PREMPHASE 14/14 Drug Patent Profile

Which patents cover Premphase 14/14, and what generic alternatives are available?

Premphase 14/14 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in PREMPHASE 14/14 is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for PREMPHASE 14/14

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	397
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREMPHASE 14/14
DailyMed Link:	PREMPHASE 14/14 at DailyMed

Pharmacology for PREMPHASE 14/14

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for PREMPHASE 14/14

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995		RX	Yes	Yes

Expired US Patents for PREMPHASE 14/14

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995

International Patents for PREMPHASE 14/14

See the table below for patents covering PREMPHASE 14/14 around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0722720
Hong Kong	1020282
Hungary	211971
Luxembourg	90343
Netherlands	980038
South Africa	9300746
Spain	2137627

Supplementary Protection Certificates for PREMPHASE 14/14

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0136011	SPC/GB00/025	United Kingdom		SPC/GB00/025: 20040802, EXPIRES: 20090801
0136011	SPC/GB97/032	United Kingdom		SPC/GB97/032: 20040802, EXPIRES: 20090801
0136011	SPC/GB98/034	United Kingdom		SPC/GB98/034: 20040802, EXPIRES: 20090801

Market Dynamics and Financial Trajectory for PREMPHASE 14/14

Introduction to PREMPHASE 14/14

PREMPHASE 14/14 is a hormonal therapy medication, specifically a combination of conjugated estrogens (CE) and medroxyprogesterone acetate (MPA), designed to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis. The therapy consists of two separate tablets: a maroon tablet containing 0.625 mg of CE taken orally on days 1 through 14, and a light-blue tablet containing 0.625 mg of CE plus 5 mg of MPA taken on days 15 through 28[3][5].

Market Overview

The market for hormonal replacement therapies (HRTs) like PREMPHASE 14/14 is influenced by several factors, including demographic changes, healthcare policies, and the availability of alternative treatments.

Demographic Factors

The increasing population of postmenopausal women is a significant driver for the demand of HRTs. As the global population ages, the need for treatments addressing menopausal symptoms and osteoporosis prevention is expected to rise.

Healthcare Policies and Regulations

Healthcare policies and regulatory environments play a crucial role in the market dynamics of pharmaceuticals. For instance, guidelines on the use of estrogen and progestin combinations, as well as reimbursement policies, can affect the prescription rates and sales of PREMPHASE 14/14[3].

Competitive Landscape

The HRT market is competitive, with various products available from different manufacturers. PREMPHASE 14/14 competes with other estrogen and progestin combination therapies, as well as non-hormonal treatments for menopausal symptoms and osteoporosis.

Financial Performance

Revenue Streams

The revenue generated by PREMPHASE 14/14 is part of the broader hormonal replacement therapy market. The sales figures are typically included in the financial reports of the manufacturing company, in this case, Pfizer.

• Sales by Region: The sales of PREMPHASE 14/14 are distributed across various regions, including the United States, Europe, and other international markets. The revenue can vary significantly based on regional demand, pricing, and market penetration[2].

• Product Portfolio: PREMPHASE 14/14 is one of the products within Pfizer's extensive portfolio of pharmaceuticals. The overall financial performance of Pfizer is influenced by the sales of all its products, including PREMPHASE 14/14.

Cost Structure

The cost structure for PREMPHASE 14/14 includes research and development expenses, manufacturing costs, marketing expenditures, and regulatory compliance costs.

• Research and Development: Continuous investment in R&D is crucial for maintaining market position and adapting to changing regulatory and clinical standards[2].

• Manufacturing and Distribution: The costs associated with producing and distributing the medication are significant and can be influenced by factors such as raw material prices and logistics.

Pricing Strategies

Pricing strategies for PREMPHASE 14/14 are influenced by market competition, regulatory approvals, and reimbursement policies.

• Competitive Pricing: The pricing of PREMPHASE 14/14 must be competitive with other HRT products in the market to maintain market share.

• Reimbursement Policies: The medication's pricing is also affected by healthcare reimbursement policies, which can vary by country and region[4].

Market Trends and Challenges

Safety and Efficacy Concerns

Safety and efficacy concerns have historically impacted the market for HRTs. Studies and clinical trials continue to monitor the long-term effects of estrogen and progestin combinations, which can influence prescribing practices and patient adherence[3].

Alternative Treatments

The availability of alternative treatments, both hormonal and non-hormonal, poses a challenge to the market share of PREMPHASE 14/14. Patients and healthcare providers may opt for other therapies based on efficacy, safety profiles, and personal preferences.

Regulatory Changes

Changes in regulatory guidelines can significantly impact the market dynamics. For example, updates in guidelines for the use of estrogen and progestin combinations can affect prescribing patterns and sales[3].

Future Outlook

Growth Opportunities

The growing population of postmenopausal women and the increasing awareness of menopausal health present growth opportunities for PREMPHASE 14/14.

• Emerging Markets: Expanding into emerging markets where access to HRTs may be limited can provide new revenue streams.

• Educational Campaigns: Educational initiatives aimed at healthcare providers and patients can increase awareness and adoption of the medication.

Challenges Ahead

Despite growth opportunities, several challenges need to be addressed:

• Competition: The competitive landscape of HRTs is expected to remain intense, with new products and formulations entering the market.

• Regulatory Compliance: Adhering to evolving regulatory standards and ensuring compliance with safety and efficacy guidelines will be crucial.

Key Takeaways

• PREMPHASE 14/14 is a combination HRT used to treat menopausal symptoms and prevent osteoporosis.
• The market is influenced by demographic changes, healthcare policies, and competitive dynamics.
• Financial performance is tied to broader pharmaceutical market trends and company-specific strategies.
• Safety and efficacy concerns, alternative treatments, and regulatory changes are key challenges.
• Growth opportunities exist in emerging markets and through educational campaigns.

FAQs

1. What is PREMPHASE 14/14 used for? PREMPHASE 14/14 is used to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis[3].

2. How is PREMPHASE 14/14 administered? PREMPHASE 14/14 consists of two separate tablets: a maroon tablet containing 0.625 mg of CE taken on days 1-14, and a light-blue tablet containing 0.625 mg of CE plus 5 mg of MPA taken on days 15-28[3].

3. What are the common adverse reactions to PREMPHASE 14/14? Common adverse reactions include abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, and leukorrhea[4].

4. Can PREMPHASE 14/14 be used for women at risk of osteoporosis? Yes, but it should only be considered for women at significant risk of osteoporosis, and non-estrogen medications should be carefully considered[5].

5. How does the competitive landscape affect PREMPHASE 14/14 sales? The competitive landscape, including other HRT products and non-hormonal treatments, can significantly impact the sales and market share of PREMPHASE 14/14.

Cited Sources

1. FDA Document: Prempro™ and Premphase® (conjugated estrogens and medroxyprogesterone acetate) NDA 020527Orig1s046[1].
2. Astellas Pharma Inc. Integrated Report 2022: Financial and non-financial information for Astellas Pharma Inc.[2].
3. Drugs.com: Premphase Prempro package insert / prescribing information[3].
4. Pfizer Medical Information: PREMPRO® AND PREMPHASE® (conjugated estrogens and medroxyprogesterone acetate)[4].
5. DailyMed: Conjugated estrogens and medroxyprogesterone acetate[5].