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 five 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	140
Patent Applications:	3,938
Drug Prices:	Drug price information 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

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

Expired US Patents for TORISEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007

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/000799 Renal-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
Germany	69529897
Japan	2015083595	乳頭状腎細胞癌におけるテムシロリムス（Ｔｅｍｓｉｒｏｌｉｍｕｓ）の抗腫瘍活性 (ANTI-TUMOR ACTIVITY OF TEMSIROLIMUS IN PAPILLARY RENAL CELL CARCINOMA)
Russian Federation	2344821	ПАРЕНТЕРАЛЬНЫЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГИДРОКСИЭФИРЫ РАПАМИЦИНА (RAPAMYCINE HYDROXY ETHERS-CONTAINING PARENTERAL COMPOSITIONS)
Germany	60319118
Canada	2493878	FORMULATIONS PARENTERALES CONTENANT UN HYDROXYESTER DE RAPAMYCINE (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER)
Denmark	2462934

Supplementary Protection Certificates for TORISEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	300348	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	CA 2008 00028	Denmark
0763039	08C0018	France		PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	C00763039/01	Switzerland		FORMER OWNER: WYETH, US
0763039	18/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119

TORISEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: TORISEL

Introduction

TORISEL, also known as temsirolimus, is a significant drug in the treatment of advanced renal cell carcinoma (RCC) and mantle cell lymphoma. Developed by Pfizer, it is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for these indications. Here, we will delve into the market dynamics and financial trajectory of TORISEL.

Mechanism of Action and Clinical Use

TORISEL works by inhibiting the mTOR protein, which is crucial for cell division, growth, and survival. This inhibition reduces the levels of certain growth factors, such as vascular endothelial growth factor (VEGF), which are essential for tumor growth and angiogenesis[1][3].

Approval and Indications

TORISEL is approved in the U.S. and European Union for the treatment of advanced RCC, particularly in patients with poor prognostic risk profiles. It is also approved for the treatment of mantle cell lymphoma in patients whose disease has relapsed or is refractory to other treatments[1][3].

Clinical Efficacy

In advanced RCC, TORISEL has demonstrated significant efficacy. A pivotal Phase 3 trial showed that patients treated with TORISEL alone survived for 10.9 months on average, compared to 7.3 months for those treated with interferon alfa alone. For mantle cell lymphoma, TORISEL prolonged the time patients lived without their disease worsening to 4.8 months, compared to 1.9 months with alternative treatments[1][3].

Market Dynamics

Patient Population

Approximately 270,000 new cases of RCC are diagnosed worldwide each year, with about 20% presenting with advanced disease at diagnosis. This significant patient population creates a substantial market for TORISEL[3].

Competitive Landscape

The market for RCC treatments is competitive, with other targeted therapies such as bevacizumab and interferon alfa being used. However, TORISEL's unique mechanism of action and its approval for specific patient populations give it a distinct position in the market[3].

Combination Therapies

Studies have explored the combination of TORISEL with other therapies, such as bevacizumab. While these combinations have not always met their primary endpoints, they contribute to the ongoing research and development in the field, potentially expanding TORISEL's use in the future[4].

Financial Trajectory

Revenue Impact

TORISEL's financial performance is part of Pfizer's broader oncology portfolio. While specific revenue figures for TORISEL are not always disclosed separately, the drug contributes to Pfizer's overall biopharmaceutical revenues. For instance, Pfizer's global biopharmaceutical business saw significant revenue changes in recent years, influenced by various factors including the performance of other major drugs like Comirnaty and Paxlovid[2].

Market Exclusivity

TORISEL initially had orphan designations for RCC and mantle cell lymphoma, which provided market exclusivity for 10 years. These designations were withdrawn in 2017 and 2019, respectively, marking the end of the exclusivity period. This change could impact the drug's market dynamics as generic or biosimilar versions may enter the market[1].

Safety and Side Effects

The safety profile of TORISEL is crucial for its market and financial trajectory. Common side effects include infections, pneumonia, thrombocytopenia, anemia, and hyperglycemia. Serious side effects such as allergic reactions, lung disorders, and kidney failure can also occur. Managing these side effects is essential for maintaining patient compliance and overall market acceptance[1][3].

Cost and Resource Utilization

The treatment with TORISEL involves significant costs, including the drug itself, administration, and management of side effects. Studies have shown that the financial impact of treating metastatic RCC is substantial, and TORISEL, as a part of this treatment regimen, contributes to these costs[3].

Key Takeaways

• Mechanism and Efficacy: TORISEL inhibits mTOR, effectively slowing cancer cell growth and improving survival in advanced RCC and mantle cell lymphoma.
• Market Dynamics: TORISEL has a significant market presence due to its unique mechanism and approval for specific patient populations, despite a competitive landscape.
• Financial Trajectory: The drug's revenue is part of Pfizer's broader oncology portfolio, with its financial performance influenced by market exclusivity, competition, and the overall biopharmaceutical market.
• Safety and Side Effects: Managing side effects is crucial for patient compliance and market acceptance.
• Cost and Resource Utilization: TORISEL is a costly treatment, contributing to the overall financial burden of cancer care.

FAQs

What is TORISEL used for?

TORISEL is used for the treatment of advanced renal cell carcinoma (RCC) and mantle cell lymphoma.

How does TORISEL work?

TORISEL works by inhibiting the mammalian target of rapamycin (mTOR) protein, which is involved in cell division, growth, and survival.

What are the common side effects of TORISEL?

Common side effects include infections, pneumonia, thrombocytopenia, anemia, and hyperglycemia.

Is TORISEL approved for combination therapy?

While TORISEL is approved as a single-agent therapy, studies have explored its use in combination with other treatments like bevacizumab.

What is the financial impact of treating patients with TORISEL?

The financial impact is significant, including the cost of the drug, administration, and management of side effects, contributing to the overall cost of cancer care.

Sources

1. European Medicines Agency - Torisel | European Medicines Agency (EMA)
2. Pfizer - Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance
3. Pfizer - Pfizer Reports Results From Phase 3 Study Of Torisel (temsirolimus) In Combination With Bevacizumab In Advanced Renal Cell Carcinoma (RCC)
4. Pfizer - About TORISEL® (temsirolimus)