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:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	28
Patent Applications:	4,221
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

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

International Patents for CLIMARA

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	970007
Luxembourg	88849
Australia	630347

Supplementary Protection Certificates for CLIMARA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0770388	PA2009004,C0770388	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
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306

CLIMARA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLIMARA

Introduction to CLIMARA

CLIMARA is a transdermal patch containing the active ingredient estradiol, used primarily for the treatment of menopausal symptoms due to estrogen deficiency. It is an adhesive patch that delivers estradiol through the skin and into the bloodstream, providing a continuous and controlled release of the hormone[2][5].

Market Overview

The US transdermal patch market, which includes products like CLIMARA, is expected to experience significant growth driven by technological innovations and increasing acceptance of patch drug delivery methods. The market is projected to surpass $6 billion in the next few years, with a strong clinical pipeline and numerous FDA-approved patches already available[1].

Clinical and Regulatory Landscape

As of the latest reports, more than 25 FDA-approved transdermal patches are available in the US market, and over 40 are in clinical trials. CLIMARA itself has been FDA-approved since 1994 and is available in various strengths, including 0.025mg/24hr, 0.05mg/24hr, 0.075mg/24hr, 0.0375mg/24hr, and 0.06mg/24hr[4].

Market Dynamics

Favorable Market Parameters

• Technological Advancements: Continuous research and development in transdermal patch technology have improved the efficacy and convenience of these products, driving market growth.
• Non-Invasive Method: The non-invasive nature of transdermal patches, which avoid the gastrointestinal tract and liver, makes them a preferred option for many patients[1].
• Diverse Indications: Transdermal patches like CLIMARA are used for various conditions, including menopausal symptoms, Parkinson's disease, Alzheimer's disease, nicotine replacement therapy, and cardiovascular diseases, expanding their market reach[1].

Commercialization Challenges

• Regulatory Hurdles: The process of obtaining FDA approval can be lengthy and costly, posing a challenge for new entrants in the market.
• Competition: The market is highly competitive with numerous established players, making it challenging for new products to gain significant market share[1].

Financial Trajectory

Revenue Projections

The US transdermal patch market, including products like CLIMARA, is expected to see substantial revenue growth. The market's opportunity is driven by the increasing demand for convenient and effective drug delivery systems. With over $6 billion in projected revenue in the coming years, the financial outlook for CLIMARA and similar products is promising[1].

Generic Competition

While CLIMARA is a branded product, the availability of generic versions can impact its market share. However, the brand's established reputation and the specific formulation of CLIMARA continue to support its market position[4].

Competitive Landscape

CLIMARA operates in a competitive market with several other transdermal patch products. The competitive landscape is characterized by:

• Established Players: Companies like Bayer Healthcare, the manufacturer of CLIMARA, have a strong presence in the market.
• Innovative Products: New entrants and existing players are continuously developing innovative transdermal patch products, which can challenge CLIMARA's market share[1].

Clinical Pipeline and Future Prospects

The robust clinical pipeline for transdermal patches, including those for diseases like cancer, Parkinson's disease, and Alzheimer's disease, indicates a bright future for products like CLIMARA. The ongoing research and development are expected to yield more specific and effective treatments, further solidifying the market position of transdermal patches[1].

Risk Factors and Safety Considerations

While CLIMARA offers several benefits, it also comes with certain risk factors, such as an increased risk of blood clots, coronary heart disease, and gall bladder disease. These risks must be carefully managed and communicated to patients to ensure safe use[2][5].

Key Takeaways

• Market Growth: The US transdermal patch market, including CLIMARA, is expected to grow significantly, driven by technological innovations and increasing acceptance.
• Regulatory Approval: CLIMARA has been FDA-approved since 1994 and is available in various strengths.
• Competitive Landscape: The market is highly competitive, but CLIMARA's established reputation supports its market position.
• Future Prospects: The robust clinical pipeline indicates a promising future for transdermal patches.
• Risk Factors: Patients must be aware of the potential risks associated with using CLIMARA.

Frequently Asked Questions

Q1: What is CLIMARA used for? CLIMARA is used for the treatment of menopausal symptoms due to estrogen deficiency during menopause or after a surgical procedure where estrogen production is decreased[2].

Q2: How does CLIMARA work? CLIMARA is an adhesive patch that delivers estradiol through the skin and into the bloodstream, providing a continuous and controlled release of the hormone[2].

Q3: What are the potential risks associated with using CLIMARA? Using CLIMARA may increase the risk of blood clots, coronary heart disease, gall bladder disease, and other conditions. It is important to discuss these risks with a healthcare provider[2][5].

Q4: Is CLIMARA available in generic form? Yes, generic versions of CLIMARA are available, which can impact the market share of the branded product[4].

Q5: What is the projected market size for transdermal patches like CLIMARA? The US transdermal patch market is projected to surpass $6 billion in the next few years, driven by technological innovations and increasing acceptance[1].

Sources:

1. United States Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2026 - ResearchAndMarkets.com
2. CLIMARA - NPS MedicineWise
3. TXMD Overview - TherapeuticsMD Inc
4. Generic Climara Availability - Drugs.com
5. Climara (Estradiol Transdermal System) - FDA