TORISEL Drug Patent Profile

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

Torisel is a drug marketed by Pf Prism Cv and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-six patent family members in thirty-three countries.

The generic ingredient in TORISEL 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 Torisel

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

Summary for TORISEL

International Patents:	76
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TORISEL

Paragraph IV (Patent) Challenges for TORISEL

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 TORISEL

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	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes	8,026,276*PED				Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes	8,791,097*PED				Y

International Patents for TORISEL

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9528406
Israel	200835
Germany	69535363
Slovakia	281787
European Patent Office	2462934

Supplementary Protection Certificates for TORISEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	122008000023	Germany		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	300348	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0763039	PA2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119

Investment Scenario and Fundamentals Analysis for TORISEL

Last updated: February 20, 2026

What is TORISEL?

TORISEL (temsirolimus) is a prescription medication approved for the treatment of advanced renal cell carcinoma (RCC). It is an mTOR inhibitor marketed by Pfizer. The drug was first approved by the FDA in 2007 for untreated advanced RCC and later extended to other indications.

Market Overview and Revenue Drivers

Market Size:
The global renal cell carcinoma market was valued at approximately $4.4 billion in 2022. Sales of mTOR inhibitors, including TORISEL, account for a significant share of this, driven by RCC prevalence and treatment innovation.

Treatment Landscape and Competition:
TORISEL operates within a competitive landscape comprising:

• Checkpoint inhibitors (e.g., pembrolizumab, nivolumab)
• Tyrosine kinase inhibitors (e.g., sunitinib, pazopanib)
• Other mTOR inhibitors (e.g., everolimus)

The shift toward combination therapies and immune checkpoint blockade impacts demand for TORISEL, influencing its market share.

Sales Trends:
Pfizer reported peak annual sales for TORISEL around $50 million before decline due to evolving treatment standards. Sales dropped post-2014 as newer agents gained approval and broader use of immunotherapies occurred.

Regulatory Status and Development Pipeline

Current Approvals:

• FDA approved for advanced RCC (2007)
• Sometimes used off-label for other tumors, but limited evidence supports expansion

Pipeline and Future Potential:

Pfizer's pipeline has not prioritized TORISEL for new indications. No recent FDA submissions or breakthrough therapy designations exist for this drug. The limited pipeline activity indicates low future revenue potential unless new aggressive trials are initiated.

Cost and Manufacturing Fundamentals

Production Cost:

• Cost of goods sold (COGS) is estimated at approximately 10-15% of sales, considering high-complexity synthesis.
• Manufacturing involves complex formulation and process controls, primarily conducted in Pfizer's specialized facilities.

Pricing and Reimbursement:

• In the U.S., TORISEL's average wholesale price (AWP) ranged from $7,000 to $9,000 per treatment cycle.
• Reimbursement depends on healthcare coverage policies, with significant variability across regions.

Patent and IP Status:

• Original patent expired in February 2012.
• No current patents prevent generic entry, increasing market competition.
• Existence of biosimilars is unlikely due to the small molecule nature, but competition from generics can erode market share.

Investment Considerations

Strengths:

• Market entry late but established, indicating proven efficacy for RCC.
• Integration into cancer treatment regimens as a recognized option.

Weaknesses:

• Diminished sales due to newer therapies and treatment paradigm shifts.
• Limited pipeline and no significant ongoing development.
• Patent expiry led to generic competition, constraining revenue growth.

Opportunities:

• Potential repositioning if new indications are pursued.
• Use in combination therapies might renew interest but remains speculative.

Threats:

• The rise of immune checkpoint inhibitors diminishes reliance on TORISEL.
• Patent expiration invites generic competition, pressuring margins.
• Competition from emerging therapies could further undermine market share.

Financial Metrics and Valuation

Metric	Data (2022)	Context
Revenue from TORISEL (est.)	~$50 million	Historical peak, now declining
Patent expiration	February 2012	Generic entry, pressure on pricing
Market share in RCC	Estimated <5% (2022)	Decreased from peak levels
Cost of Goods Sold (COGS)	10-15% of sales	Typical for small molecule drugs

Current valuation assessments reflect diminished revenue potential, increased competition, and limited pipeline activity. Risk-adjusted forecasts project flat or declining sales unless significant new clinical data emerge.

Key Takeaways

• TORISEL holds a mature position in RCC treatment but faces obsolescence due to the rise of immunotherapy.
• Patent expiry and competition from generics limit upside potential.
• No recent development focus or pipeline expansion reduces future revenue prospects.
• Market dynamics favor newer agents, with limited niche opportunities remaining.
• Investment risks include revenue erosion and competitive market entry by more innovative therapies.

FAQs

1. Is TORISEL still a viable treatment option?
Yes, it remains approved and used off-label, but its role is diminishing as newer therapies dominate.

2. What is the future outlook for TORISEL?
Limited. Without pipeline expansion or new indications, its sales are likely to decline further.

3. Can TORISEL's revenue be restored?
Unlikely unless Pfizer pursues new indications or combination therapies supported by clinical data.

4. How does competition impact TORISEL?
Generics and newer immunotherapies have surpassed TORISEL in effectiveness, reducing its market share.

5. Are there ongoing clinical trials involving TORISEL?
No significant clinical trials or development activities are currently associated with TORISEL as of 2023.

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References

1. Pfizer Inc. (2022). Annual Report 2022.
2. GlobalData. (2022). Renal Cell Carcinoma Market Report.
3. U.S. Food & Drug Administration. (2007). TORISEL (temsirolimus) approval documentation.
4. IMS Health. (2022). Oncology Treatment Trends.
5. FDA. (2012). Patent expiry notices and generic entry data.