CLIMARA Drug Patent Profile

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

Climara is a drug marketed by Bayer Hlthcare and is included in two NDAs.

The generic ingredient in CLIMARA is estradiol; levonorgestrel. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; levonorgestrel profile page.

Summary for CLIMARA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	28
Patent Applications:	3,868
Drug Prices:	Drug price information for CLIMARA
Drug Sales Revenues:	Drug sales revenues for CLIMARA
What excipients (inactive ingredients) are in CLIMARA?	CLIMARA excipients list
DailyMed Link:	CLIMARA at DailyMed

See drug prices for CLIMARA

See drug sales revenues for CLIMARA

Recent Clinical Trials for CLIMARA

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

Sponsor	Phase
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
Cystic Fibrosis Foundation	Phase 4

See all CLIMARA clinical trials

Pharmacology for CLIMARA

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for CLIMARA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLIMARA	Transdermal System	estradiol	0.05 mg/day and 0.1 mg/day	020375		2005-09-12

US Patents and Regulatory Information for CLIMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-004	Mar 5, 1999	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003		RX	Yes	Yes
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-006	May 27, 2003	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-001	Dec 22, 1994	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994	AB2	RX	Yes	Yes
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-003	Mar 23, 1998	AB2	RX	Yes	No

Expired US Patents for CLIMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-003	Mar 23, 1998	5,223,261
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-004	Mar 5, 1999	5,223,261
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994	5,223,261
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-006	May 27, 2003	5,223,261
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-001	Dec 22, 1994	5,223,261
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	5,223,261

International Patents for CLIMARA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H03502925
Netherlands	970007
Hong Kong	1006545
Austria	109357
World Intellectual Property Organization (WIPO)	8907951
Luxembourg	88849
Germany	68917292

Supplementary Protection Certificates for CLIMARA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLIMARA

Last updated: July 29, 2025

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Introduction

CLIMARA, a topical estrogen patch primarily used for hormone replacement therapy (HRT) in menopausal women, has established a significant footprint within the pharmaceutical landscape. Its unique mode of delivery and targeted indications have shaped its market evolution, influenced by broader demographic, regulatory, and healthcare trends. This report examines the current market dynamics and forecasts the financial trajectory of CLIMARA, providing insights vital for stakeholders in pharmaceutical investment, marketing, and R&D.

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Product Overview and Market Position

CLIMARA (estradiol transdermal system) delivers estrogen transdermally, offering an alternative to oral HRT with reduced hepatic first-pass effects, potentially lowering adverse events related to lipid metabolism and coagulation. Launched initially by Bayer (now part of Bayer AG), CLIMARA has maintained a competitive position against oral estrogen preparations, especially among women seeking non-invasive therapy options. Its emphasis on safety and convenience aligns with the preferences of a growing demographic seeking personalized menopausal management.

Key Market Drivers

1. Demographic Trends

   The global menopausal population is expanding due to increased life expectancy. According to the World Health Organization (WHO), by 2030, women aged 50+ will constitute over 20% of the global population. This demographic shift amplifies demand for safe and effective HRT options, positioning CLIMARA favorably.

2. Evolving Treatment Guidelines

   Contemporary guidelines favor transdermal estrogen for menopausal symptom management, especially in women with cardiovascular risks, due to its favorable safety profile [1]. Regulatory bodies like the U.S. FDA and EMA recognize transdermal formulations' benefits, incentivizing clinicians to prescribe products like CLIMARA.

3. Advancement in Formulation Technology

   Innovations in transdermal drug delivery enhance bioavailability, reduce side effects, and improve patient adherence. CLIMARA's design incorporates controlled-release technology, complementing its safety-centric profile, fostering sustained market interest.

4. Competitive Landscape

   The market features both branded products (e.g., Vivelle-Dot, Estraderm) and generics, intensifying price competition. However, CLIMARA's established brand recognition and physician familiarity mitigate commoditization risks.

5. Regulatory and Reimbursement Policies

   Reimbursement policies significantly influence utilization rates. In markets like the U.S. and Europe, inclusion in insurance formularies enhances access. Conversely, regulatory scrutiny surrounding HRT safety implications impacts prescribing patterns.

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Market Challenges and Barriers

• Safety Concerns and Litigation Risks

  Postmenopausal HRT's history is marred by safety debates, notably the Women's Health Initiative findings linking hormone therapy to increased risks of breast cancer, stroke, and cardiovascular events [2]. While transdermal estrogen like CLIMARA demonstrates a safer profile, ongoing litigation and public perception may temper growth.

• Pricing Pressures

  Growing availability of generics and biosimilars exerts downward pressure on prices, challenging profitability, particularly in mature markets.

• Market Saturation

  Established markets exhibit saturation, limiting growth potential without product innovations or new indications.

• Consumer Awareness and Preference

  Awareness campaigns and patient education influence market penetration. Misconceptions about hormone therapy's safety and efficacy hinder uptake.

Financial Trajectory and Revenue Forecasting

Current Revenue Landscape

While precise, up-to-date revenue figures for CLIMARA are proprietary, historical data underscores steady, albeit slow, growth within the global HRT market. The product's revenue contribution aligns proportionally with the broader transdermal estrogen segment, estimated to be valued at approximately USD 1.2 billion in 2022, rising at a CAGR of about 4% (2023–2030) [3].

Forecasting Trends

1. Short-term (1–3 years)

   • Moderate growth driven by demographic expansion and increased physician adoption.
   • Impact of COVID-19 remains a mitigating factor, but pent-up demand may accelerate uptake post-pandemic.
   • Price sensitivity and reimbursement policies may temper margins.

2. Medium-term (4–7 years)

   • Introduction of new formulations or combination therapies could elevate sales.
   • Enhanced marketing and physician education initiatives likely to bolster adoption.
   • Continuous safety data reaffirming estrogen therapy's benefits may expand indications.

3. Long-term (8+ years)

   • Market stabilization with potential plateauing unless innovation or expanded indications are achieved.
   • Competition from biosimilars or novel delivery systems could reshape landscape.
   • Digital health integration (e.g., adherence monitoring) may improve outcomes and retention.

Emerging Market Opportunities

Emerging markets offer considerable growth potential due to increasing awareness, rising healthcare infrastructure, and favorable regulatory reforms. Countries like China, India, and Brazil are witnessing exponential growth in menopausal care demand, with transdermal therapies like CLIMARA gaining prominence as cost-effective, patient-friendly options.

Strategic Considerations for Stakeholders

• Research and Development: Focus on innovating formulations—for instance, combination patches with testosterone or progestins—to expand indications.
• Regulatory Engagement: Navigating evolving safety standards and securing approvals for new markets or indications is critical.
• Market Penetration Strategies: Leveraging digital marketing, physician collaborations, and patient education can amplify penetration.
• Competitive Differentiation: Emphasize safety profile, convenience, and patient adherence advantages.

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Conclusion

The market dynamics for CLIMARA are shaped by demographic shifts, evolving treatment paradigms favoring transdermal estrogen, and regulatory environments emphasizing safety. While growth prospects appear steady in developed markets, challenges such as price competition, safety concerns, and saturation necessitate innovation and strategic agility.

Financially, CLIMARA's trajectory hinges on demographic trends, market innovations, and regulatory navigation. Its potential for sustained revenue growth remains, especially through expansion into emerging markets and product line extensions, provided manufacturers respond proactively to market shifts.

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Key Takeaways

• Demographic momentum and changing guidelines favor transdermal estrogen formulations, supporting CLIMARA’s sustained relevancy.
• Safety profile benefits and technological advances are primary differentiators amidst intense competition.
• Market growth is expected to be moderate in developed nations but robust in emerging markets.
• Pricing pressures and regulatory concerns warrant vigilant strategy adaptation.
• Innovation and market diversification (e.g., new formulations, indications) remain essential for long-term revenue prospects.

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FAQs

1. How does CLIMARA compare to oral estrogen therapies regarding safety?
Transdermal estrogen patches like CLIMARA bypass first-pass hepatic metabolism, reducing risks associated with hepatic protein synthesis, such as blood clotting and lipid abnormalities, making them safer options for women at cardiovascular risk [1].

2. What are the primary challenges facing CLIMARA's market expansion?
Major challenges include competition from generic formulations, evolving safety regulations, pricing pressures, and limited awareness in certain markets, particularly in developing countries.

3. Are there ongoing innovations related to CLIMARA?
Manufacturers are exploring combination patches, longer-acting formulations, and integrated digital adherence solutions to enhance efficacy and patient experience.

4. How has the COVID-19 pandemic impacted CLIMARA's market?
The pandemic disrupted routine healthcare access, causing temporary declines in prescriptions and manufacturing delays. However, the shift towards outpatient, self-administered treatments like patches mitigates long-term impact.

5. What regulatory trends could influence CLIMARA’s future?
Enhanced safety surveillance and preference for non-systemic therapies may prompt stricter guidelines and approval requirements, necessitating ongoing pharmacovigilance and data transparency.

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References

1. Maclennan AH, et al. (2017). Transdermal versus oral hormone replacement therapy: a systematic review. Menopause, 24(11), 1327–1334.
2. Rossouw JE, et al. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA, 288(3), 321–333.
3. MarketWatch. (2022). Global Transdermal Estrogen Market Size, Share & Trends Report.

Note: Data and projections are estimates based on current market reports and can vary depending on market developments.