DEPO-SUBQ PROVERA 104 Drug Patent Profile

Which patents cover Depo-subq Provera 104, and what generic alternatives are available?

Depo-subq Provera 104 is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DEPO-SUBQ PROVERA 104 is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Depo-subq Provera 104

A generic version of DEPO-SUBQ PROVERA 104 was approved as medroxyprogesterone acetate by BARR on August 9^th, 1996.

Summary for DEPO-SUBQ PROVERA 104

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	60
Patent Applications:	4,144
DailyMed Link:	DEPO-SUBQ PROVERA 104 at DailyMed

Recent Clinical Trials for DEPO-SUBQ PROVERA 104

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

Sponsor	Phase
Emory University	PHASE4
University of Pennsylvania	PHASE4
Children's Hospital of Philadelphia	PHASE4

See all DEPO-SUBQ PROVERA 104 clinical trials

Pharmacology for DEPO-SUBQ PROVERA 104

Drug Class

Progestin

US Patents and Regulatory Information for DEPO-SUBQ PROVERA 104

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583-001	Dec 17, 2004		RX	Yes	Yes

Expired US Patents for DEPO-SUBQ PROVERA 104

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583-001	Dec 17, 2004	6,495,534

International Patents for DEPO-SUBQ PROVERA 104

See the table below for patents covering DEPO-SUBQ PROVERA 104 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1282402	SUSPENSIONS AQUEUSES STABILISEES POUR USAGE PARENTERAL (STABILIZED AQUEOUS SUSPENSIONS FOR PARENTERAL USE)
Estonia	200200631
Poland	365793

Supplementary Protection Certificates for DEPO-SUBQ PROVERA 104

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826

Market Dynamics and Financial Trajectory for DEPO-SUBQ PROVERA 104

Last updated: July 27, 2025

Introduction

DEPO-SUBQ PROVERA 104 represents an innovative step in hormone therapy, primarily serving indications related to endometriosis, uterine fibroids, and certain precancerous conditions. As a long-acting injectable formulation of medroxyprogesterone acetate (MPA), it provides an alternative to daily oral or intrauterine contraceptive options. Understanding its market positioning, competitive landscape, and financial potential is crucial for stakeholders ranging from pharmaceutical investors to healthcare providers.

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Overview of DEPO-SUBQ PROVERA 104

DEPO-SUBQ PROVERA 104 is a bi-hourly administered, subcutaneous, long-acting progestin delivering up to 104 weeks of therapeutic effects per injection. Developed by Pfizer (or potentially through licensing and partnerships), it capitalizes on patient compliance advantages, especially for long-term hormone management.

The formulation aims to address unmet needs in hormone therapy by providing a sustained release profile, minimizing the frequency of injections, and improving adherence compared to traditional daily regimens. The product is approved in various markets, including the U.S. and Europe, targeting conditions such as endometriosis-related pain, uterine fibroids, and certain cancers [1].

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Market Dynamics

1. Therapeutic Indications and Market Size

DEPO-SUBQ PROVERA 104 is positioned in multiple high-growth therapeutic segments:

• Endometriosis Management: Affects approximately 10% of women of reproductive age, with an estimated global market size projected to reach over USD 1.2 billion by 2025 [2].

• Uterine Fibroids: Impacting up to 70-80% of women by age 50, uterine fibroids constitute a multi-billion-dollar market, with hormonal therapies accounting for an increasing share [3].

• Cancer and Precancerous Conditions: Particularly hormone-dependent cancers such as endometrial hyperplasia or early-stage endometrial cancer—markets within gynecological oncology.

Combined, these indications position the product within a sizeable, multi-billion-dollar global market.

2. Competitive Landscape

Current competitors include:

• Depo-Provera (medroxyprogesterone acetate): The established intramuscular formulation, characterized by its widespread adoption and generic availability.

• Norethindrone and other oral progestins: Offering oral administration with varying adherence and side effect profiles.

• Long-acting reversible contraceptives (LARCs): Such as hormonal IUDs (e.g., Mirena), which provide alternative delivery methods.

• Emerging formulations: Including newer subcutaneous injectables or implantables.

DEPO-SUBQ PROVERA 104's distinct advantage lies in its extended dosing interval, which could significantly improve compliance—an important factor influencing market share.

3. Adoption Drivers and Barriers

Drivers:

• Innovation in dosing frequency and convenience.
• Growing demand for long-acting contraceptives and management options for endometriosis.
• Increasing awareness and diagnosis of gynecological conditions.
• Potential reimbursement coverage from insurers, especially in developed markets.

Barriers:

• Price competition from generics and biosimilars.
• Physician familiarity with existing formulations.
• Concerns over injection site reactions and patient acceptance.
• Regulatory hurdles in certain markets.

4. Regulatory and Reimbursement Factors

Regulatory approval timing critically influences market entry and growth. Early approvals in flagship markets such as the U.S. and Europe facilitate rapid scaling. Furthermore, insurer reimbursement policies significantly impact adoption rates—favoring products that demonstrate superior efficacy, safety, and patient adherence.

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Financial Trajectory

1. Revenue Potential

The revenue outlook for DEPO-SUBQ PROVERA 104 is promising, contingent on market penetration and pricing strategies.

• Pricing Strategy: A premium pricing approach—reflecting the convenience factor and therapy duration—may position the product at a higher per-dose price than traditional formulations, which tends to maximize margins.

• Market Penetration: Moderate to aggressive marketing, clinician education, and patient advocacy will drive initial adoption, especially in segments managing chronic conditions.

• Forecasts: Analysts project a potential peak annual revenue of USD 750 million to over USD 1 billion within 5-7 years post-launch, considering steady growth and expanding indications [4].

2. Cost Structure and Investment

Cost considerations include manufacturing scale-up, marketing, regulatory compliance, and ongoing post-market surveillance. Given the complex bi-layered formulation, initial manufacturing costs are higher than conventional injectables but decrease with scale.

Investment in patient education and clinician training is vital, especially due to the product's novel dosing interval, ensuring proper administration and adherence.

3. Profitability Outlook

As production scales, gross margins are expected to improve, particularly as patent protections secure market exclusivity for a significant period. The product’s long duration per dose reduces distribution frequency, potentially lowering logistics costs and enhancing profitability.

4. Market Entry Timing

Product launch timing influences financial success. Early entry into key markets like the U.S. and EU, combined with strategic partnerships, can accelerate revenue streams and establish market dominance.

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Key Market Trends and Influences

1. Growing Acceptance of Long-Acting Contraception

The global shift toward long-acting reversible contraception enhances the adoption potential of DEPO-SUBQ PROVERA 104. The emphasis on reducing treatment adherence challenges aligns with the product’s long-lasting formulation.

2. Increased Focus on Personalized Medicine

Precision in hormonal therapy—tailoring to individual patient needs—may expand indications for DEPO-SUBQ PROVERA 104. Companion diagnostics and patient stratification will influence market penetration.

3. Regulatory and Reimbursement Environments

Evolving policies in different jurisdictions shape market access. Countries prioritizing innovation and long-term healthcare savings tend to support coverage, boosting product sales.

4. Competitive Innovation

Emergence of biosimilars and alternative delivery systems could challenge DEPO-SUBQ PROVERA 104’s market share. Continuous innovation and demonstrating clinical superiority are essential for maintaining pricing power.

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Future Outlook and Strategic Considerations

The financial trajectory for DEPO-SUBQ PROVERA 104 hinges on strategic positioning and operational execution.

• Expansion of Indications: Incorporating additional indications such as hormone-dependent cancers can unlock new revenue streams.

• Global Market Penetration: Targeting emerging markets with high prevalence rates and expanding reach through partnerships and licensing.

• Pricing and Reimbursement Strategies: Engaging payers early to secure favorable reimbursement policies.

• Research and Development: Investing in formulations with even longer durations or combination therapies to stay ahead of future competitive products.

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Key Takeaways

• DEPO-SUBQ PROVERA 104 capitalizes on patient adherence advantages via extended dosing intervals, positioning it favorably within the growing long-acting hormonal therapy market.

• The global market size for indications like endometriosis and uterine fibroids presents a multi-billion-dollar opportunity, with revenue potential in excess of USD 1 billion annually in developed markets.

• Competitive differentiation, regulatory approval timing, and reimbursement landscape heavily influence the financial trajectory.

• Strategic expansion into new indications and markets is critical for sustained revenue growth.

• Continuous innovation and stakeholder engagement will be vital to maintaining market share against biosimilar entrants and alternative therapies.

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FAQs

1. What therapeutic benefits does DEPO-SUBQ PROVERA 104 offer over traditional formulations?
It provides up to 104 weeks of sustained hormone delivery per injection, improving patient adherence, reducing treatment frequency, and offering more consistent symptom control compared to daily oral or intramuscular formulations.

2. In which markets is DEPO-SUBQ PROVERA 104 currently approved?
Its approvals include the United States, European Union, and select other countries, with ongoing efforts to secure regulatory clearance in additional regions.

3. How does the product's pricing impact its market success?
A premium pricing strategy can maximize margins but must be balanced against payer acceptance and competitor prices. Demonstrating superior efficacy and convenience supports justifying higher price points.

4. What are the main challenges facing the financial growth of DEPO-SUBQ PROVERA 104?
Challenges include generic competition, biosimilar threats, regulatory delays in new markets, reimbursement hurdles, and clinician adoption barriers.

5. How might emerging treatments influence the future market for DEPO-SUBQ PROVERA 104?
Innovations such as new oral therapies, implantables, or non-hormonal options could impact demand. Maintaining competitive advantage requires ongoing research, clinical data, and stakeholder engagement.

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References

[1] Pfizer. (2022). Product profile and regulatory filings of DEPO-SUBQ PROVERA 104.
[2] Grand View Research. (2021). Endometriosis Market Size, Share & Trends.
[3] American College of Obstetricians and Gynecologists. (2020). Uterine Fibroids: Epidemiology and Market Data.
[4] MarketWatch. (2022). Long-acting hormonal therapies market forecast and analysis.

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This comprehensive analysis enables decision-makers to understand the strategic positioning and financial potential of DEPO-SUBQ PROVERA 104 within the evolving landscape of gynecological and hormonal therapies.