Sirolimus - Generic Drug Details

What are the generic sources for sirolimus and what is the scope of freedom to operate?

Sirolimus is the generic ingredient in four branded drugs marketed by Nobelpharma, Aadi, Pf Prism Cv, Amneal, Apotex, Hetero Labs Ltd V, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in fourteen NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sirolimus has one hundred and fifty-two patent family members in thirty-three countries.

There are twenty-one drug master file entries for sirolimus. Nineteen suppliers are listed for this compound.

Summary for sirolimus

International Patents:	152
US Patents:	7
Tradenames:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	687
Patent Applications:	4,253
Drug Prices:	Drug price trends for sirolimus
What excipients (inactive ingredients) are in sirolimus?	sirolimus excipients list
DailyMed Link:	sirolimus at DailyMed

See drug prices for sirolimus

Recent Clinical Trials for sirolimus

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
Stanford University	Phase 1/Phase 2
Aadi Bioscience, Inc.	Phase 2

See all sirolimus clinical trials

Pharmacology for sirolimus

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

Medical Subject Heading (MeSH) Categories for sirolimus

Anti-Bacterial Agents

Antibiotics, Antineoplastic

Antifungal Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for sirolimus

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AH	Mammalian target of rapamycin (mTOR) kinase inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for SIROLIMUS

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 sirolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	SIROLIMUS	sirolimus	TABLET;ORAL	201676-001	Feb 15, 2023	AB	RX	No	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004		DISCN	Yes	No
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes
Novitium Pharma	SIROLIMUS	sirolimus	SOLUTION;ORAL	211040-001	Jan 28, 2019	AA	RX	No	No
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes

Expired US Patents for sirolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999

EU/EMA Drug Approvals for sirolimus

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 sirolimus

Country	Patent Number	Title	Estimated Expiration
San Marino	T201900751
Russian Federation	2559570	КОМПОЗИЦИИ БЕЗ ПРИОНА НА ОСНОВЕ НАНОЧАСТИЦ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (PRION-FREE COMPOSITIONS BASED ON NANOPARTICLES AND METHODS OF OBTAINING THEREOF)
Lithuania	2419732
Japan	2016011309	抗癌剤としてラパマイシンおよびアルブミンを含むナノ粒子 (NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT)
Lithuania	2131821

Supplementary Protection Certificates for sirolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	24/2001	Austria		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0648494	C00648494/01	Switzerland		PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926
0401747	25/2001	Austria		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0648494	SPC/GB01/037	United Kingdom		PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313

Sirolimus Market Dynamics and Financial Trajectory

Introduction to Sirolimus

Sirolimus, also known as rapamycin, is a medication classified as an immunosuppressant and a mammalian target of rapamycin (mTOR) inhibitor. Originally developed as an antifungal agent, sirolimus is primarily used in transplantation medicine to prevent organ rejection in patients receiving kidney, liver, or heart transplants. It works by inhibiting the activity of the mTOR protein kinase, which plays a crucial role in cell growth and proliferation[1].

Market Size and Growth Projections

The sirolimus market was valued at around USD 270.7 million in 2023 and is anticipated to register a Compound Annual Growth Rate (CAGR) of 3.6% to 4.6% between 2024 and 2032. By 2032, the market is projected to reach USD 370.4 million to USD 424.23 million, depending on the source[1][3][4].

Key Market Drivers

Increasing Prevalence of Organ Transplants

The growing number of organ transplant procedures globally is a significant driver for the sirolimus market. In 2023, the U.S. witnessed a substantial number of organ transplants, including kidney, liver, heart, lung, and other types, which fuels the demand for immunosuppressant medications like sirolimus[1][4].

Advancements in Drug Delivery Systems

Innovations in novel drug delivery systems have significantly improved the therapeutic outcomes and patient experience associated with sirolimus use. These advancements focus on optimizing drug delivery mechanisms to enhance efficacy, increase patient compliance, and minimize adverse effects[1].

Expanding Applications Across Therapeutic Areas

Sirolimus is increasingly being used in various therapeutic areas, including cancer, neurological conditions, cardiovascular conditions, and more. Cancer emerged as the leading therapeutic area in 2023, but neurological conditions are expected to exhibit the highest growth rate during the forecast period[2][3].

Segmentation of the Sirolimus Market

By Application

The market is segmented into organ transplant rejection, lymphangioleiomyomatosis (LAM), and sirolimus-coated balloons and catheter devices. The organ transplant rejection segment held the largest market share in 2023[1].

By Route of Administration

The market is segmented into injection and tablets. Oral administration (tablets) accounted for the highest revenue in 2023, but injectable formulations are expected to witness the highest CAGR during the forecast period due to their targeted drug delivery and enhanced bioavailability[1][2].

By Dosage

The market is segmented into 0.5mg, 1mg, and 2mg. The 1mg segment held a significant market size in 2023, while the 0.5mg dosage dominates due to rising demand[1][4].

By Distribution Channel

The market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. Hospital pharmacies accounted for the largest share in 2023, but online pharmacies are expected to witness significant growth due to the increasing trend of online medication purchases and home delivery services[1][2].

Geographical Analysis

North America and Europe

These regions are the leading revenue contributors to the sirolimus market, driven by the high incidence of cancer and cardiovascular diseases, favorable reimbursement policies, and early adoption of innovative therapeutics[2][3].

Asia Pacific

The Asia Pacific region is expected to witness the highest CAGR during the forecast period, driven by the growing burden of chronic diseases, increasing healthcare expenditure, and expanding access to advanced medical treatments[2][3].

Market Competition

The sirolimus market is competitive, with several large multinationals and small and mid-sized companies. Key players such as Pfizer Inc., Novartis AG, Biocon Limited, and others are focusing on strategic initiatives like product launches, collaborations, acquisitions, and geographic expansions to maintain their competitive edge[2].

Challenges and Pitfalls

Price Volatility in Raw Materials

Fluctuations in the prices of key chemical components can affect production costs, erode profit margins, and impact pricing strategies and market acceptability[5].

Competition from Generic Alternatives

The presence of generic alternatives can further exacerbate pricing pressures, making it challenging to sustain profitability and investment in innovation[5].

Financial Trajectory

The sirolimus market is expected to grow steadily over the forecast period, driven by the increasing prevalence of chronic diseases, advancements in drug delivery systems, and expanding applications across different therapeutic areas. Here are some key financial projections:

• 2023 Market Size: USD 270.7 million to USD 280.13 million[1][4].
• Forecast Period CAGR: 3.6% to 4.6% between 2024 and 2032[1][3][4].
• 2032 Market Size: USD 370.4 million to USD 424.23 million[1][4].

Key Takeaways

• The sirolimus market is driven by the increasing prevalence of organ transplants and advancements in drug delivery systems.
• The market is segmented by application, route of administration, dosage, and distribution channel.
• North America and Europe are key revenue contributors, while Asia Pacific is poised for significant growth.
• Market competition is intense, with top players focusing on strategic initiatives to maintain their market positions.
• Challenges include price volatility in raw materials and competition from generic alternatives.

Frequently Asked Questions (FAQs)

What is the primary use of sirolimus in medical practice?

Sirolimus is primarily used as an immunosuppressant to prevent organ rejection in patients receiving kidney, liver, or heart transplants.

What are the key drivers of the sirolimus market?

The key drivers include the increasing prevalence of organ transplants, advancements in drug delivery systems, and expanding applications across different therapeutic areas.

Which regions are expected to contribute significantly to the sirolimus market growth?

North America and Europe are current leading revenue contributors, while Asia Pacific is expected to witness the highest CAGR during the forecast period.

What are the major challenges facing the sirolimus market?

Major challenges include price volatility in raw materials and competition from generic alternatives.

Who are the key players in the sirolimus market?

Key players include Pfizer Inc., Novartis AG, Biocon Limited, Accord Healthcare, and others.

Cited Sources:

1. GMI Insights: Sirolimus Market Trends 2024-2032, Global Size Analysis.
2. Acute Market Reports: Sirolimus Market Expected to Grow at 4.2% by 2032.
3. Research and Markets: Sirolimus Market Size, Market Share, Application Analysis, Regional ...
4. Data Bridge Market Research: Global Sirolimus Market – Industry Trends and Forecast to 2031.
5. Verified Market Research: Sirolimus API Market Size And Forecast.