around $50–$100 million globally.[6] Contributing factors include limited prescriber acceptance and stringent safety warnings.

Forecasting Future Revenue

Projections indicate incremental growth driven by increased awareness and potential label expansions. Market analysts suggest that with strategic marketing and reimbursement negotiations, annual global sales could approach $200 million over the next five years.[7] However, the market remains constrained by the drug's controversial profile.

Pricing Strategies and Market Penetration

Pricing remains a critical determinant of market penetration. The drug is priced at approximately $400–$500 per month per patient, which can deter usage in cost-sensitive healthcare systems. Negotiating insurance coverage is essential to expand access.

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Market Challenges and Opportunities

Challenges

• Efficacy Concerns: Critics cite limited clinical benefits demonstrated in trials, which hampers prescriber confidence.
• Safety Profile: Warnings on hypotension and syncope restrict broader use.
• Societal Stigma: Psychological barriers hinder patient demand.

Opportunities

• Expanding Awareness: Educational campaigns can improve patient-doctor dialogue.
• Revising Labeling and Indications: New data supporting broader use or safer profiles can enhance sales.
• Combination Therapies: Developing adjunct therapies may improve efficacy perceptions.

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Regulatory and Policy Impact

Regulatory agencies influence market trajectory through approval standards and safety mandates. Ongoing post-marketing surveillance could lead to label updates either expanding or restricting use. Policy shifts emphasizing women's health could foster a more favorable environment for Flibanserin and similar drugs.

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Conclusion

The financial trajectory of Flibanserin is characterized by cautious growth, dictated by societal acceptance, regulatory scrutiny, and competitive advances. While the global market remains niche, strategic repositioning, improved clinician and patient education, and potential indication expansion could enhance its market viability. The drug exemplifies the broader complexities surrounding female sexual health therapeutics, where medical, societal, and economic factors intertwine.

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Key Takeaways

• Flibanserin holds a unique and evolving position within the female sexual health market, facing both opportunities and substantial challenges.
• Market growth hinges on increased awareness, insurance reimbursement, and validation of clinical benefits.
• Competition from newer agents like Bremelanotide necessitates strategic differentiation and potential combination therapies.
• Regulatory insights and post-marketing safety data significantly influence sales trajectories.
• Stakeholders must navigate societal stigma, efficacy debates, and safety concerns to optimize market performance.

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FAQs

1. What is the current global market size for Flibanserin?
The global market size is modest, with annual sales estimated around $50–$100 million. Growth potential exists but is limited by societal and regulatory factors.

2. How does Flibanserin compare to its main competitor, Bremelanotide?
While Flibanserin acts as a serotonin receptor modulator for HSDD in premenopausal women, Bremelanotide is a melanocortin receptor agonist approved for similar indications, with differing administration routes and side effect profiles, intensifying market competition.

3. What are key barriers to Flibanserin’s wider adoption?
Barriers include modest clinical efficacy, safety warnings about hypotension and syncope, social stigma, and high pricing without extensive insurance coverage.

4. Can Flibanserin be used for other indications?
Currently, approved solely for HSDD, but ongoing research into related sexual or mood disorders may expand its indications contingent on clinical validation.

5. How might regulatory policies impact Flibanserin’s future sales?
Regulatory updates, such as label expansions or safety warnings, can significantly influence prescribing practices and insurance reimbursement, either positively or negatively affecting sales.

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References

[1] Stahl SM. The serotonin hypothesis of depression: clinical and experimental evidence. J Clin Psychiatry. 1988;49(Suppl):3–8.
[2] FDA News Release. FDA approves first drug for low sexual desire disorder in premenopausal women. 2015.
[3] U.S. Food and Drug Administration. Addyi (flibanserin) prescribing information. 2015.
[4] Kingsberg SA, et al. Female sexual dysfunction: What are the implications for practice? J Womens Health (Larchmt). 2018;27(2):222–227.
[5] Buvat J, et al. The pharmacology of Bremelanotide and its use in female sexual dysfunction. Expert Opin Pharmacother. 2019;20(7):842–849.
[6] EvaluatePharma. Flibanserin sales data. 2022.
[7] Market Research Future. Female Sexual Dysfunction Drugs Market Report. 2022.