RAPAMUNE Drug Patent Profile

When do Rapamune patents expire, and what generic alternatives are available?

Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs.

The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rapamune

A generic version of RAPAMUNE was approved as sirolimus by ZYDUS PHARMS on January 8^th, 2014.

Summary for RAPAMUNE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	233
Patent Applications:	2,713
Drug Prices:	Drug price information for RAPAMUNE
What excipients (inactive ingredients) are in RAPAMUNE?	RAPAMUNE excipients list
DailyMed Link:	RAPAMUNE at DailyMed

See drug prices for RAPAMUNE

Recent Clinical Trials for RAPAMUNE

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

Sponsor	Phase
Stanford University	Phase 1/Phase 2
Markus Mapara	Phase 1/Phase 2
ITB-Med LLC	Phase 1/Phase 2

See all RAPAMUNE clinical trials

Pharmacology for RAPAMUNE

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Paragraph IV (Patent) Challenges for RAPAMUNE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAPAMUNE	Tablets	sirolimus	0.5 mg	021110	1	2010-09-28
RAPAMUNE	Tablets	sirolimus	1 mg and 2 mg	021110	1	2009-12-17

US Patents and Regulatory Information for RAPAMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	AA	RX	Yes	Yes
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000	AB	RX	Yes	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	AB	RX	Yes	Yes
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004		DISCN	Yes	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	AB	RX	Yes	No

Expired US Patents for RAPAMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010

EU/EMA Drug Approvals for RAPAMUNE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Rapamune	sirolimus	EMEA/H/C/000273 Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,	Authorised	no	no	no	2001-03-13
Plusultra pharma GmbH	Hyftor	sirolimus	EMEA/H/C/005896 Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.	Authorised	no	no	yes	2023-05-15

International Patents for RAPAMUNE

See the table below for patents covering RAPAMUNE around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3022880
Israel	111007
Israel	100755	X-ray contrast compositions useful in medical imaging comprising organic iodinated derivatives
Japan	4439590
Singapore	44632	Use of rapamycin for inhibiting transplant in mammals

Supplementary Protection Certificates for RAPAMUNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	01C0037	France		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
0763039	C300348	Netherlands		PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0401747	SPC/GB01/036	United Kingdom		PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0648494	SPC/GB01/037	United Kingdom		PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119

Market Dynamics and Financial Trajectory for RAPAMUNE (Sirolimus)

Market Overview

The global RAPAMUNE (sirolimus) market is experiencing significant growth, driven by its diverse applications and expanding patient base. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Applications of RAPAMUNE

Lymphangioleiomyomatosis (LAM)

RAPAMUNE was approved by the FDA in 2015 as the first treatment for lymphangioleiomyomatosis (LAM), a rare, progressive disease affecting the lungs, kidneys, and lymphatic system. This approval has been a landmark for patients with LAM, providing a treatment option that stabilizes lung function[5].

Organ Transplant Rejection

Sirolimus is widely used to prevent organ transplant rejection. Its immunosuppressive properties make it a crucial drug in post-transplant care, contributing significantly to the market's growth[4].

Sirolimus Coating Balloon and Catheter Devices

The use of sirolimus in coating balloon and catheter devices for cardiovascular procedures is another key application. This segment is growing due to the increasing need for effective treatments in cardiovascular diseases[1].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies are a major distribution channel for RAPAMUNE, given the drug's use in both transplant rejection prevention and treatment of LAM. This channel accounts for a significant portion of the market share[1].

Online Pharmacies

Online pharmacies are becoming increasingly important, especially for patients requiring long-term medication. This channel offers convenience and accessibility, contributing to the market's expansion[1].

Retail Pharmacies

Retail pharmacies also play a crucial role in the distribution of RAPAMUNE, particularly for patients who require ongoing treatment outside of hospital settings[1].

Geographic Market

North America

North America, particularly the United States, holds the largest market share for RAPAMUNE. This is due to the high prevalence of organ transplants, advanced healthcare infrastructure, and increased awareness of rare diseases like LAM[4].

Europe

Europe is the second-largest market, driven by the high number of cancer and organ transplant surgeries. The region's well-developed healthcare system and regulatory environment support the market's growth[4].

Asia Pacific

The Asia Pacific region is expected to see significant growth due to increasing government awareness programs, the availability of generic drugs, and improving healthcare infrastructure. This region is anticipated to account for a substantial market share in the future[2].

Latin America and Rest of the World

Latin America and other regions also contribute to the market, with growing healthcare expenditure and increasing awareness of diseases treatable with sirolimus[1].

Market Size and Growth

The global RAPAMUNE (sirolimus) market has experienced rapid growth in recent years. As of 2023, the market size was valued at several billion USD, and it is anticipated to reach even higher values by 2031, exhibiting a compound annual growth rate (CAGR) of around 5-6% during the forecast period[3][4].

Financial Trajectory

Revenue and Market Share

Key players such as Pfizer, Biocon, Concept Medical, Inc., Dr. Reddy’s Laboratories Ltd., and others are driving the market's financial growth. Pfizer, for instance, reported significant revenue from RAPAMUNE, with the drug contributing to the company's overall financial performance[2][4].

Competitive Landscape

The competitive landscape is characterized by new product launches, expansions, mergers and acquisitions, and strategic partnerships. Companies are focusing on overcoming challenges such as high R&D costs and leveraging opportunities in emerging markets[2].

SWOT Analysis

• Strengths: FDA approvals, diverse applications, and strong market presence.
• Weaknesses: High R&D costs, potential side effects.
• Opportunities: Growing demand in emerging markets, increasing prevalence of target diseases.
• Threats: Competitive market, regulatory challenges[2].

Market Drivers and Restraints

Drivers

• Increasing cases of organ transplant rejection and rare diseases like LAM.
• Advancements in healthcare infrastructure.
• Growing healthcare expenditure.
• Government awareness programs in emerging markets[4].

Restraints

• High cost of R&D.
• Potential side effects and adverse reactions.
• Regulatory hurdles.
• Competition from generic drugs[2].

Technological and Regulatory Trends

FDA Approvals

The FDA approval for RAPAMUNE in treating LAM has been a significant milestone. Such approvals enhance the drug's market credibility and expand its user base[5].

Technological Advancements

The use of sirolimus in coating balloon and catheter devices represents a technological advancement, offering more effective treatment options for cardiovascular diseases[1].

Key Players and Company Profiles

Major players in the RAPAMUNE market include:

• Pfizer, Inc.: Known for its significant contribution to the market, especially with the FDA approval for LAM treatment.
• Biocon: A key player in the biopharmaceutical sector, contributing to the market through its product portfolio.
• Dr. Reddy’s Laboratories Ltd.: Another major player with a strong presence in the generic and pharmaceutical market.
• Concept Medical, Inc.: Focused on innovative medical devices, including those coated with sirolimus[1][2].

Market Attractiveness and Forecast

The market attractiveness matrix indicates a high growth potential in regions like Asia Pacific and Latin America. The forecast suggests sustained growth from 2023 to 2031, driven by increasing demand and expanding applications[2].

Key Takeaways

• The global RAPAMUNE (sirolimus) market is driven by its applications in LAM, organ transplant rejection, and cardiovascular devices.
• North America and Europe are the current leaders, with Asia Pacific expected to grow significantly.
• The market is expected to grow at a CAGR of around 5-6% from 2023 to 2031.
• Key players are focusing on technological advancements and strategic partnerships to maintain market share.
• Regulatory approvals and government awareness programs are crucial drivers of market growth.

FAQs

Q: What are the primary applications of RAPAMUNE (sirolimus)?

A: The primary applications include treatment of lymphangioleiomyomatosis (LAM), prevention of organ transplant rejection, and use in sirolimus coating balloon and catheter devices.

Q: Which region holds the largest market share for RAPAMUNE?

A: North America, particularly the United States, holds the largest market share due to high healthcare expenditure and advanced infrastructure.

Q: What is the expected CAGR for the RAPAMUNE market from 2023 to 2031?

A: The market is expected to grow at a CAGR of around 5-6% during this period.

Q: Who are the major players in the RAPAMUNE market?

A: Major players include Pfizer, Inc., Biocon, Dr. Reddy’s Laboratories Ltd., and Concept Medical, Inc.

Q: What are the key drivers of the RAPAMUNE market?

A: Key drivers include increasing cases of organ transplant rejection and rare diseases, advancements in healthcare infrastructure, and growing healthcare expenditure.

Sources

1. iHealthcareAnalyst: Rapamune (Sirolimus) Market and Forecast 2024-2031.
2. Cognitivemarketresearch: Rapamune Sirolimus Market Report 2024 (Global Edition).
3. Marketresearchintellect: Rapamune (Sirolimus) Market Size, Scope And Forecast Report.
4. Maximizemarketresearch: Sirolimus Market-Industry Analysis and Forecast (2023–2029).
5. Pfizer: Pfizer's RAPAMUNE® (sirolimus) Becomes First FDA-Approved Treatment for Lymphangioleiomyomatosis (LAM), A Rare Progressive Lung Disease.