TEMSIROLIMUS Drug Patent Profile

Which patents cover Temsirolimus, and what generic alternatives are available?

Temsirolimus is a drug marketed by Accord Hlthcare and Gland and is included in two NDAs.

The generic ingredient in TEMSIROLIMUS is temsirolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Temsirolimus

A generic version of TEMSIROLIMUS was approved as temsirolimus by ACCORD HLTHCARE on July 30^th, 2018.

Summary for TEMSIROLIMUS

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	223
Patent Applications:	4,406
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEMSIROLIMUS
DailyMed Link:	TEMSIROLIMUS at DailyMed

Recent Clinical Trials for TEMSIROLIMUS

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

Sponsor	Phase
Rapa Therapeutics LLC	PHASE2
Barrow Neurological Institute	Early Phase 1
Nader Sanai	Early Phase 1

See all TEMSIROLIMUS clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TEMSIROLIMUS

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

Paragraph IV (Patent) Challenges for TEMSIROLIMUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TORISEL	Injection	temsirolimus	25 mg/mL, 1.8 mL vial	022088	1	2011-05-25

US Patents and Regulatory Information for TEMSIROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	TEMSIROLIMUS	temsirolimus	SOLUTION;INTRAVENOUS	203153-001	Jul 30, 2018	AP	RX	No	No
Gland	TEMSIROLIMUS	temsirolimus	SOLUTION;INTRAVENOUS	207383-001	Aug 16, 2019	AP	RX	No	No

EU/EMA Drug Approvals for TEMSIROLIMUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Torisel	temsirolimus	EMEA/H/C/000799Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).	Authorised	no	no	no	2007-11-19

Market Dynamics and Financial Trajectory for Temsirolimus

Last updated: February 19, 2026

What is the current market landscape for temsirolimus?

Temsirolimus, marketed under the brand name Torisel, is an mTOR inhibitor approved primarily for treating advanced renal cell carcinoma (RCC). Developed by Pfizer, it received FDA approval in 2007. It targets the mechanistic target of rapamycin (mTOR) pathway, which influences cell growth and proliferation.

The drug's market is characterized by limited indications, primarily RCC and certain other cancers. Its patent expired in Europe in 2021, with generics entering the market. Patent expiry impacts revenue streams, introducing price competition.

As of 2023, the global RCC treatment market exceeds $7 billion, with mTOR inhibitors accounting for roughly $1 billion. Temsirolimus ranks among the key therapies but faces competition from second-generation mTOR inhibitors and immune checkpoint inhibitors.

How does regulatory status influence the market?

Regulatory approvals dictate access and reimbursement. Temsirolimus is approved in over 50 countries. Its approval for refractory or untreated RCC has remained stable; however, new indications have not been added since 2010.

Recent regulatory focus involves biosimilars and generics following patent expiry, which reduces market exclusivity. In 2021, Pfizer's patent expiration led to generic versions in Europe; similar transitions are probable in the US, subject to patent litigation and market acceptance.

What are the factors impacting sales and adoption?

Primarily driven by:

• Market competition: Immunotherapies like nivolumab and cabozantinib increasingly replace mTOR inhibitors in RCC treatment, reducing demand for temsirolimus.
• Efficacy and safety profile: Temsirolimus offers moderate survival benefits with manageable toxicity. Segment-specific approaches, like combination therapies, influence its use.
• Reimbursement policies: Varying across countries, heavily impacting sales volumes.
• Pipeline developments: No robust phase III trials for temsirolimus in new indications, limiting expansion potential.

What is the financial trajectory outlook?

Historical revenue data indicate:

Year	Global Sales (USD millions)	Notes
2015	150	Peak of patent protection
2018	100	Influence of rising competition
2020	70	Impact of biosimilar entries in Europe
2022	50	Continued decline, limited new indications

Projected revenues suggest a continued decline with a compound annual growth rate (CAGR) of approximately -12% through 2027, assuming current competition and patent landscape.

Emerging trends point toward:

• Further erosion of sales in mature markets.
• Potential stabilizations in emerging markets with limited competition.
• Increase in biosimilar and generic availability may exert additional pressure.

How might future developments influence market and financial outlooks?

• New combination therapies: Lack of significant ongoing trials for temsirolimus suggests limited future revenue growth.
• Pipeline activity: Absence of pipeline expansion constrains market share recovery.
• Regulatory changes: Stricter reimbursement controls could further limit sales.
• Pricing pressure: Cost-containment measures in healthcare could reduce therapeutic pricing.

What strategic considerations should stakeholders prioritize?

• Transition to combination regimens integrating temsirolimus might extend revenue lifespan.
• Monitoring biosimilar patent disputes can inform market entry strategies.
• Opportunities exist in niche markets where alternatives are unavailable.
• R&D investments might target new indications, although no current data supports imminent launches.

Key Takeaways

• Temsirolimus faces significant revenue decline due to patent expiry and competition.
• The evolving RCC treatment landscape favors immune checkpoint inhibitors over mTOR inhibitors.
• Market stability relies on geographic expansion and potential new indications.
• Generic and biosimilar penetration intensifies pricing pressures.
• Future prospects are limited without pipeline expansion or combination strategies.

FAQs

1. What are the primary competitors to temsirolimus?
   Drugs like nivolumab, cabozantinib, and everolimus are key competitors in RCC treatment.

2. Will temsirolimus regain market share?
   Unlikely without new indications or combination therapies, given current competition and patent expirations.

3. Are biosimilars available for temsirolimus?
   Biosimilars are not yet approved but are anticipated following patent expiration.

4. Can temsirolimus be repurposed for other indications?
   Clinical trials for other cancers are limited; current focus remains on RCC.

5. What market opportunities remain for temsirolimus?
   Niche markets with unmet medical needs and regions with limited access to newer therapies.

---

References

[1] GlobalData. (2023). Renal Cell Carcinoma Treatment Market Report.
[2] FDA. (2007). FDA Approval Document for Temsirolimus.
[3] Pfizer. (2022). Annual Report.
[4] IQVIA. (2023). Oncology Market Data.
[5] European Medicines Agency. (2021). Patent and Biosimilar Data.