MEDROXYPROGESTERONE ACETATE - Generic Drug Details

What are the generic drug sources for medroxyprogesterone acetate and what is the scope of patent protection?

Medroxyprogesterone acetate is the generic ingredient in seven branded drugs marketed by Pfizer, Amneal, Amphastar Pharms Inc, Cipla, Eugia Pharma, Hikma, Hong Kong, Sandoz, Sun Pharm, Teva Pharms Usa, Xiromed, Amarin Pharms, Solvay, Esi , Barr, Duramed Pharms Barr, and Upsher Smith Labs, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for medroxyprogesterone acetate. Twenty-four suppliers are listed for this compound.

Summary for MEDROXYPROGESTERONE ACETATE

US Patents:	0
Tradenames:	7
Applicants:	17
NDAs:	25
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	123
Patent Applications:	7,033
Drug Prices:	Drug price trends for MEDROXYPROGESTERONE ACETATE
What excipients (inactive ingredients) are in MEDROXYPROGESTERONE ACETATE?	MEDROXYPROGESTERONE ACETATE excipients list
DailyMed Link:	MEDROXYPROGESTERONE ACETATE at DailyMed

See drug prices for MEDROXYPROGESTERONE ACETATE

Recent Clinical Trials for MEDROXYPROGESTERONE ACETATE

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

Sponsor	Phase
Rajavithi Hospital	N/A
Bezmialem Vakif University	N/A
Oregon Health and Science University	Early Phase 1

See all MEDROXYPROGESTERONE ACETATE clinical trials

Pharmacology for MEDROXYPROGESTERONE ACETATE

Drug Class

Progestin

Medical Subject Heading (MeSH) Categories for MEDROXYPROGESTERONE ACETATE

Antineoplastic Agents, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Male

Contraceptives, Oral, Synthetic

Anatomical Therapeutic Chemical (ATC) Classes for MEDROXYPROGESTERONE ACETATE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

L02AB	Progestogens
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for MEDROXYPROGESTERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	076552-001	Oct 27, 2004		DISCN	No	No
Sun Pharm	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	210761-001	Apr 24, 2019		DISCN	No	No
Amneal	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	215397-001	Jun 7, 2023	AB	RX	No	No
Esi	CYCRIN	medroxyprogesterone acetate	TABLET;ORAL	081240-001	Oct 30, 1992		DISCN	No	No
Sun Pharm	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	210760-001	May 1, 2019		DISCN	No	No
Duramed Pharms Barr	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	TABLET;ORAL	040311-001	Dec 1, 1999		DISCN	No	No

Expired US Patents for MEDROXYPROGESTERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-002	Approved Prior to Jan 1, 1982	4,038,389
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583-001	Dec 17, 2004	6,495,534
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-003	Approved Prior to Jan 1, 1982	4,038,389

MEDROXYPROGESTERONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Medroxyprogesterone Acetate

Introduction to Medroxyprogesterone Acetate

Medroxyprogesterone acetate (MPA) is a synthetic progestin widely used in various medical applications, including contraception, hormone replacement therapy (HRT), and the treatment of several gynecological conditions. Its versatility and efficacy have made it a significant player in the pharmaceutical market.

Market Size and Projections

The global medroxyprogesterone acetate market has been valued at USD 257.3 million in 2023 and is projected to reach USD 339.6 million by 2031, growing at a compound annual growth rate (CAGR) of 3% from 2024 to 2031[1][3].

Segmentation of the Market

The market is segmented based on several key factors:

Application

• Contraception
• Hormone Replacement Therapy (HRT)
• Treatment of endometriosis
• Treatment of endometrial cancer
• Treatment of amenorrhea
• Treatment of abnormal uterine bleeding[1][3][5].

Product Formulations

• Oral tablets
• Injectable suspension
• Implants
• Topical creams[1][3].

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1][3][5].

Driving Factors

Several factors are driving the growth of the medroxyprogesterone acetate market:

Increasing Awareness of Women's Health

The growing awareness of women's health issues, particularly in developing regions, has led to an increased demand for effective treatments for gynecological conditions such as endometriosis and uterine fibroids[1].

Expanding Use in HRT

The use of medroxyprogesterone acetate in HRT for menopausal women is a significant driver. HRT helps manage symptoms like vasomotor symptoms, vulvar and vaginal atrophy, and osteoporosis, contributing to market growth[1][4].

Cost-Effective and Convenient Treatments

Studies have shown that oral medroxyprogesterone acetate can yield comparable outcomes to other treatments, such as GnRH antagonists, while reducing costs and the number of clinic visits per cycle. This makes it an attractive option for patients seeking cost-effective and convenient treatments, particularly in IVF cycles[2].

Pharmaceutical Research and Development

Continuous research and development in pharmaceuticals have led to new applications and formulations of medroxyprogesterone acetate, further boosting market growth. Positive regulatory approvals and advancements in treatment protocols also contribute to the market's upward trajectory[1].

Competitive Landscape

The competitive landscape of the medroxyprogesterone acetate market is characterized by:

Porter’s Five Forces Analysis

• Buyer bargaining power: Moderate due to the availability of various formulations and brands.
• Supplier bargaining power: Moderate, influenced by raw material costs and regulatory environments.
• Threat of new entrants: Low to moderate, given the established presence of major pharmaceutical companies.
• Threat of substitutes: Moderate, as other hormonal treatments are available.
• Degree of competition: High, with multiple players competing in the market[1].

Key Players and Market Ecosystem

The market includes system integrators, intermediaries, and end-users. Major pharmaceutical companies and generic drug manufacturers are key players, with a focus on innovation and market penetration[1].

Regional Analysis

The market is geographically segmented, with each region showing distinct trends:

North America

• This region is a significant market due to high awareness of women's health issues and advanced healthcare infrastructure[5].

Europe

• Europe also represents a substantial market, driven by the use of medroxyprogesterone acetate in HRT and gynecological treatments[5].

Asia-Pacific

• The Asia-Pacific region is expected to grow rapidly due to increasing healthcare spending and growing awareness of women's health[5].

Financial Performance and Projections

Revenue Growth

The market is expected to grow from USD 257.3 million in 2023 to USD 339.6 million by 2031, indicating a steady increase in revenue over the forecast period[1].

Cost Savings and Economic Impact

The use of medroxyprogesterone acetate, especially in IVF cycles, has been shown to reduce costs significantly. For instance, a study found an average cost savings of $491.06 per cycle compared to GnRH antagonists[2].

Challenges and Restraints

Despite the growth, the market faces some challenges:

Regulatory Environment

Changes in regulatory policies and stringent approval processes can impact market growth[1].

Side Effects and Adverse Reactions

Medroxyprogesterone acetate can have side effects, which may deter some patients and affect market demand. However, the benefits often outweigh the risks, especially with proper medical supervision[4].

Future Outlook

The future of the medroxyprogesterone acetate market looks promising due to:

Emerging Applications

Continued research is expected to uncover new applications and formulations, maintaining the market's growth trajectory[1].

Increasing Demand for HRT

The growing need for HRT among menopausal women will continue to drive demand for medroxyprogesterone acetate[1].

Global Health Initiatives

Global health initiatives focusing on women's health and reproductive health will further boost the market[5].

Key Takeaways

• The medroxyprogesterone acetate market is valued at USD 257.3 million in 2023 and is projected to reach USD 339.6 million by 2031.
• The market is driven by increasing awareness of women's health, expanding use in HRT, and cost-effective treatments.
• The competitive landscape is characterized by high competition and moderate bargaining power of buyers and suppliers.
• Regional analysis shows significant growth potential in North America, Europe, and the Asia-Pacific region.
• Despite challenges, the market is expected to grow steadily due to emerging applications and increasing demand for HRT.

FAQs

1. What are the primary applications of medroxyprogesterone acetate?

Medroxyprogesterone acetate is primarily used for contraception, hormone replacement therapy (HRT), treatment of endometriosis, endometrial cancer, amenorrhea, and abnormal uterine bleeding[1][3][4].

2. How does medroxyprogesterone acetate compare to other treatments in IVF cycles?

Medroxyprogesterone acetate yields comparable outcomes to GnRH antagonists in IVF cycles while reducing costs and the number of clinic visits per cycle[2].

3. What are the key drivers of the medroxyprogesterone acetate market?

The market is driven by increasing awareness of women's health, expanding use in HRT, cost-effective treatments, and continuous pharmaceutical research and development[1].

4. What are the potential side effects of medroxyprogesterone acetate?

Medroxyprogesterone acetate can have side effects such as weight gain, mood changes, and breast tenderness, among others. However, these are generally managed with medical supervision[4].

5. What is the projected CAGR for the medroxyprogesterone acetate market from 2024 to 2031?

The market is expected to grow at a CAGR of 3% from 2024 to 2031[1].

Cited Sources:

1. Market Research Intellect: Global Medroxyprogesterone Acetate Market Size and Forecast[1].
2. Endocrinology Advisor: Oral Medroxyprogesterone Acetate Yields Efficacious, Cost-Effective IVF Outcomes[2].
3. Market Research Intellect: Medroxyprogesterone Acetate Market Size And Forecast[3].
4. DrugBank: Medroxyprogesterone acetate: Uses, Interactions[4].
5. Cognitive Market Research: Medroxyprogesterone Acetate Market Report 2024 (Global Edition)[5].