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CAMCEVI KIT Drug Patent Profile

Which patents cover Camcevi Kit, and what generic alternatives are available?

Camcevi Kit is a drug marketed by Accord and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-seven patent family members in eighteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Camcevi Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 16, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAMCEVI KIT

International Patents:	37
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	CAMCEVI KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CAMCEVI KIT

Constraining patent/regulatory exclusivity:

10,646,572

NDA:

211488

Dosage:

EMULSION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CAMCEVI KIT

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

US Patents and Regulatory Information for CAMCEVI KIT

CAMCEVI KIT is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,646,572.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes	10,646,572		Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes	9,572,857		Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes	11,717,555		Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes	9,744,207		Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes

International Patents for CAMCEVI KIT

When does loss-of-exclusivity occur for CAMCEVI KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAMCEVI KIT around the world.

Country	Patent Number	Title	Estimated Expiration
China	101400363
New Zealand	766167	Pharmaceutical compositions having a selected release duration
Japan	5242415
European Patent Office	1984009	COMPOSITIONS PHARMACEUTIQUES A STABILITE AMELIOREE (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY)
Israel	275448	תכשירים רוקחיים עם משך שחרור נבחר (Pharmaceutical compositions having a selected release duration)
Australia	2007207618	Pharmaceutical compositions with enhanced stability

CAMCEVI KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CAMCEVI Kit

Introduction

CAMCEVI, a novel formulation of leuprolide mesylate, has recently entered the U.S. market, marking a significant advancement in the treatment of advanced prostate cancer. This article delves into the market dynamics and financial trajectory of CAMCEVI, highlighting its launch, technological innovations, market reception, and the financial implications for its manufacturers and partners.

Technological Innovation

CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection, coming in a pre-filled syringe with no mixing required. This innovation is based on Foresee Pharmaceuticals' pioneering Stabilized Injectable Formulation (SIF) technology, which simplifies the preparation and administration process for healthcare professionals[1][4].

Market Launch and Partnerships

The U.S. launch of CAMCEVI was facilitated through a partnership between Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., and Foresee Pharmaceuticals. Accord BioPharma is responsible for the commercialization of CAMCEVI in the U.S., while Foresee Pharmaceuticals developed the drug and obtained FDA approval on May 25, 2021[1][4].

Clinical Efficacy and Safety

CAMCEVI has demonstrated consistent testosterone suppression to castrate levels in clinical trials. An open-label, single-arm study involving 137 adults showed effective testosterone suppression from Week 4 to Week 48 after the initial injection. Common adverse reactions include hot flush, hypertension, injection site reactions, and musculoskeletal pain[1][4].

Market Reception

The introduction of CAMCEVI has been well-received by the medical community due to its convenience and effectiveness. The pre-filled syringe format eliminates the need for mixing, making it easier for healthcare professionals to administer the treatment. This convenience is expected to enhance patient compliance and improve the overall treatment experience[1][4].

Financial Trajectory

Revenue Potential

The launch of CAMCEVI is part of Accord BioPharma's strategy to expand its specialty pharmaceutical portfolio. Given the growing demand for novel drug delivery systems, CAMCEVI is poised to capture a significant share of the market. The global novel drug delivery systems market is projected to grow at a CAGR of 22.10% between 2023 and 2030, reaching USD 49.0 billion by 2030[3].

Commercialization Support

Accord BioPharma has partnered with EVERSANA to support the commercialization of CAMCEVI. EVERSANA provides field deployment solutions, training, and a comprehensive data and analytics platform, which are crucial for the successful launch and ongoing support of the drug[4].

Patient Assistance Programs

To enhance market penetration, Accord BioPharma offers various patient assistance programs, including commercial copay assistance solutions and a nurse-staffed clinical hotline. These programs help in increasing patient access and adherence to the treatment[4].

Financial Performance of Accord BioPharma

While specific financial data for CAMCEVI is not yet fully disclosed, the overall financial performance of Accord BioPharma and its parent company, Intas Pharmaceuticals, provides context. Intas Pharmaceuticals has a strong track record of growth, both organically and through acquisitions, expanding its product portfolio and operations globally[4].

Industry Trends and Drivers

The novel drug delivery systems market is driven by several factors, including increased COVID-19 vaccination rates, new product introductions, and the rise in chronic diseases. The targeted drug delivery systems segment, which includes CAMCEVI, is expected to post the highest CAGR during the forecast period[3].

Challenges and Restraints

Despite the positive outlook, the market faces challenges such as the growing use of generic medications and regulatory hurdles. However, strategic partnerships and the introduction of new products, like CAMCEVI, offer significant opportunities for growth and market expansion[3].

Key Takeaways

• Innovative Technology: CAMCEVI's ready-to-inject formulation simplifies treatment administration.
• Strong Partnerships: Collaboration between Accord BioPharma and Foresee Pharmaceuticals, along with support from EVERSANA, enhances commercialization efforts.
• Clinical Efficacy: Consistent testosterone suppression and a favorable safety profile.
• Market Growth: Part of a growing novel drug delivery systems market expected to reach USD 49.0 billion by 2030.
• Patient Support: Various patient assistance programs to increase access and adherence.

FAQs

Q: What is CAMCEVI and how is it administered? A: CAMCEVI is a ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection, coming in a pre-filled syringe with no mixing required.

Q: Who are the key partners involved in the launch of CAMCEVI? A: Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., and Foresee Pharmaceuticals are the primary partners. EVERSANA also supports the commercialization efforts.

Q: What are the common adverse reactions associated with CAMCEVI? A: Common adverse reactions include hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

Q: How does CAMCEVI fit into the broader market of novel drug delivery systems? A: CAMCEVI is part of the growing novel drug delivery systems market, which is expected to reach USD 49.0 billion by 2030, driven by factors such as new product introductions and the rise in chronic diseases.

Q: What support programs are available for patients using CAMCEVI? A: Accord BioPharma offers commercial copay assistance solutions, patient assistance programs, and a nurse-staffed clinical hotline to support patients.

Sources

1. Accord BioPharma, in Partnership with Foresee Pharmaceuticals, Launches CAMCEVI (Leuprolide) 42mg Injection Emulsion in the U.S. for the Treatment of Advanced Prostate Cancer in Adults. PR Newswire.
2. Blueprint Medicines Reports Fourth Quarter and Full Year 2022. Blueprint Medicines.
3. Novel Drug Delivery Systems (NDDS) Market By Share, Size and Forecast 2023-2030. Credence Research.
4. EVERSANA and Accord BioPharma Support Launch of CAMCEVI. Access Market Intelligence.