BRISDELLE Drug Patent Profile

When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?

Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in thirty-six countries.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brisdelle

A generic version of BRISDELLE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20^th, 2017.

Summary for BRISDELLE

International Patents:	84
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	5
Patent Applications:	184
Drug Prices:	Drug price information for BRISDELLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRISDELLE
What excipients (inactive ingredients) are in BRISDELLE?	BRISDELLE excipients list
DailyMed Link:	BRISDELLE at DailyMed

See drug prices for BRISDELLE

See drug sales revenues for BRISDELLE

Recent Clinical Trials for BRISDELLE

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

Sponsor	Phase
Yung Shin Pharm. Ind. Co., Ltd.	Phase 2
Noven Therapeutics	Phase 1
Noven Therapeutics	Phase 3

See all BRISDELLE clinical trials

Paragraph IV (Patent) Challenges for BRISDELLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRISDELLE	Capsules	paroxetine mesylate	7.5 mg	204516	1	2014-04-07

US Patents and Regulatory Information for BRISDELLE

BRISDELLE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes			Y	Y
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes				Y
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes			Y	Y

Expired US Patents for BRISDELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013

International Patents for BRISDELLE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20090040453
Estonia	200200633
Portugal	2719385
Canada	2659577
Singapore	176452

BRISDELLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Brisdelle

Introduction

Brisdelle, a low-dose formulation of paroxetine, was approved by the FDA in June 2013 for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. This approval marked a significant event in the pharmaceutical industry, highlighting both the market dynamics and financial strategies employed by pharmaceutical companies.

FDA Approval and Market Entry

Brisdelle was cleared by the FDA despite an advisory committee recommending against it. This approval was for a new indication of paroxetine, which has been on the market since the mid-1990s as the antidepressant Paxil. The 7.5 mg formulation of Brisdelle is specifically designed for treating hot flashes in post-menopausal women, making it the first and only FDA-approved non-hormonal therapy for this condition[4].

Market Strategy: Extending Patent Life

The approval of Brisdelle exemplifies a common strategy in the pharmaceutical industry to extend the patent life and revenue of existing drugs. By obtaining FDA approval for a new indication or formulation, companies can create a new patent, preventing generic manufacturers from producing equivalent products. This tactic allows companies like Noven Pharmaceuticals to maintain market share and revenue from what is essentially an old product[1].

Financial Impact on Consumers

The financial implications for consumers are significant. Brisdelle, as a brand-name drug, is likely to be more expensive than the generic version of paroxetine. This higher cost is a result of the new patent protection, which prohibits generic competition. Clinicians have been prescribing paroxetine for hot flashes and other women's health issues for years, but the branded version, Brisdelle, will come at a higher price point[1].

Revenue and Profitability

The financial trajectory for Brisdelle is closely tied to its market strategy. The gain on the transfer of manufacturing and marketing approval of Brisdelle contributed significantly to the profitability of Noven Pharmaceuticals and its partners. For instance, Hisamitsu Pharmaceutical Co., Inc. reported an increase in profit attributable to the owners of the parent company mainly due to the gain from the transfer of Brisdelle's approval[2].

Industry Comparison: Pricing Strategies

The pricing strategy for Brisdelle mirrors broader industry practices. Companies like Celgene (now part of Bristol Myers Squibb) have been criticized for their aggressive price increases. For example, Celgene raised the price of Revlimid 22 times since its launch, resulting in a monthly cost that is more than triple the original price. This approach is driven by revenue and earnings goals, often at the expense of consumer affordability[3].

Media and Public Perception

The media coverage of Brisdelle's approval highlights the lack of critical analysis in pharmaceutical reporting. Many media outlets repeated press releases from Noven and the FDA without delving deeper into the implications of the new approval. This lack of scrutiny allows pharmaceutical companies to present old products as new, potentially misleading consumers about the novelty and value of the drug[1].

Clinical Significance and Market Demand

Brisdelle addresses a significant clinical need for non-hormonal treatments for VMS associated with menopause. The drug's approval was supported by Phase 3 pivotal trials presented at the North American Menopause Society (NAMS) meeting, demonstrating its efficacy in treating moderate to severe hot flashes. This clinical validation, combined with the lack of other non-hormonal options, positions Brisdelle to capture a substantial market share in this niche[4].

Competitive Landscape

In the competitive landscape of women's health and menopause treatments, Brisdelle faces competition from both hormonal and non-hormonal therapies. However, its unique status as the first FDA-approved non-hormonal therapy gives it a distinct advantage. The drug's once-daily dosing regimen also enhances patient compliance, a factor that can influence market preference[4].

Future Outlook and Financial Projections

The financial outlook for Brisdelle is promising, given its unique market position and the ongoing demand for menopause treatments. Noven Pharmaceuticals and its partners are likely to continue benefiting from the drug's patent protection, which will prevent generic competition for several years. This protection, combined with the drug's clinical efficacy, suggests sustained revenue and profitability for the foreseeable future[2].

Ethical Considerations

The approval and marketing of Brisdelle raise ethical questions about pharmaceutical pricing and the balance between corporate profits and consumer affordability. The practice of extending patent life through new indications or formulations can be seen as a way to maintain high prices, potentially limiting access to necessary medications for those who cannot afford them[1][3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Brisdelle. The FDA's approval process and the subsequent patent protection it affords are key factors in the drug's financial trajectory. Regulatory changes or increased scrutiny of pharmaceutical pricing practices could impact the future profitability of Brisdelle and similar drugs[1][3].

Key Takeaways

• Market Strategy: Brisdelle's approval exemplifies the strategy of extending patent life through new indications or formulations.
• Financial Impact: The drug is likely to be more expensive than generic paroxetine, affecting consumer affordability.
• Revenue and Profitability: The approval has significantly contributed to the profitability of Noven Pharmaceuticals and its partners.
• Clinical Significance: Brisdelle addresses a significant clinical need for non-hormonal treatments for VMS associated with menopause.
• Competitive Landscape: The drug's unique status as the first FDA-approved non-hormonal therapy gives it a market advantage.
• Future Outlook: The drug is expected to generate sustained revenue due to its patent protection and clinical efficacy.

FAQs

What is Brisdelle, and how is it different from other treatments for menopause symptoms?

Brisdelle is a low-dose formulation of paroxetine, specifically approved for treating moderate to severe vasomotor symptoms (VMS) associated with menopause. It is the first and only FDA-approved non-hormonal therapy for this condition.

Why is Brisdelle more expensive than generic paroxetine?

Brisdelle is more expensive because it is a brand-name drug with new patent protection, preventing generic competition. This protection allows the manufacturer to maintain higher prices.

How does the approval of Brisdelle reflect broader industry practices?

The approval of Brisdelle reflects the industry practice of extending patent life through new indications or formulations, a strategy used to maintain revenue and market share.

What are the clinical benefits of Brisdelle?

Brisdelle has been clinically proven to treat moderate to severe VMS associated with menopause, providing a non-hormonal treatment option. It has a once-daily dosing regimen, which enhances patient compliance.

How does the regulatory environment impact the market dynamics of Brisdelle?

The FDA's approval process and subsequent patent protection are crucial for Brisdelle's market dynamics. Regulatory changes could impact the drug's future profitability.

Sources

1. Columbia Journalism Review: "Flash: this new drug is not so new"
2. Hisamitsu Pharmaceutical Co., Inc.: "Corporate Vision - Annual Report 2017"
3. House Committee on Oversight and Reform: "Drug Pricing Investigation"
4. PR Newswire: "Data on Brisdelle™ (Paroxetine) Capsules, the First and Only FDA-Approved Non-Hormonal Therapy for Moderate to Severe Vasomotor Symptoms Associated with Menopause"