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
Patent Applications:	556
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
Denmark	1446122
Australia	2002333894
European Patent Office	1674102
Poland	367358
South Africa	200401366	USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISODERS
Ecuador	SP045069	USO DE FLIBANSERINA EN EL TRATAMIENTO DE TRASTORNOS SEXUALES

FLIBANSERIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flibanserin

Introduction

Flibanserin, marketed under the brand name Addyi, is the first FDA-approved medication for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. The drug's journey to market approval and its subsequent performance provide valuable insights into the complex interplay of medical, regulatory, and market forces.

Development and Approval Process

Flibanserin was initially developed as an antidepressant but failed in clinical trials for this indication. However, observations of increased sexual desire in some female participants led to its repurposing for treating HSDD[2][5].

The approval process was marked by significant challenges. In 2010, the FDA rejected the New Drug Application (NDA) due to concerns over the drug's efficacy and safety profile. Boehringer Ingelheim, the initial developer, discontinued its development of flibanserin following this rejection. Sprout Pharmaceuticals later acquired the rights to the drug and resubmitted the NDA, addressing the FDA's concerns through additional studies. In June 2015, the FDA Advisory Committee recommended approval, and the FDA subsequently approved flibanserin for the treatment of HSDD in premenopausal women[1][5].

Market Reception

The initial market response to flibanserin was slow. During the first three weeks after its introduction in 2015, only 227 prescriptions were written. Several factors contributed to this slow start, including the need for physicians to undergo online training, the daily dosing regimen, the high cost of approximately $400 per month, and ongoing questions about the drug's efficacy and necessity[1].

As of February 2016, the number of prescriptions remained low, with fewer than 4,000 prescriptions written. This slow uptake was partly due to the stringent requirements for prescribing the drug, including the need for healthcare providers to be certified and the necessity for patients to sign a risk acknowledgment form due to potential side effects such as fainting and extreme sleepiness[1][2].

Financial Trajectory

The financial performance of flibanserin has been influenced by several key factors:

Acquisition and Ownership

In August 2015, shortly after the FDA approval, Valeant Pharmaceuticals acquired Sprout Pharmaceuticals for approximately $1 billion in cash, plus a share of future profits based on certain milestones. This acquisition highlighted the significant financial interest in the drug despite its slow market start[1].

Market Size and Growth

The global female sexual dysfunction treatment market, within which flibanserin operates, is projected to grow significantly. From a market size of $451.7 million in 2023, it is expected to reach $993.9 million by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 11.9% during the forecast period. North America, particularly the U.S., dominates this market, driven by increased investment in research and development and the rising adoption of therapies among women[4].

Sales Performance

Despite the slow initial response, the market for female sexual dysfunction treatments is expanding. However, flibanserin's specific sales figures have not been as robust as anticipated. The drug's high cost, the need for daily dosing, and concerns over side effects have all contributed to its relatively low prescription rates compared to other treatments in the market[1][4].

Regulatory and Safety Considerations

The FDA's approval of flibanserin came with specific conditions, including the requirement for healthcare providers to be certified and for patients to be informed about the drug's side effects. The FDA also mandated studies to determine if flibanserin impairs driving ability and interferes with other biochemical pathways, reflecting ongoing concerns about the drug's safety profile[1].

Market Challenges

Several challenges have impacted the market dynamics of flibanserin:

Awareness and Stigma

Low awareness of sexual dysfunction disorders among women, coupled with the stigma associated with these conditions, has hindered the market growth. Unlike male sexual dysfunction, which has more visible and widely recognized treatments, female sexual dysfunction remains frequently overlooked[4].

Competition and Market Share

The market for female sexual dysfunction treatments is consolidated, with a few key players dominating the landscape. Pfizer Inc., for example, holds a significant market share due to its strong product portfolio, including Premarin. Flibanserin, despite its unique indication, faces competition from other treatments and must navigate the complex landscape of patient and healthcare provider preferences[4].

Side Effects and Risk Profile

Flibanserin's side effects, such as fainting and extreme sleepiness, have been a significant concern. These side effects, along with the drug's history as a failed antidepressant, have raised questions about its risk-benefit profile and contributed to cautious prescribing practices[2][5].

Key Takeaways

• Approval and Market Introduction: Flibanserin was approved by the FDA in 2015 after a lengthy and challenging development process.
• Market Reception: The initial market response was slow due to various factors including certification requirements, high cost, and concerns over efficacy and safety.
• Financial Trajectory: The drug's financial performance is tied to the growing market for female sexual dysfunction treatments, but its sales have been impacted by several challenges.
• Regulatory and Safety Considerations: The FDA's approval came with specific conditions to address safety concerns.
• Market Challenges: Low awareness, stigma, competition, and side effects have all influenced the drug's market dynamics.

FAQs

What is flibanserin used for?

Flibanserin is used for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, characterized by limited or absent sexual fantasies or desires that cause personal distress or relationship difficulties[1][5].

Why was flibanserin initially rejected by the FDA?

Flibanserin was initially rejected due to concerns over its efficacy and safety profile, including the failure to demonstrate a statistically significant effect on the co-primary endpoint of sexual desire and overly restrictive entry criteria for clinical trials[1].

How has the market responded to flibanserin?

The market response to flibanserin has been slow, with fewer than 4,000 prescriptions written as of February 2016, due to factors such as certification requirements, high cost, and concerns over efficacy and safety[1].

What are the potential side effects of flibanserin?

Flibanserin can cause side effects such as fainting and extreme sleepiness, which have been significant concerns and have impacted its prescribing rates[1][2].

Who acquired Sprout Pharmaceuticals after the FDA approval of flibanserin?

Valeant Pharmaceuticals acquired Sprout Pharmaceuticals in August 2015 for approximately $1 billion in cash, plus a share of future profits based on certain milestones[1].

References

1. Wikipedia: Flibanserin
2. Mad in America: Flibanserin: The Female Viagra is a Failed Me-too Antidepressant
3. Market Research Pulse: Flibanserin API Market Trends, Scope And Outlook
4. Fortune Business Insights: Female Sexual Dysfunction Treatment Market Size, Share [2030]
5. NCBI Bookshelf: Flibanserin - StatPearls