BRISDELLE Drug Patent Profile

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

Brisdelle is a drug marketed by Legacy Pharma 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. Three 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:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	209
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

Pharmacology for BRISDELLE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

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
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	8,946,251		Y	Y
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	7,598,271			Y
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	9,393,237
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	8,658,663		Y	Y

Expired US Patents for BRISDELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	5,874,447
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	7,598,271

International Patents for BRISDELLE

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

Country	Patent Number	Title	Estimated Expiration
Spain	2155995
European Patent Office	1078925
Slovenia	0994872
Japan	5846717
Norway	995455
Iceland	7098

Market Dynamics and Financial Trajectory for BRISDELLE

Last updated: December 28, 2025

Executive Summary

BRISDELLE (estradiol/norethindrone acetate) is a hormone replacement therapy (HRT) approved primarily for postmenopausal women seeking relief from vasomotor symptoms and vulvar/vaginal atrophy. Despite a robust initial market presence, its growth trajectory faces challenges from evolving medical guidelines, competitive alternatives, and regulatory shifts. This report analyzes current market dynamics, revenue forecasts, competitive landscape, and strategic considerations pertinent to BRISDELLE, providing actionable insights for stakeholders.

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What Is BRISDELLE and How Does It Fit in the HRT Market?

BRISDELLE, developed by Kintara Therapeutics and marketed by Pfizer, combines estrogen (estradiol) with a progestin (norethindrone acetate) to mitigate risks associated with estrogen-only therapy. Approved by the U.S. Food and Drug Administration (FDA) in 2020, it caters to women with an intact uterus, addressing menopausal symptoms with a focus on safety and efficacy.

• Regulatory status: Approved for relief from moderate to severe vasomotor symptoms and vulvar/vaginal atrophy in menopausal women.
• Administration: Oral, daily.
• Pricing: Approximate wholesale price per month ranges from $130 to $160.

Marketed as an integrated therapy, BRISDELLE targets a large, aging female demographic, with the global postmenopausal women population expected to reach over 1.0 billion by 2030 ([2]).

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What Are the Key Market Drivers for BRISDELLE?

Demographics and Population Trends

Factor	Impact
Aging Population	Increased postmenopausal women globally (~600 million in 2023) spurs demand for HRT.
Women’s Health Awareness	Growing focus on quality of life and symptom management enhances market uptake.
General Healthcare Advancements	Improved diagnostics and better understanding of menopause expand treatment options.

Regulatory and Policy Influences

• FDA Guidance: Emphasis on personalized medicine and risk-benefit profiling influences prescribing patterns.
• Postmenopausal HRT Guidance: The North American Menopause Society (NAMS) recommends short-term use; growing awareness affects market size.
• Revised Risk Assessments: Increased emphasis on cardiovascular, breast cancer, and thrombotic risks may temper HRT adoption.

Competitive Landscape and Product Lifecycle

Competitor	Market Share (%)	Key Differentiator
Premarin (Conjugated Estrogens)	36%	Established brand, high familiarity
Femostil (Estradiol)	15%	Generic options available
Othrovis (Estradiol/norethindrone)	10%	Similar combined formulations
BRISDELLE	~5%	Recently launched, unique oral delivery

Market Penetration Considerations

• Physician Adoption: Physicians cautious owing to safety concerns; require endorsement by clinical guidelines.
• Patient Acceptance: Preference for non-hormonal alternatives and concerns over side effects.
• Insurance Coverage: Variability affects prescription rates.

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What Is the Financial Trajectory for BRISDELLE?

Revenue Projections and Market Share

Year	Estimated Global Market Size (USD)	BRISDELLE Market Share (%)	Projected Revenue (USD)	Notes
2023	3.2 billion	5%	$160 million	Initial launch phase; gaining awareness
2024	3.8 billion	6-8%	$228-304 million	Market expansion; increased physician familiarity
2025	4.5 billion	8-10%	$360-450 million	Competitive effects; ongoing marketing efforts
2030	6.0 billion	10-12%	$600-720 million	Growth driven by aging demographics and expanding indications

Factors Influencing Revenue

Positive Influencers	Negative Influencers
Rising menopausal population	Regulatory restrictions or contraindications
Increased awareness of HRT benefits	Concerns over safety and side effects
Strategic marketing & physician outreach	Competition from established generics and non-hormonal therapies
Expansion of indications (e.g., osteoporosis prevention)	Patent expiration, if applicable, leading to generic entry

Cost Considerations and Pricing Strategies

• Manufacturing costs: Estimated at $20–$30 per pack ([3]).
• Pricing strategies: Premium positioning versus competitive generic options.
• Rebate and discount trends: Affect net revenue realization.

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How Does the Competitive Landscape Impact BRISDELLE’s Market Dynamics?

Key Competitors and Differentiators

Competitor	Product Name	Formulation	Market Share	Key Features
Pfizer	BRISDELLE	Estradiol/Norethindrone	~5%	Novel oral combined therapy, first to market in this class
Novo Nordisk / Novo Nordisk	Estroven	OTC	N/A	OTC OTC supplements, non-prescription
Generic Manufacturers	Estradiol/Norethindrone	Various	20–30%	Lower-cost generic options

Recent Innovations and Emerging Therapies

• Non-hormonal options: SSRIs, SNRIs, and novel agents gaining traction.
• Biological agents: Ongoing research into tissue-specific estrogen receptor modulators (SERMs).
• Delivery systems: Transdermal patches, gels, and vaginal rings expanding choices.

SWOT Analysis of BRISDELLE

Strengths	Weaknesses
First oral estrogen-progestin combo approved	Limited awareness or clinical familiarity
Targeted therapy for women with uterus	Competition from established and emerging alternatives

Opportunities	Threats
Expanding indications (osteoporosis, vulvovaginal atrophy)	Regulatory restrictions or safety concerns
Growing global menopausal population	Patent expirations allowing generics entry

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What Are the Regulatory and Policy Trends Shaping BRISDELLE’s Future?

Regulatory Review and Post-Approval Monitoring

• FDA requirements: Post-marketing surveillance to monitor thrombotic and cancer risks ([4]).
• Label updates: Incorporation of risk management strategies.
• International markets: Varying approval statuses—e.g., EMA in Europe emphasizes individualized therapy, potentially affecting global sales.

Policy Changes

Policy Area	Impact
Healthcare reimbursement policies	Influences prescribing patterns and patient access
Menopause management guidelines	Can either promote or restrict HRT usage based on safety data
Data transparency mandates	Increased scrutiny of clinical trial data

How Will These Trends Affect Future Market Dynamics?

• Emphasis on personalized medicine may favor targeted therapies like BRISDELLE.
• A shift towards non-hormonal options could limit growth.
• Regulatory hurdles may delay or restrict market expansion in some regions.

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Summary of Key Market Opportunities and Challenges

Opportunities	Challenges
Growing postmenopausal demographic globally	Safety concerns associated with HRT use
Expansion into other indications (e.g., osteoporosis, vaginal Atrophy)	Competition from non-hormonal agents and generics
Increasing physician and patient awareness	Regulatory restrictions and evolving guidelines
Strategic partnerships and market penetration	Patent expirations leading to generic entry

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Key Takeaways

• Market Size & Growth: The global HRT market for menopausal women is projected to reach USD 6 billion by 2030, with BRISDELLE capturing a growing share owing to demographic shifts and strategic marketing.
• Competitive Position: BRISDELLE’s oral formulation and innovative combination offer differentiators, but primary competition remains from established generics and non-prescription supplements.
• Revenue Trajectory: Expected to surpass USD 600 million by 2030 if market penetration continues and indications expand.
• Strategic Focus: Building physician awareness, emphasizing safety profile, and expanding indications are vital for sustaining growth.
• Regulatory Outlook: Ongoing surveillance and evolving policies necessitate adaptive strategies to navigate safety concerns and approval pathways.

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FAQs

Q1: How does BRISDELLE compare to other hormone replacement therapies regarding safety?
BRISDELLE is designed with safety in mind through established dosing and combination. However, like all HRTs, it carries risks such as thromboembolism and breast cancer, necessitating careful patient selection and monitoring. Recent trials and real-world data continue to shape safety profiles.

Q2: What is the primary target demographic for BRISDELLE?
Postmenopausal women experiencing moderate to severe vasomotor symptoms and vulvar/vaginal atrophy, typically aged 50–60, with an intact uterus.

Q3: Are there any restrictions or contraindications associated with BRISDELLE?
Yes; contraindications include history of thromboembolic events, hormone-sensitive cancers, undiagnosed vaginal bleeding, and liver disease, aligned with existing HRT guidelines.

Q4: What are the prospects for BRISDELLE's expansion into other indications?
Potential exists for indications like osteoporosis prevention and genitourinary syndrome, but approval depends on clinical trial outcomes and regulatory assessments.

Q5: How might patent issues and generics impact BRISDELLE's long-term financial prospects?
Patent expirations could lead to generic competition, lowering prices and shrinking margins. Strategic patent protection and differentiation will be vital for sustained profitability.

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References

[1] FDA. (2020). BRISDELLE (estradiol/norethindrone acetate) approval letter. U.S. Food and Drug Administration.
[2] United Nations. (2023). World Population Prospects 2023. Department of Economic and Social Affairs.
[3] Industry Analysts. (2023). Pharmaceutical Manufacturing Cost Estimates.
[4] FDA. (2022). Menopause Guidance and Post-Marketing Surveillance.

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In conclusion, BRISDELLE’s positioning within the menopausal hormone therapy market is promising but requires strategic navigation amidst regulatory, competitive, and safety landscapes. Its growth is tethered to demographic trends, clinical acceptance, and proactive management of safety concerns, with significant upside if these factors align effectively.