CLIMARA PRO Drug Patent Profile

Which patents cover Climara Pro, and what generic alternatives are available?

Climara Pro is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in CLIMARA PRO 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 PRO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	28
Patent Applications:	58
Drug Prices:	Drug price information for CLIMARA PRO
What excipients (inactive ingredients) are in CLIMARA PRO?	CLIMARA PRO excipients list
DailyMed Link:	CLIMARA PRO at DailyMed

See drug prices for CLIMARA PRO

Recent Clinical Trials for CLIMARA PRO

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

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

See all CLIMARA PRO clinical trials

Pharmacology for CLIMARA PRO

Drug Class	Estrogen Progestin Progestin-containing Intrauterine System
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

US Patents and Regulatory Information for CLIMARA PRO

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 PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003		RX	Yes	Yes

Expired US Patents for CLIMARA PRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003

International Patents for CLIMARA PRO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	960004300
Greece	3019124
Ireland	903259
Slovakia	279514
New Zealand	235068	TRANSDERMAL DRUG DELIVERY SYSTEM WITH THE DRUG DISPERSED IN A PRESSURE SENSITIVE ADHESIVE ACRYLATE POLYMER
Spain	2081352

Supplementary Protection Certificates for CLIMARA PRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLIMARA PRO

Last updated: July 28, 2025

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Introduction

CLIMARA PRO, a transdermal hormone replacement therapy (HRT) patch, combines estradiol and levonorgestrel to address menopausal symptoms and prevent endometrial hyperplasia in women. Since its approval, CLIMARA PRO has occupied a specific niche within the broader hormone therapy market, which is experiencing evolving demand dynamics influenced by regulatory, demographic, and scientific factors. This analysis explores the current market landscape, key drivers and barriers, and the financial trajectory potential for CLIMARA PRO.

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Market Landscape and Segmentation

The global hormone therapy (HT) market was valued at approximately USD 10 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4-6% through 2030 [1]. CLIMARA PRO competes primarily within the transdermal HRT segment, which offers advantages such as reduced hepatic first-pass metabolism and potentially lower risk profiles compared to oral formulations.

Segment-specific analysis indicates that postmenopausal women—estimated at over 1.2 billion globally—are the primary consumers. The increasing awareness and medical consultation rates enhance the adoption of prescribed HRT options, including patches like CLIMARA PRO.

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Market Dynamics

1. Demographic Shifts and Aging Population

The accelerated aging of the global population, particularly in North America and Europe, propels demand for menopause management solutions. Women aged 50–65 represent the core demographic. As life expectancy increases, an estimated 10-15% of this population will seek HRT during menopause, supporting sustained demand [2].

2. Rising Awareness and Healthcare Accessibility

Enhanced awareness about menopausal health and the benefits of HRT has contributed to higher acceptance and prescription rates. Additionally, expanding healthcare access—especially in emerging markets—facilitates broader product uptake.

3. Regulatory Environment and Prescribing Guidelines

Regulatory bodies like the FDA and EMA impose stringent guidelines on HRT products due to associated risks such as thromboembolism, breast cancer, and cardiovascular events. Recent updates have emphasized personalized therapy and risk stratification, influencing prescribing behaviors. CLIMARA PRO’s safety profile, bolstered by clinically supported transdermal administration, positions it favorably amid these shifting standards.

4. Competitive Landscape

The market features oral pills, gels, vaginal rings, and patches—each with specific advantages. Major competitors include EstroGel, Femring, and other branded patches. CLIMARA PRO’s unique formulation and drug delivery system distinguish it, but price competition and insurer coverage impact market share.

5. Scientific and Clinical Trends

Emerging data underscores the safety benefits of transdermal estrogen delivery—less hepatic impact and potentially lower thrombotic risk—enhancing CLIMARA PRO’s positioning. However, safety concerns related to prolonged HRT use continue to influence usage patterns.

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Financial Trajectory and Growth Drivers

1. Revenue Potential and Market Penetration

While CLIMARA PRO currently holds a niche position, its revenue trajectory hinges on market penetration and acceptance. Assuming a conservative share capture within the transdermal HRT segment—projected at 15-20% over five years—the product could generate significant revenues [3].

2. Pricing Strategies and Reimbursement

Pricing varies across markets, with premium positioning in developed countries. Reimbursement coverage and insurance policy alignment significantly determine accessibility. Pricing flexibility and differentiation based on formulary status influence revenue flows.

3. Strategic Marketing and Physician Adoption

Intensive physician education and marketing bolster prescriber confidence. Demonstrating superior safety profiles and patient convenience can increase prescription volumes, directly impacting revenue growth.

4. Regulatory Approvals and Geographic Expansion

Expanding indications, such as use in younger women with specific hormonal deficiencies, could diversify revenue streams. Additionally, gaining approval in emerging markets offers high-growth opportunities due to unmet needs and rising healthcare investments.

5. Impact of Patent and Regulatory Exclusivities

Patent protection and data exclusivity periods will influence pricing power and market exclusivity. Once expired, generic competitors could erode margins, underscoring the importance of lifecycle management strategies.

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Challenges and Risks

• Safety and Litigation Risks: Past litigations related to HRT have heightened caution among clinicians and regulators.
• Market Saturation: Existing competition and minimal differentiation can limit growth.
• Regulatory Hurdles: Stringent approval pathways might delay market expansion.
• Pricing Pressures: Healthcare cost containment measures influence product profitability.

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Future Outlook

The prospects for CLIMARA PRO hinge on strategic positioning within the evolving HT landscape. Its key advantages—minimal hepatic metabolism, ease of use, and safety profile—are vital for capturing more prescriber and patient interest. Continuous clinical validation and proactive regulatory and market strategies are critical to achieving sustained growth.

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Key Takeaways

• Demographic Trends: An aging female population ensures ongoing demand, particularly in developed markets.
• Clinical Advantages: Transdermal delivery’s safety benefits position CLIMARA PRO favorably amidst safety concerns over oral HRT.
• Market Penetration: Growth depends on expanding prescriber awareness, reimbursement, and geographic reach.
• Competitive Strategies: Differentiating through safety, efficacy, and patient-centric features will influence market share.
• Regulatory Landscape: Navigating complex approval processes and patent protections will shape revenue trajectories.

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FAQs

Q1: How does CLIMARA PRO differ from other HRT options?
A1: CLIMARA PRO offers transdermal delivery of estradiol and levonorgestrel, providing potentially lower risks of thromboembolism and hepatic impact compared to oral counterparts, with convenience in patch form.

Q2: What are the primary growth drivers for CLIMARA PRO?
A2: Increasing menopausal population, rising awareness of HRT benefits and safety, favorable scientific evidence for transdermal delivery, and expanding healthcare access globally.

Q3: What regulatory challenges could impact CLIMARA PRO’s market growth?
A3: Stringent safety assessments, compliance with evolving guidelines, and potential delays in approval processes in new markets could limit rapid expansion.

Q4: How does pricing impact CLIMARA PRO’s market penetration?
A4: Competitive pricing and favorable insurance coverage are crucial for adoption in cost-sensitive markets, especially in countries with strict healthcare budgets.

Q5: What strategic steps can enhance CLIMARA PRO’s financial trajectory?
A5: Broadening indications, expanding into emerging markets, engaging in physician education, leveraging clinical data for safety and efficacy, and optimizing reimbursement pathways.

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References

[1] MarketsandMarkets. "Hormone Replacement Therapy Market by Product, Application, and Region." 2022.
[2] World Health Organization. "Menopause and Ageing." 2021.
[3] IQVIA. "Global Market Report on Menopause Management Drugs." 2022.