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:	35
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	5,252,334
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	5,393,529
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
Australia	1652997
Austria	158181
Germany	59208918
Greece	3017851
New Zealand	235581	CONTROLLED RELEASE PLASTER COMPRISING A PRESSURE-SENSITIVE ACRYLIC/METHACRYLIC ACID POLYMER ADHESIVE WITH ACTIVE SUBSTANCES DISSOLVED THEREIN
Norway	920832
Spain	2078929

Supplementary Protection Certificates for CLIMARA PRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
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	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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Climara Pro

Introduction to Climara Pro

Climara Pro is a transdermal hormone therapy patch designed for postmenopausal women, combining estradiol and levonorgestrel. It is approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis in women with an intact uterus[5].

Market Need and Target Audience

The primary market for Climara Pro consists of postmenopausal women experiencing menopausal symptoms such as hot flashes and night sweats, as well as those at risk of osteoporosis. This demographic is significant, given the large number of women entering menopause each year.

Competitive Landscape

Climara Pro operates in a competitive market with various hormone therapy options available. Here are some key competitors:

• Estradiol-only formulations: Other estradiol patches like Alora, Climara, and Vivelle-Dot are alternatives but lack the combined estrogen-progestin therapy offered by Climara Pro[1].
• Combination therapies: Other combination hormone therapies, both oral and transdermal, compete with Climara Pro, but its once-weekly application and dual indication set it apart[5].

Clinical Efficacy and Safety

Climara Pro has demonstrated strong clinical efficacy in reducing menopausal symptoms and preventing osteoporosis. Clinical trials have shown that it rapidly and effectively controls hot flashes, with significant reductions observed as early as week one and sustained over 12 weeks. Additionally, it maintains bone mineral density at the lumbar spine and hip, outperforming placebo in these areas[5].

The safety profile of Climara Pro is also favorable, with low skin irritation rates and no significant impact on body weight. The incidence of endometrial hyperplasia is significantly lower with Climara Pro compared to estradiol-only treatments, making it a safer option for women with intact uteri[2].

Regulatory Approvals and Indications

Climara Pro received FDA approval in November 2003 for treating moderate to severe vasomotor symptoms associated with menopause. It was later approved in January 2006 for the prevention of postmenopausal osteoporosis[5].

Pricing and Cost Savings

The pricing of Climara Pro can be a significant factor in its market dynamics. The drug is available with cost-saving options, such as the Bayer Savings Card, which allows patients to pay as little as $25 per month, up to a maximum savings of $50 per month. This makes the treatment more accessible to a broader range of patients[4].

Financial Performance

The financial performance of Climara Pro is influenced by several factors, including market demand, competition, and pricing strategies.

• Revenue Growth: Given its dual indications and once-weekly application, Climara Pro has the potential for strong revenue growth. The demand for effective menopause treatments and osteoporosis prevention drives sales.
• Market Share: Climara Pro's unique combination of estradiol and levonorgestrel and its convenience of use help it maintain a significant market share in the hormone therapy segment.
• Cost Savings Programs: The availability of cost-saving programs enhances patient adherence and attracts more users, contributing to the drug's financial performance.

Patient Satisfaction and Adherence

Patient satisfaction is a crucial aspect of the financial trajectory of Climara Pro. With a positive effect reported by 45% of reviewers on Drugs.com, the drug has a moderate level of patient satisfaction. However, it is essential to note that patient satisfaction can vary, and ongoing support and education can improve adherence and overall satisfaction[1].

Market Trends and Future Outlook

The market for hormone therapies is evolving, with a growing focus on patient convenience, safety, and efficacy.

• Increasing Demand: The aging population and increasing awareness of menopausal symptoms and osteoporosis are expected to drive demand for Climara Pro.
• Technological Advancements: Advances in transdermal delivery systems could further enhance the convenience and efficacy of Climara Pro.
• Regulatory Environment: Changes in regulatory policies or new approvals for competing products could impact the market dynamics.

Challenges and Opportunities

Despite its strengths, Climara Pro faces several challenges:

• Competition: The presence of other hormone therapies and potential new entrants in the market poses a competitive threat.
• Side Effects: While Climara Pro has an acceptable side effect profile, any adverse reactions can impact patient adherence and market perception.
• Regulatory Scrutiny: Hormone therapies are under continuous regulatory scrutiny, and any changes in guidelines or safety concerns could affect sales.

However, there are also opportunities:

• Expanding Indications: Potential expansion of indications to other menopausal symptoms or conditions could increase market share.
• Global Market: Entering international markets can provide additional revenue streams.
• Patient Education: Enhancing patient education and support programs can improve adherence and satisfaction.

Key Takeaways

• Dual Indications: Climara Pro is uniquely positioned with dual indications for treating menopausal symptoms and preventing osteoporosis.
• Convenience: The once-weekly application makes it a convenient option for patients.
• Clinical Efficacy: Strong clinical efficacy in reducing hot flashes and maintaining bone mineral density.
• Cost Savings: Available cost-saving programs enhance patient accessibility.
• Market Trends: Growing demand driven by an aging population and increasing awareness of menopausal health.

FAQs

1. What are the primary indications for Climara Pro?

   • Climara Pro is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis in women with an intact uterus[5].

2. How often is Climara Pro applied?

   • Climara Pro is applied once weekly[4].

3. What are the key components of Climara Pro?

   • Climara Pro combines estradiol and levonorgestrel in a transdermal patch[5].

4. What are the common side effects of Climara Pro?

   • Common side effects include skin irritation, uterine bleeding or spotting, and other typical hormone therapy side effects. However, Climara Pro has an acceptable side effect profile[2].

5. Are there any cost-saving programs available for Climara Pro?

   • Yes, the Bayer Savings Card allows patients to pay as little as $25 per month, up to a maximum savings of $50 per month[4].

Sources

1. Drugs.com: Climara Pro Alternatives Compared.
2. FDA: Climara Pro Label.
3. Tandfonline.com: A combined, bioidentical, oral, 17β-estradiol and progesterone.
4. Climarapro.com: Save on Climara Pro.
5. Biospace.com: FDA Approves Osteoporosis Indication For Once-A-Week Hormone Therapy Patch Climara Pro.