You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 29, 2025

Medroxyprogesterone acetate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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-six suppliers are listed for this compound.

Summary for medroxyprogesterone acetate
Drug Prices for medroxyprogesterone acetate

See drug prices for medroxyprogesterone acetate

Recent Clinical Trials for medroxyprogesterone acetate

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

SponsorPhase
Rajavithi HospitalN/A
Bezmialem Vakif UniversityN/A
Oregon Health and Science UniversityEarly Phase 1

See all medroxyprogesterone acetate clinical trials

Pharmacology for medroxyprogesterone acetate
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for medroxyprogesterone acetate

US Patents and Regulatory Information for medroxyprogesterone acetate

Showing 1 to 5 of 5 entries

Expired US Patents for medroxyprogesterone acetate

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Pfizer DEPO-PROVERA medroxyprogesterone acetate INJECTABLE;INJECTION 012541-002 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
Pfizer DEPO-PROVERA medroxyprogesterone acetate INJECTABLE;INJECTION 012541-003 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
Pfizer DEPO-SUBQ PROVERA 104 medroxyprogesterone acetate INJECTABLE;SUBCUTANEOUS 021583-001 Dec 17, 2004 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Medroxyprogesterone Acetate

Last updated: July 27, 2025

Introduction

Medroxyprogesterone acetate (MPA) is a synthetic progestin widely used in various medical applications, including contraception, hormone replacement therapy, and the treatment of certain gynecological conditions. As a versatile and long-established pharmaceutical agent, the drug’s market landscape is shaped by evolving clinical landscape, regulatory milestones, emerging competitors, and demographic shifts. This analysis explores the current market dynamics and forecasts the financial trajectory of MPA over the next decade.

Market Overview

The global market for medroxyprogesterone acetate encompasses multiple segments:

  • Contraceptive Use: MPA is primarily available as a long-acting injectable contraceptive, notably under brand names like Depo-Provera.
  • Hormone Therapy: Used in hormone replacement therapy (HRT) for menopausal symptoms.
  • Gynecological and Oncological Indications: Prescribed for treatment of endometriosis, uterine bleeding, and as part of cancer therapy protocols.

According to a report by Grand View Research, the global progestin market was valued at approximately USD 3.9 billion in 2021, with MPA constituting a significant share due to widespread adoption in contraceptive schemes [1].

Market Dynamics

1. Clinical and Demographic Drivers

  • Population Growth and Aging: Increasing global population, especially in developing economies, widens the patient base. The aging population's prevalence of hormone-related conditions sustains demand for MPA in HRT.
  • Reproductive Healthcare Trends: Growing acceptance of long-acting reversible contraceptives (LARCs) fuels sales of injectable contraceptives like Depo-Provera. Female empowerment and improved reproductive health awareness accelerate adoption.
  • Medical Guidelines and Physician Preferences: Established safety profiles foster continued clinical use; however, the emergence of alternative contraceptives influences prescribing patterns.

2. Regulatory Landscape

  • Approval Status: MPA enjoys regulatory approval in various jurisdictions for contraception and HRT, including FDA approval for Depo-Provera since 1992. However, regulatory modifications, such as restrictions or label updates, can impact market access.
  • Patent Expiry and Generic Competition: The original patents for Depo-Provera expired in several markets, leading to increased generic manufacturing which exerts downward pressure on prices and corporate revenues.

3. Competitive Environment

  • Emerging Alternatives: New contraceptive methods, including intrauterine devices (IUDs), implants, and non-hormonal options, challenge MPA’s market dominance.
  • Biosimilar and Generic Players: The entrance of biosimilar formulations reduces costs and enhances accessibility, especially in low- and middle-income countries (LMICs).

4. Supply Chain and Manufacturing Factors

  • Production Costs: Advances in manufacturing streamline production, but global supply chain disruptions (e.g., during the COVID-19 pandemic) have temporarily affected availability.
  • Price Sensitivity: Pricing strategies influence procurement, especially in public health initiatives and LMICs, where cost-effectiveness is pivotal.

5. Market Challenges

  • Safety Concerns: Adverse effects such as osteoporosis, weight gain, and potential links to breast cancer have led to some regulatory scrutiny and cautious prescribing practices.
  • Vaccine and Pandemic Impacts: Global health emergencies influence healthcare resource allocation and patient access to medication.

Financial Trajectory and Market Forecast

Historical Performance

From 2015 to 2021, the MPA market experienced consistent growth, primarily driven by increased contraceptive coverage and the drug's longstanding familiarity. The global market for injectable contraceptives, dominated by Depo-Provera, grew at a CAGR of approximately 4.2% during this period [1].

Projected Trends (2022–2032)

  • Compound Annual Growth Rate (CAGR): The global MPA market is projected to expand at a CAGR of 3.5%–4.0%, reaching an estimated USD 5.5 billion by 2032.
  • Regional Market Dynamics:
    • North America & Europe: Market saturation respective to high contraceptive adoption; growth driven by demographic shifts and reformulation of guidelines.
    • Asia-Pacific: Expected to exhibit the highest growth (CAGR ~5%) owing to expanding reproductive healthcare infrastructure, increased awareness, and government-led family planning initiatives.
    • Latin America & Africa: Growing markets, particularly in LMICs, where affordability and accessibility initiatives bolster demand.

Key Revenue Drivers

  • Introduction of Long-Acting Formulations: Extended-release injectables with improved safety profiles are expected to command premium pricing.
  • Government & NGO Funding: Public health programs and international agencies' support in family planning initiatives will sustain demand.
  • Expanding Indications: Application in hormonal therapy and off-label uses could broaden revenue opportunities.

Risks and Uncertainties

  • Regulatory Changes: Potential bans or restrictions due to safety concerns could sharply diminish revenue streams.
  • Competition and Innovation: Introduction of more effective or safer contraceptive modalities could erode market share.
  • Economic Factors: Price sensitivities and healthcare spending fluctuations, particularly in LMICs, may influence adoption rates.

Strategic Implications

  • Invest in Bioavailability and Safety Improvements: Developing formulations with minimized adverse effects can sustain market relevance.
  • Expand Access in Emerging Markets: Strategic partnerships and licensing agreements can capitalize on demographic trends.
  • Monitor Regulatory Changes: Proactive engagement with regulatory authorities ensures compliance and facilitates market expansion.

Conclusion

Medroxyprogesterone acetate continues to hold a vital position within reproductive health options globally. While facing challenges from newer contraceptive modalities and regulatory considerations, its entrenched clinical utility secures steady, modest growth. The expanding healthcare infrastructure in emerging markets, combined with policy support for family planning, indicates a stable but competitive financial outlook over the next decade.


Key Takeaways

  • Market Stability with Moderate Growth: The MPA market is projected to grow at 3.5–4.0% CAGR, driven by demographic and healthcare infrastructure factors.
  • Competitive and Regulatory Risks: Patent expiries, generic competition, and safety concerns necessitate ongoing innovation and regulatory vigilance.
  • Emerging Markets as Growth Catalysts: Asia-Pacific and LMICs present significant opportunities for expansion, with tailored pricing and access strategies.
  • Diversification Opportunities: Expanding indications beyond contraception could diversify revenue streams.
  • Strategic Focus: Companies should prioritize safety profile improvements, foster partnerships, and monitor regulatory trends to sustain market relevance.

FAQs

1. What are the primary indications for medroxyprogesterone acetate?
Medroxyprogesterone acetate is mainly used for injectable contraception (Depo-Provera), hormone replacement therapy, and treatment of certain gynecological conditions like abnormal uterine bleeding and endometriosis.

2. How does patent expiry impact the MPA market?
The expiration of patents for branded formulations like Depo-Provera has led to increased generic availability, resulting in price competition and potential market share redistribution.

3. What are the main competitors to MPA-based contraceptives?
Alternatives include intrauterine devices (IUDs), implants, hormonal patches, and non-hormonal methods, which may offer benefits like fewer side effects or longer duration.

4. How do safety concerns influence the market?
Adverse effects such as weight gain, osteoporosis, and potential links to breast cancer have prompted regulatory review and cautious prescribing, potentially limiting market growth.

5. What future innovations could affect MPA’s market outlook?
Development of longer-acting, safer formulations, biodegradable delivery systems, and combination therapies could enhance MPA’s competitiveness and expand its applications.


References

[1] Grand View Research. "Progestin Market Size & Trends," 2022.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.