TEMODAR Drug Patent Profile

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

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Temodar

A generic version of TEMODAR was approved as temozolomide by SUN PHARM on February 12^th, 2014.

Summary for TEMODAR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	304
Patent Applications:	3,287
Drug Prices:	Drug price information for TEMODAR
What excipients (inactive ingredients) are in TEMODAR?	TEMODAR excipients list
DailyMed Link:	TEMODAR at DailyMed

See drug prices for TEMODAR

Recent Clinical Trials for TEMODAR

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 1/Phase 2
Xynomic Pharmaceuticals, Inc.	Phase 1
Orbus Therapeutics, Inc.	Phase 1

See all TEMODAR clinical trials

Pharmacology for TEMODAR

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for TEMODAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEMODAR	Capsules	temozolomide	140 mg and 180 mg	021029	1	2008-03-24
TEMODAR	Capsules	temozolomide	5 mg, 20 mg, 100 mg and 250 mg	021029	1	2007-03-20

US Patents and Regulatory Information for TEMODAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009		RX	Yes	Yes
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-002	Aug 11, 1999		DISCN	Yes	No

Expired US Patents for TEMODAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-006	Oct 19, 2006

EU/EMA Drug Approvals for TEMODAR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH	Temomedac	temozolomide	EMEA/H/C/001124 Temomedac hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-01-25
Accord Healthcare S.L.U.	Temozolomide Accord	temozolomide	EMEA/H/C/001125 For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-03-15
Sun Pharmaceutical Industries Europe B.V.	Temozolomide Sun	temozolomide	EMEA/H/C/002198 Temozolomide Sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2011-07-13
Teva B.V.	Temozolomide Teva	temozolomide	EMEA/H/C/001126 For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-01-28

International Patents for TEMODAR

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5843975	TETRAZINE DERIVATIVE
Russian Federation	2148401	PHARMACEUTICAL COMPOSITION SHOWING ANTITUMOR ACTIVITY AND METHOD OF ITS PREPARING
Canada	1197247	PROCEDE POUR LA PREPARATION DE NOUVEAUX DERIVES D'IMIDAZOTETRAZINONES ET LES DERIVES AINSI OBTENUS (PREPARATION PROCESS OF NEW IMIDAZOTETRAZINONE DERIVATIVES THUS OBTAINED)
Israel	66606	4-OXO-3H-IMIZADO(5,1-D)1,2,3,5-TETRAZINE-8-CARBOXAMIDE DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

TEMODAR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Temozolomide (Temodar)

Market Overview

Temozolomide, marketed under the brand name Temodar, is a chemotherapy drug used primarily for the treatment of certain types of brain tumors, including glioblastoma and anaplastic astrocytoma. Here is a comprehensive look at the market dynamics and financial trajectory of this crucial oncology drug.

Global Market Size and Growth

As of 2022, the global Temozolomide market reached a value of USD 8,593.27 million. It is projected to grow to USD 9,705.2 million by 2028, exhibiting a Compound Annual Growth Rate (CAGR) of 2.05% during the forecast period[1].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global Temozolomide market. The outbreak disrupted the global supply chain, leading to delays in raw material shipments and increased transportation costs. Many pharmaceutical companies suspended or postponed their production plans, affecting the supply of Temozolomide. However, as the pandemic eases, the market is expected to recover, driven by the increasing demand for brain cancer treatments[1].

Strengths and Weaknesses

Strengths

• Temozolomide is currently the most effective drug for treating low-grade and high-grade gliomas.
• It has a huge potential market due to the increasing prevalence of neurological diseases worldwide.
• The drug benefits from a rich downstream industry, including hospitals, clinics, and other healthcare facilities[1].

Weaknesses

• Temozolomide has several side effects, including nausea, vomiting, constipation, loss of appetite, hair loss, headache, fatigue, and convulsions. These side effects can impact patient compliance and overall market growth[1].

Opportunities

Technological Innovation

Technological advancements in drug delivery and formulation are expected to enhance the efficacy and safety of Temozolomide. Innovations such as targeted therapies and combination regimens could further expand the market[1][5].

Increasing Prevalence of Neurological Diseases

The global increase in neurological diseases, particularly brain cancers, presents a significant opportunity for the Temozolomide market. As the population ages and the incidence of brain tumors rises, the demand for effective treatments like Temozolomide is likely to grow[1].

Industrial Integration

Mergers and acquisitions, as well as strategic partnerships, can strengthen the market position of key players. For example, Mayne Pharma's acquisition of generic pharmaceutical products from Teva Pharmaceutical Industries expands its therapeutic focus, including oncology[1].

Segment Analysis

By Type

The Temozolomide market is primarily split into two segments: Temozolomide Capsules and Temozolomide Injection. The Temozolomide Injection segment is anticipated to contribute the largest market share by 2027[1][3].

By Downstream Industry

The market is segmented into hospitals, clinics, and other healthcare facilities. Hospitals are expected to be the major consumers due to the need for specialized care and treatment for brain cancer patients[1].

Regional Analysis

Geographical Distribution

The global Temozolomide market is analyzed across several regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region had the highest growth rate among all regions, driven by increasing healthcare expenditure and a growing patient population[1].

Key Companies

Major players in the Temozolomide market include Merck & Co, Tianjin Tasly Pharmaceutical Co, Sun Pharma, SL PHARM, and Teva Pharmaceutical Industries. Merck & Co holds a significant market share, accounting for 23.92% of the global market in 2022[1].

Regulatory Updates

FDA Approvals

On September 14, 2023, the FDA approved updated labeling for Temozolomide under Project Renewal, an initiative aimed at updating labeling information for older oncology drugs. The new indications include adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma. The dosage regimen and patient counseling information were also revised[4].

Financial Performance

The financial performance of the Temozolomide market is closely tied to the overall demand for brain cancer treatments and the competitive landscape. Here are some key financial metrics:

• Market Size: The global Temozolomide market was valued at USD 8,593.27 million in 2022 and is projected to reach USD 9,705.2 million by 2028[1].
• CAGR: The market is expected to grow at a CAGR of 2.05% from 2022 to 2028[1].
• Revenue Share: Merck & Co, one of the major players, held a 23.92% market share in 2022[1].

Market Trends

Combination Therapies

There is a growing trend towards combination therapies, including targeted therapies, to enhance the efficacy of Temozolomide. For instance, a study showed promising results with a targeted combination therapy for glioblastoma, highlighting the potential for future growth in this area[5].

Technological Advancements

Advancements in drug delivery systems and formulations are expected to improve the safety and efficacy of Temozolomide. These innovations could lead to better patient outcomes and increased market demand.

Challenges and Restraints

Side Effects

The side effects associated with Temozolomide, such as nausea, vomiting, and fatigue, can impact patient compliance and overall market growth. Managing these side effects through better patient care and supportive therapies is crucial.

Regulatory Environment

Changes in regulatory environments and the need for continuous updates to drug labeling can pose challenges. However, initiatives like the FDA's Project Renewal help keep labeling information up-to-date and clinically relevant[4].

Key Takeaways

• The global Temozolomide market is valued at USD 8,593.27 million in 2022 and is expected to grow to USD 9,705.2 million by 2028.
• The market is driven by the increasing prevalence of brain cancers and technological innovations in drug delivery.
• Major players like Merck & Co dominate the market, with a significant share.
• Regulatory updates, such as those under the FDA's Project Renewal, are crucial for maintaining the market's growth trajectory.
• Combination therapies and targeted treatments are emerging trends that could further expand the market.

FAQs

What is the primary use of Temozolomide?

Temozolomide is primarily used to treat certain types of brain tumors, including glioblastoma and anaplastic astrocytoma.

How did the COVID-19 pandemic affect the Temozolomide market?

The COVID-19 pandemic disrupted the global supply chain, leading to delays and increased costs. However, the market is expected to recover as the pandemic eases.

Which segment is expected to contribute the largest market share in the Temozolomide market?

The Temozolomide Injection segment is anticipated to contribute the largest market share by 2027.

What are the new indications approved for Temozolomide by the FDA?

The FDA approved new indications for Temozolomide, including adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma, under Project Renewal.

Which region has the highest growth rate in the Temozolomide market?

The Asia Pacific region has the highest growth rate among all regions, driven by increasing healthcare expenditure and a growing patient population.

Sources

1. Global Temozolomide Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029. MarketResearch.com.
2. US securities & Exchange commission form 20-F 2013 - Novartis. Novartis.
3. Temozolomide Market Report 2024 (Global Edition). Cognitive Market Research.
4. FDA approves new and updated indications for temozolomide under Project Renewal. FDA.
5. Targeted Combo Notches Rare Success in Glioblastoma. OncLive.