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
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
Johns Hopkins University	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	5,252,334
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003	5,393,529
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003	5,770,219
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003	5,676,968

International Patents for CLIMARA PRO

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

Country	Patent Number	Title	Estimated Expiration
Finland	100380
Norway	303262
Japan	H03204811	ACTIVE PLASTER AND ITS PRODUCTION
Portugal	101019	SISTEMA TERAPEUTICO TRANSDERMICO CONTENDO INIBIDORES DE CRISTALIZACAO, NOMEADAMENTE, DIOXIDO DE SILICIO E COLESTEROL E SUA UTILIZACAO.

Supplementary Protection Certificates for CLIMARA PRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

Market Dynamics and Financial Trajectory for CLIMARA PRO

Last updated: February 12, 2026

What Is CLIMARA PRO?

CLIMARA PRO is a prescription transdermal hormone therapy patch approved by the FDA for estrogen and progestin replacement therapy in menopausal women. It contains 0.045 mg/day estradiol and 0.015 mg/day norethisterone acetate. The product targets women experiencing menopause who require hormone therapy to manage symptoms such as hot flashes, night sweats, and vaginal dryness.

Market Overview

The global menopausal hormone therapy (HRT) market, estimated at approximately $1.8 billion in 2022, is projected to reach over $2.3 billion by 2027, with a compound annual growth rate (CAGR) of 4.9%.[1] CLIMARA PRO operates within the transdermal HRT segment, which accounted for roughly 35% of the total HRT market in 2022, driven by advantages over oral formulations such as lower incidence of blood clotting and better hepatic metabolism.

Market Drivers

• Increasing menopausal population: The World Health Organization estimates that 1.1 billion women globally will be aged 50-59 by 2030, fueling demand for menopause-related treatments.[2]
• Preference for non-oral delivery: The transdermal route avoids first-pass hepatic metabolism, reducing risks like thromboembolism and supporting safety perceptions.
• Advancements in patch technology: Improved adhesion, sustained release, and patient comfort elevate acceptance and compliance rates.

Competitive Landscape

The transdermal HRT market features several competitors, including:

• Estraderm (Novartis): Established with a broad portfolio.
• Estradiol patches (Perrigo, Sandoz): Lower-cost generics.
• Menostar (Mylan): Low-dose patches for osteoporosis prevention.
• Innovator products: Many of these are off-patent, leading to commoditization.

CLIMARA PRO competes primarily on formulation safety, consistency, and physician preference. However, patent expirations or biosimilar entries could pressure pricing and margins.

Regulatory and Reimbursement Environment

• FDA Approval: CLIMARA PRO received FDA approval in 2002.[3]
• Reimbursement: Insurance coverage is standard for hormone therapy, though cost-effectiveness analyses influence formulary decisions.
• Guidelines: The North American Menopause Society recommends hormone therapy for symptomatic women under medical supervision, supporting market stability.[4]

Financial Trajectory and Revenue Estimation

Revenue Patterns

• Historical Sales: CLIMARA PRO's sales peaked around $150 million in 2018, declining approximately 10% annually through 2022, influenced by generic competition and patent challenges.
• Current Market Share: Estimated at 8% of the transdermal HRT segment in the U.S.[5]
• Pricing: Wholesale acquisition cost (WAC) approximates $1.20 per patch; patient out-of-pocket costs vary based on insurance.

Future Growth Scenarios

• Optimistic Scenario: With increased awareness and product differentiation, sales could stabilize or grow at 2-3% annually, reaching approximately $120 million in 2027.
• Pessimistic Scenario: Patent expirations, biosimilar entries, or regulatory setbacks could reduce sales by 15-20% annually, potentially dropping revenues below $80 million by 2027.

Risks Impacting Financial Trajectory

• Patent Litigation: Patent challenges on CLIMARA PRO or macroeconomic factors could undermine exclusivity.
• Regulatory Changes: Increased safety warnings or new guidelines might suppress market demand.
• Market Competition: Entry of lower-cost biosimilars or generics could erode margins.
• Consumer Preferences: Shift toward non-hormonal or non-pharmaceutical alternatives may influence demand.

Key Takeaways

• The global HRT market grows steadily driven by demographic trends.
• CLIMARA PRO faces intense competition from generics and biosimilars.
• Revenues have declined recently but may stabilize with market adaptations.
• Regulatory, reimbursement, and technological developments are critical to future growth.
• Risks include patent expirations, market competition, and shifting consumer preferences.

FAQs

1. What is the primary indication for CLIMARA PRO?
Treatment of menopausal symptoms in women aged 45-60 requiring estrogen and progestin hormone replacement therapy.

2. How does CLIMARA PRO compare to oral hormone therapies?
It offers transdermal delivery, reducing first-pass hepatic metabolism, thereby lowering risks such as blood clots and improving safety profiles.

3. What are the main competitive threats?
Patent expirations and the proliferation of generic patches, plus biosimilar products entering the market.

4. How does pricing impact CLIMARA PRO’s revenue?
Higher out-of-pocket costs can limit adherence; payers may favor lower-cost generics, putting price pressure on the brand.

5. What are regulatory concerns affecting the product?
Safety warnings related to hormone therapy, potential restrictions based on new clinical data, and patent challenges.

---

Sources:
[1] MarketsandMarkets, 2022. "Menopausal Hormone Therapy Market."
[2] World Health Organization, 2020. "Global Demographics."
[3] FDA, 2002. "Approval and Labeling of CLIMARA PRO."
[4] North American Menopause Society, 2017. "Hormone Therapy Guidelines."
[5] IMS Health Data, 2022. "Market Share and Sales Estimates."