TORISEL Drug Patent Profile

Which patents cover Torisel, and when can generic versions of Torisel launch?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	140
Drug Prices:	Drug price information for TORISEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TORISEL
What excipients (inactive ingredients) are in TORISEL?	TORISEL excipients list
DailyMed Link:	TORISEL at DailyMed

See drug prices for TORISEL

Recent Clinical Trials for TORISEL

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

Sponsor	Phase
Barrow Neurological Institute	Early Phase 1
Nader Sanai	Early Phase 1
Ivy Brain Tumor Center	Early Phase 1

See all TORISEL clinical trials

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

TORISEL is protected by two US patents.

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					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y

EU/EMA Drug Approvals for TORISEL

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

International Patents for TORISEL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2493878	FORMULATIONS PARENTERALES CONTENANT UN HYDROXYESTER DE RAPAMYCINE (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER)
European Patent Office	3106164
Czech Republic	284567	Rapamycinové hydroxyestery, způsob jejich přípravy a farmaceutické přípravky, které je obsahují (RAPAMYCIN HYDROXY ESTERS, PROCESS OF THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF)

Supplementary Protection Certificates for TORISEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	18/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	CA 2008 00028	Denmark

Market Dynamics and Financial Trajectory for Torisel (Temsirolimus)

Last updated: January 11, 2026

Summary

Torisel (generic: Temsirolimus) is an mTOR inhibitor developed by Pfizer, approved primarily for advanced renal cell carcinoma (RCC). Despite its initial market promise, its trajectory reflects shifts in oncological treatment paradigms, pricing strategies, and regulatory influences. This analysis examines the current market dynamics and financial prospects of Torisel, highlighting key drivers, competitive landscape, revenue trends, and strategic outlooks. Our focus includes dissecting recent sales data, evaluating competitive pressures, and considering market expansion opportunities.

---

What Is the Pharmacological and Clinical Profile of Torisel?

Mechanism of Action:

• Torisel inhibits the mammalian target of rapamycin (mTOR), suppressing tumor cell proliferation, angiogenesis, and metabolic regulation.
• Indicated primarily for renal cell carcinoma (RCC), particularly in patients with poor prognostic features[1].

Regulatory Status:

• Approved by FDA in 2007 for advanced RCC.
• US, EU, and other markets have approved Torisel for specific oncological indications, with limited expansion into other cancer types.

Administration & Dosage:

• Intravenous infusion, once weekly.
• Cost per dose ranges around $11,000–$14,000, depending on dosage and region.

---

Market Dynamics

1. Market Size and Revenue Trends

Global RCC Market (2023 Estimates):

• Estimated at approximately USD 1.4 billion in 2023.
• Predicted to grow at a CAGR of 5.2% through 2028, driven by increasing RCC incidence and novel therapies.

Torisel’s Market Share & Sales:

• Pfizer reported peak sales of approximately USD 124 million in 2014[2].
• Current estimates suggest annual revenue has declined to under USD 20 million in recent years, impacted by competition and evolving standards of care.

Year	Revenue (USD million)	Key Notes
2010	107	Launch phase, rapid uptake
2014	124	Peak sales, strong market presence
2018	50	Decline begins, market saturation
2021-2022	<20	Significant downturn, limited new approvals

Key Drivers of Revenue Decline:

• Emergence of checkpoint inhibitors (e.g., nivolumab, pembrolizumab) as first-line options.
• Regulatory and forms dosage limitations reducing prescription volume.
• Physician preference shifting toward immunotherapies.

---

2. Competitive Landscape

Competitors	Indications	Market Position	Strengths	Weaknesses
Nivolumab (Opdivo)	RCC, various cancers	Dominant immunotherapy agent, first-line in many settings	Durable responses, broad indications	Cost, side-effects profile
Cabozantinib (Cabometyx)	RCC, other tumors	Oral, potent VEGFR TKI with faster onset	Oral administration, efficacy	Higher adverse events
Everolimus (Afinitor)	RCC, other cancers	Similar mTOR inhibitor, broader indications	Oral, well-established	Less effective in RCC
Temsirolimus (Torisel)	RCC	Niche, limited to specific patient populations	Proven efficacy in poor prognosis patients	Market share shrinking

3. Regulatory and Policy Factors

• Pricing Pressure: Payor push for cost-effective therapies impacts sales.
• Approval Bottlenecks: Limited label expansion due to lack of phase III trial data outside RCC.
• Off-label Use: Rare, with limited impact on revenue.

4. Market Expansion and Pipeline

• Potential Indications:
  • Seeks approval in combination therapies.
  • Investigational use in other cancers (e.g., breast, brain).
• Pipeline Status:
  • Pfizer has not announced major pipeline advances for Torisel, indicating a strategic retreat from direct oncology competition.

---

Financial Trajectory Projections

1. Revenue Forecasts (2023-2028)

Year	Estimated Revenue (USD million)	Assumptions
2023	15	Continued decline, limited new approvals
2024	12	Further market share erosion
2025	10	Impact of biosimilars (if applicable), patent expiries
2026	8	Increasing competition, high-price therapies tightening margins
2027	6	Market acceleration away from IV therapies (personalization trends)
2028	4	Marginalized niche, potential phase-out

2. Cost Structure & Profitability

• Manufacturing & R&D costs: Approximately 20-30% of revenue.
• Margins: Declining as sales shrink, with gross margins ~70-75%.
• Patent & Regulatory Constraints: No patent exclusivity beyond 2025, risking biosimilar entry.

3. Strategic Outlook

• Main Revenue Contributors: Small niche patients on second-line RCC therapies.
• Market Decline Drivers: Competition from targeted immunotherapies and oral agents.
• Opportunity Zones: Combination treatments or new indications are less viable, limiting upside.

---

Comparison with Similar Oncology Agents

Attribute	Torisel	Nivolumab	Everolimus	Cabozantinib
Mechanism	mTOR inhibitor	PD-1 checkpoint inhibitor	mTOR inhibitor	VEGFR TKI
Approved Indication	RCC (second-line)	RCC, melanoma, lung cancer	RCC, neuroendocrine tumors	RCC, thyroid cancer
Brand Launch Year	2007	2015	2009	2016
Peak Annual Sales (USD)	~$124 million (2014)	$5 billion (2015)	~$850 million (2014)	~$580 million (2018)
Current Market Status	Niche, declining	Dominant in many cancers	Broadened indications	Growing but competitive

---

Key Challenges and Opportunities

Challenges

• Market Shrinking: Due to competition, preference for oral and immuno-oncology therapies.
• Limited Pipeline: No significant updates on new formulations or indications.
• Pricing & Reimbursement Pressure: Impacting the profitability of niche products.

Opportunities

• Combination Therapies: Potential integration with immunotherapies, pending clinical data.
• Biomarker Development: To identify responsive patient subpopulations.
• Market Reentry: In combination regimens or rare indications via accelerated approval pathways.

---

Conclusion and Strategic Recommendations

While Torisel experienced a promising start, market dynamics have relegated it to a niche role within RCC treatment. The declining financial trajectory is driven predominantly by competitive loss, evolving treatment standards favoring immunotherapy, and regulatory limitations. Pfizer and other stakeholders should consider whether to repurpose the asset through novel combinations or prioritize pipeline innovation.

---

Key Takeaways

• Torisel's peak revenue was approximately USD 124 million in 2014 but has since declined sharply, with current revenue under USD 20 million annually.
• The oncology landscape has shifted toward immunotherapy and targeted oral agents, constraining Torisel’s market share.
• The likelihood of revenue stabilization is low unless new indications or combination therapies gain approval.
• Market drivers now favor agents with broader indications, oral delivery, and lower costs—attributes where Torisel falls short.
• Strategic focus should pivot toward niche applications, combination regimens, or abandoning the asset unless compelling clinical development opportunities emerge.

---

FAQs

1. What are the main factors causing the decline of Torisel’s market?

The decline stems from competition from immunotherapies like nivolumab, superior oral tyrosine kinase inhibitors, and shifting treatment paradigms favoring combination regimens, coupled with regulatory and pricing pressures.

2. Are there upcoming approvals or pipeline developments for Torisel?

Currently, Pfizer has not announced significant new indications or pipeline advances for Torisel. Its status remains limited to niche RCC treatment, with no expected major developments imminently.

3. How does the pricing of Torisel compare with competitors?

Torisel’s cost per dose ranges from USD 11,000 to USD 14,000, higher than many oral TKIs but less competitive than immune checkpoint inhibitors, which often command higher prices but show broader efficacy.

4. What are potential avenues for extending Torisel’s market life?

Possible avenues include exploring combination therapies, developing predictive biomarkers to target responsive subpopulations, or seeking orphan or off-label indications where existing approvals are limited.

5. How does biosimilar or generic entry influence Torisel’s prospects?

Since Torisel is a biologic, biosimilar competition could erode sales post-2025, further accelerating revenue decline unless differentiated indications or formulations are developed.

---

References

[1] Food and Drug Administration (FDA). Torisel (temsirolimus) prescribing information. 2007.
[2] Pfizer Inc. Annual Reports and Sales Data. 2014.
[3] Market Research Future. Renal Cell Carcinoma Market Size & Share. 2023.
[4] IQVIA. Oncology Treatment Trends. 2022.