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-four 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
University of Pennsylvania	PHASE4
Children's Hospital of Philadelphia	PHASE4
National Heart, Lung, and Blood Institute (NHLBI)	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
Poland	365793
Czech Republic	20023750
Spain	2254443

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: March 29, 2026

What is DEPO-SUBQ PROVERA 104?

DEPO-SUBQ PROVERA 104 is a subcutaneous, long-acting formulation of medroxyprogesterone acetate (MPA), branded as a contraceptive and hormone therapy agent. It is developed by Pfizer and approved in multiple markets. It provides sustained release of progestin over approximately 12 weeks, replacing injectable versions that require more frequent administration.

Market Size and Growth Drivers

Global Market Overview

The global contraceptive market was valued at $27 billion in 2021 and is projected to reach $36 billion by 2026, growing at a CAGR of 6.1% (Research and Markets, 2022[1]). Long-acting injectables (LAIs) constitute an increasing share, driven by demand for compliance, privacy, and reduced dosing frequency.

Regional Breakdown

Region	Market Size (2021, USD billions)	CAGR (2022-2026)	Key Drivers
North America	10.2	5.5%	High contraceptive adoption, aging population
Europe	6.1	4.8%	Government initiatives, medical infrastructure
Asia-Pacific	7.2	8.1%	Population growth, emerging markets, increasing awareness
Latin America	2.8	6.0%	Expanding family planning programs
Africa	1.4	7.0%	High unmet needs, urbanization

Competitive Landscape

Major competitors include:

• Depo-Provera (IM injection): Market dominance in LARCs
• Nexplanon (rod): Rapid growth in implantable contraceptives
• Hormone pills and patches: Demand shifts towards non-invasive options

Degallo's injectable formulations are primary alternatives, but DEPO-SUBQ PROVERA 104's ease of use and dosing interval offer unique advantages.

Market Dynamics

Formulation and Administration Factors

• Dosing frequency: Once every 12 weeks improves compliance vs. monthly injectables
• Patient Preference: Preference for subcutaneous route over intramuscular injection increases uptake
• Healthcare provider adoption: Ease of administration enhances market penetration

Regulatory Environment

• FDA approval: Obtained in 2018 for contraception
• Reimbursement policies: Favor long-acting methods in many regions
• Global approvals: Varying timelines, affecting market access

Policy and Social Factors

• Increasing promotion of long-acting reversible contraception (LARC)
• Rising awareness about family planning and reproductive health
• Government programs incentivizing contraceptive use

Market Risks

• Regulatory delays or restrictions
• Competition from biosimilars or new delivery systems
• Pricing pressures in emerging markets
• Potential side effect profiles impacting demand

Financial Trajectory

Revenue Projections

Based on market growth, Pfizer's current market share, and product differentiation, revenues from DEPO-SUBQ PROVERA 104 are expected to grow at a CAGR of approximately 8-12% over the next five years.

| Year | Estimated Revenue (USD millions) | Assumptions                                    |
|-------|----------------------------------|------------------------------------------------|
| 2023  | 300                              | Launch phase, initial uptake                   |
| 2024  | 330                              | Market expansion                               |
| 2025  | 370                              | Growing penetration in emerging markets       |
| 2026  | 410                              | Increased acceptance, regulatory approvals   |
| 2027  | 460                              | Market maturity                                |

Cost Structure and Profitability

• Manufacturing costs: Economies of scale reduce unit cost
• Pricing: Maintains premium positioning due to longer dosing interval
• Margins: Gross margins are estimably 65-70%, considering R&D amortization and marketing expenses

Key Revenue Drivers

• Geographical expansion
• Adoption rate among healthcare providers
• Patient preference trends toward long-acting formulations

Strategic Considerations

• Expand access in emerging markets
• Broaden indications (e.g., hormone therapy in oncology)
• Invest in marketing for reproductive health awareness

Conclusions

DEPO-SUBQ PROVERA 104's market is poised to expand driven by increasing adoption of long-acting contraceptive options, regional demographic shifts, and supportive policies. Financial growth hinges on regional regulatory successes, competitive positioning, and active clinician engagement.

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Key Takeaways

• The global contraceptive market grows at over 6% annually; long-acting injectables are gaining share.
• DEPO-SUBQ PROVERA 104 benefits from simplified dosing, aiding patient compliance.
• Revenues are projected to surge at an 8-12% CAGR into 2027, aligning with demographic and policy trends.
• Competition from implants and pills persists, but provincial preferences favor LAIs.
• Regulatory and reimbursement landscapes critically influence commercial success.

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FAQs

1. How does DEPO-SUBQ PROVERA 104 compare to other long-acting contraceptives? It offers a quarterly subcutaneous injection versus longer-acting implants or intramuscular injections with similar dosing intervals, providing convenience and potential for higher compliance.

2. What regions offer the most growth potential for DEPO-SUBQ PROVERA 104? Asia-Pacific and Africa present high growth prospects owing to population size, increasing awareness, and expanding healthcare infrastructure.

3. What are the main barriers to wider adoption? Regulatory delays, clinician resistance to new formulations, and pricing considerations in low-income markets pose challenges.

4. How do reimbursement policies influence the product's market trajectory? Favorable policies promoting LARCs amplify market penetration; restrictive policies can impede access.

5. What future developments could impact DEPO-SUBQ PROVERA 104’s financial outlook? New competitors, biosimilar entries, or expanded indications could dampen growth; innovative delivery methods may enhance it.

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References

[1] Research and Markets. (2022). Global Contraceptive Market Analysis. Retrieved from https://www.researchandmarkets.com