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
Patent Applications:	4,406
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
Nader Sanai	Early Phase 1
Ivy Brain Tumor Center	Early Phase 1
Barrow Neurological Institute	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	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

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
Austria	234307
Austria	350384
Austria	537176
Australia	2247495

Supplementary Protection Certificates for TORISEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	CA 2008 00028	Denmark
0763039	91438	Luxembourg		91438, EXPIRES: 20200414
0763039	PA2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039	300348	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY

Last updated: June 13, 2026

Torisel (temsirolimus) market dynamics and financial trajectory: sales trends, exclusivity, competition, and revenue exposure

Executive summary: Torisel (temsirolimus) generated meaningful branded oncology revenue in the early-to-mid 2010s, then faced step-down pressure from loss of exclusivity windows, channel normalization, and shifting treatment paradigms in renal cell carcinoma. The core market dynamics are driven by (1) how temsirolimus positions within first-line and intermediate/poor-risk advanced RCC treatment algorithms, (2) the timing of patent/exclusivity expiries and the ability of generics or alternatives to enter, and (3) pricing, payer coverage, and substitution risk across major geographies. Its financial trajectory is best read as a “branded peak then erosion” curve typical for oncology products whose distinctiveness narrows as newer regimens expand and as patent-protected product lifecycle events unfold.

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What market dynamics drive Torisel (temsirolimus) sales growth and decline in renal cell carcinoma?

Torisel’s commercial performance tracks renal cell carcinoma (RCC) practice patterns more than marginal competitive gains. The drug’s key market drivers are:

• Risk-stratified prescribing in advanced RCC: Torisel is most relevant where clinicians use risk categories and where temsirolimus fits alongside or after other standards of care.
• Treatment-line migration: As combination regimens and newer targeted therapies proliferate, temsirolimus tends to lose share when sequencing shifts toward drugs with broader label coverage or more favorable outcomes in common care pathways.
• Payer coverage and step edits: Oncology reimbursement often tightens over time via prior authorization, coverage thresholds, and formulary tiering. Once payer pressure increases, branded share erodes even without immediate generic entry.
• Channel and hospital acquisition economics: For IV oncology drugs, distribution contracts and hospital purchasing behavior can materially affect realized net sales, especially after manufacturer list price resets and contract renegotiations.

Commercial consequence: In branded oncology, revenue decline often accelerates when either (a) exclusivity ends and substitution risk rises or (b) payer formularies change regardless of exclusivity.

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How has Torisel’s financial trajectory evolved over time versus its branded oncology peer set?

A typical trajectory for an IV specialty oncology brand like Torisel shows:

1. Early growth or stabilization following launch and label uptake.
2. Peak revenue as evidence and guideline adoption increase.
3. Gradual erosion tied to clinical preference drift and payer pressure.
4. Steeper step-down around exclusivity and competitive entry events (even if generics do not instantly capture volume, the pricing floor changes and negotiation pressure increases).

Peer comparison lens (RCC oncology): Brands that remain embedded in narrowly-defined risk populations tend to show smoother declines. Products tied to more broadly eligible patient populations show slower erosion until late lifecycle.

Practical read-through for finance teams:

• If Torisel’s usage is mostly concentrated in specific RCC subgroups, volume decay can precede formal generic entry due to guideline switching.
• Net sales erosion can be driven more by contracting and rebates than by unit declines alone.

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When do Torisel exclusivity and patent timelines influence generic or biosimilar competition risk?

Torisel is small-molecule temsirolimus, so it faces generic (ANDA) rather than biosimilar pathways. The exclusivity and patent timeline affects:

• Paragraph IV Orange Book certifications and potential early generic approvals
• Commercially meaningful substitution after FDA approval and launch
• Manufacturer settlement leverage during litigation or threat periods

Featured-snippet answer: Torisel’s competitive risk rises in windows tied to Orange Book patent expiries and any non-patent exclusivity that delay ANDA approvals.

What matters for revenue exposure:

• The closer the remaining exclusivity is to expiration, the greater the probability that payers and wholesalers pressure for price concessions.
• Even before generic launch, the market often anticipates loss of exclusivity through contract renegotiations.

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What is the Orange Book status of Torisel, and how many patents cover temsirolimus in the US?

Torisel’s US patent landscape is determined by FDA Orange Book listings for temsirolimus products under the NDC(s) held by the brand. A complete count of patents and their expiration dates is required to quantify generic entry timing, litigation probability, and settlement value. Without a complete Orange Book listing set with NDC-level granularity, the patent count and expiry mapping cannot be stated precisely.

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What patents protect Torisel formulations, methods of use, and dosing regimens?

Torisel’s protection typically falls into several buckets:

• Composition of matter for temsirolimus (primary long-horizon protection if applicable)
• Formulation patents (stabilizers, solvent systems, concentration, lyophilized vs. liquid presentation, packaging-related protections)
• Methods of use for RCC risk categories, treatment lines, or combination regimens

Commercial relevance: If composition-of-matter protection ends first while formulation or method patents remain, generic entry can be delayed or constrained to narrow carve-outs that reduce immediate substitution impact.

Featured-snippet answer: The strongest revenue-protecting layer is usually composition of matter, while formulation and method patents can extend market exclusivity in practice.

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Which companies are challenging Torisel with ANDA Paragraph IV filings, and what litigation outcomes matter?

ANDA Paragraph IV filings typically indicate:

• A generic company asserts that listed patents are invalid, unenforceable, or would not be infringed.
• The brand may sue to trigger the 30-month stay and potentially a settlement.

Revenue impact chain:

1. ANDA filing creates market expectation of future competition.
2. Litigation and settlement define launch timing.
3. Court or settlement terms define whether launch is immediate on approval or delayed.

Featured-snippet answer: For Torisel, competitive entry risk is governed by Orange Book-tied patent challenges and subsequent settlement or court outcomes, which determine launch dates and whether launch occurs “at-risk.”

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How does Torisel compare with alternative RCC therapies on competitive share dynamics?

Torisel competes in the same treatment ecosystem as:

• VEGF-targeting agents
• Immune checkpoint inhibitor-based regimens
• mTOR inhibitors and other mechanism alternatives
• Combination and sequencing strategies that affect prescribing behavior

Key comparison for market dynamics:

• Mechanism overlap can force substitution even if clinical nuance differs.
• When newer regimens expand in label scope and evidence breadth, payer policies may favor them.

Featured-snippet answer: Torisel’s competitive threat grows as clinicians and payers shift toward regimens that cover a larger portion of the RCC patient pool or show improved outcomes in practice-relevant endpoints.

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What generic entry risks exist for Torisel, and what barriers can slow substitution?

Generic entry risks depend on:

• Remaining enforceable Orange Book patents
• Whether generics can demonstrate bioequivalence and manufacturing suitability for IV products
• Formulation and method-of-use constraints that create “design-around” or carve-out launches
• Payer and provider willingness to switch, which can be influenced by supply reliability and contract terms

Barriers that slow substitution:

• Formulation-specific barriers
• Method-of-use patent fences
• Ongoing brand pricing and contracting moves pre-launch

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What regulatory events (FDA approvals, label expansions, recalls) influenced Torisel’s sales trajectory?

Torisel’s financial trajectory is sensitive to:

• Label scope changes (expanded or narrowed indications)
• Safety updates that affect prescribing comfort
• Packaging or administration changes that affect uptake
• Formulation availability events that can change short-term supply

Without a specific FDA event timeline mapped to Torisel’s label over time, precise regulatory-cause attribution to sales movements cannot be made in a data-backed way.

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How do pricing, rebates, and payer contracting affect Torisel net sales even without generic entry?

In specialty oncology:

• List price does not predict realized revenue. Net sales are shaped by:
  • Manufacturer rebates
  • Hospital purchasing agreements
  • GPO contracts
  • Payer formulary position and step edits
  • Patient assistance program economics

Commercial read-through:

• Even if unit volumes remain stable, net sales can fall due to contract renegotiations once exclusivity weakens or competitive alternatives gain traction.
• Any period where payers expect upcoming generic entry tends to correlate with increased pressure on brand pricing.

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Revenue exposure mapping: where does Torisel face the highest downside risk?

Torisel’s downside concentrates in geographies and accounts where:

• Treatment guidelines already favor comparator regimens over temsirolimus in common RCC populations
• Hospital systems use centralized purchasing
• Payer formularies tighten and require step therapy
• Contracting vehicles anticipate generic substitution

Featured-snippet answer: The highest downside risk is typically in large US hospital networks and payer segments where contracting is most aggressive and switching is operationally easiest.

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Key Takeaways

• Torisel’s market dynamics are primarily driven by RCC treatment-line and risk-stratified prescribing, payer contracting, and guideline shifts rather than by day-to-day competitive marketing alone.
• The financial trajectory for a branded IV specialty oncology product typically follows a peak-then-erosion pattern, with steeper steps around patent/exclusivity milestones.
• Generic entry risk is governed by Orange Book patent expirations tied to temsirolimus and any Paragraph IV litigation outcomes that define launch timing and carve-outs.
• Even before generic approval, net sales often erode via rebate and contract pressure as exclusivity weakens and prescriber preference migrates to alternative RCC regimens.

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FAQs

1. How does temsirolimus lose share when RCC treatment shifts to immuno-oncology combinations?
2. What factors determine whether a generic can launch for temsirolimus soon after ANDA approval?
3. How do method-of-use patents impact generic substitution for small-molecule oncology drugs like Torisel?
4. What payer formulary strategies most strongly influence net sales for IV oncology brands during late lifecycle?
5. How do hospital purchasing and GPO contracting change realized revenue trajectories for specialty oncology drugs?

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drugs@FDA: Torisel (temsirolimus). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/