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:	78
Clinical Trials:	59
Patent Applications:	4,288
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
Oregon Health and Science University	Early Phase 1
Canadian Institutes of Health Research (CIHR)	Phase 4
Canadian Cancer Society (CCS)	Phase 4

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

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
Germany	60116084
Austria	313316
European Patent Office	1282402	SUSPENSIONS AQUEUSES STABILISEES POUR USAGE PARENTERAL (STABILIZED AQUEOUS SUSPENSIONS FOR PARENTERAL USE)
Czech Republic	303872	Farmaceutický vodný suspenzní prípravek pro parenterální podávání se stabilizovaným pH (Pharmaceutical aqueous suspension formulation for parenteral administration preparation for parenteral administration with stabilized pH value)
Peru	20011322	SUSPENSIONES ACUOSAS ESTABILIZADAS PARA USO PARENTERAL

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

DEPO-SUBQ PROVERA 104 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DEPO-SUBQ PROVERA 104

Introduction

DEPO-SUBQ PROVERA 104, a lower-dose version of the traditional Depo-Provera contraceptive injection, has been designed to be administered subcutaneously, offering several advantages over its predecessor. This article delves into the market dynamics and financial trajectory of DEPO-SUBQ PROVERA 104, including its benefits, challenges, and the ongoing legal and health implications.

Market Positioning

DEPO-SUBQ PROVERA 104 is positioned as a safer and more convenient alternative to the traditional Depo-Provera injection. It contains 104 mg of medroxyprogesterone acetate, compared to the 150 mg dose in Depo-Provera, and is injected into the fatty layer just below the skin. This formulation is intended to provide effective contraception while exposing users to lower levels of synthetic progestin per injection[2].

Advantages and Benefits

Reduced Risk of Adverse Effects

The lower dose of medroxyprogesterone acetate in DEPO-SUBQ PROVERA 104 is associated with a reduced risk of certain adverse effects, such as bone mineral density loss and potentially lower risks of brain tumors like meningioma. This makes it a more appealing option for women concerned about the long-term health impacts of hormonal contraceptives[2][3].

Convenience and Ease of Use

The subcutaneous administration of DEPO-SUBQ PROVERA 104 is more convenient and less invasive than the intramuscular injection of Depo-Provera. This could lead to higher patient compliance and satisfaction, potentially increasing market share in the contraceptive sector[2].

Challenges and Limitations

Market Acceptance and Training

Despite its advantages, the introduction of DEPO-SUBQ PROVERA 104 has faced challenges. The need for additional training for healthcare providers and patients on the subcutaneous administration method could pose logistical hurdles and impact sales. This has likely been a significant consideration for Pfizer, the manufacturer, in terms of resource allocation and market strategy[2].

Revenue Impact

The reduced dosage and more convenient administration of DEPO-SUBQ PROVERA 104 may extend the time between necessary doses, potentially reducing repeat purchases and impacting revenue per patient over time. This financial dynamic could influence Pfizer's marketing and sales strategies, as well as its overall financial projections for the product[2].

Legal and Regulatory Landscape

Ongoing Litigation

DEPO-SUBQ PROVERA 104, along with its predecessor Depo-Provera, is involved in ongoing litigation. Lawsuits allege that the manufacturers knew about potential risks such as brain tumors, cancers, and bone loss but failed to adequately warn users. These legal challenges can significantly impact the financial trajectory of the drug, as they may lead to substantial settlement costs and damage to the product's reputation[2][4].

Regulatory Considerations

Regulatory bodies closely monitor the safety and efficacy of DEPO-SUBQ PROVERA 104. The drug's association with significant loss of bone mineral density, particularly in younger women, is a critical concern that regulators and healthcare providers must address. Ensuring compliance with regulatory requirements and maintaining a favorable safety profile are essential for the drug's continued market presence[3].

Financial Trajectory

Revenue Projections

The financial performance of DEPO-SUBQ PROVERA 104 is influenced by several factors, including market acceptance, competition, and the ongoing legal landscape. While the drug offers several advantages, the potential for reduced repeat purchases due to its lower dosage and more convenient administration could impact revenue projections. Pfizer must balance these factors to maintain profitability and market share[2].

Litigation Costs

The costs associated with ongoing litigation, including potential settlements and awards, can significantly affect the financial trajectory of DEPO-SUBQ PROVERA 104. High-dollar settlements, as anticipated in recent updates, could strain Pfizer's financial resources and impact the drug's overall profitability[4].

Global Access and Distribution

Home-Based Administration

Efforts by organizations like PATH to introduce DEPO-SUBQ PROVERA 104 in the Uniject injection system aim to expand access to this contraceptive method, especially in developing countries. This initiative could enhance the drug's global market reach and contribute to its financial performance by tapping into new markets and user bases[5].

Health Implications and User Experience

Adverse Reactions

Users of DEPO-SUBQ PROVERA 104 may experience various adverse reactions, including weight gain, changes in menstrual bleeding patterns, and injection site reactions. These health implications are crucial for both the user experience and the drug's market dynamics, as they can influence patient compliance and overall satisfaction[1][3].

Bone Mineral Density Loss

The significant loss of bone mineral density associated with DEPO-SUBQ PROVERA 104 is a critical health concern, particularly for younger women. This issue may affect the drug's long-term market viability and necessitate careful monitoring and education for healthcare providers and patients[1][3].

Key Takeaways

• Market Positioning: DEPO-SUBQ PROVERA 104 is positioned as a safer, more convenient alternative to traditional Depo-Provera.
• Advantages: Reduced risk of adverse effects, convenience, and ease of use.
• Challenges: Market acceptance, training needs, and potential revenue impact.
• Legal Landscape: Ongoing litigation related to health risks and regulatory considerations.
• Financial Trajectory: Influenced by market acceptance, competition, litigation costs, and global access initiatives.
• Health Implications: Significant bone mineral density loss and other adverse reactions.

FAQs

Q: What is the main difference between DEPO-SUBQ PROVERA 104 and traditional Depo-Provera?

A: DEPO-SUBQ PROVERA 104 contains a lower dose of medroxyprogesterone acetate (104 mg vs 150 mg) and is administered subcutaneously rather than intramuscularly.

Q: What are the potential health risks associated with DEPO-SUBQ PROVERA 104?

A: The drug is associated with significant loss of bone mineral density, weight gain, changes in menstrual bleeding patterns, and other adverse reactions such as injection site reactions and mood disorders.

Q: Why is there ongoing litigation related to DEPO-SUBQ PROVERA 104?

A: Lawsuits allege that the manufacturers knew about potential risks such as brain tumors, cancers, and bone loss but failed to adequately warn users.

Q: How does the subcutaneous administration of DEPO-SUBQ PROVERA 104 impact its market dynamics?

A: The subcutaneous administration is more convenient but may require additional training for healthcare providers and patients, potentially affecting sales and revenue.

Q: What initiatives are in place to expand global access to DEPO-SUBQ PROVERA 104?

A: Organizations like PATH are working to introduce DEPO-SUBQ PROVERA 104 in the Uniject injection system to expand access, especially in developing countries.

Sources

1. Pfizer Medical Information: DEPO-SUBQ PROVERA 104® (medroxyprogesterone acetate) - US.
2. Lawsuit Information Center: Depo Provera Lawsuit Settlement | December 2024 Update.
3. Pfizer Medical Information: DEPO-SUBQ PROVERA 104® Warnings and Precautions.
4. Robert King Law Firm: Depo-Provera Lawsuit - December 2024 Update.
5. PATH: Home-Based Administration of depo-subQ provera 104™ in the Uniject™ Injection System.