Pemetrexed ditromethamine - Generic Drug Details

What are the generic drug sources for pemetrexed ditromethamine and what is the scope of freedom to operate?

Pemetrexed ditromethamine is the generic ingredient in one branded drug marketed by Hospira and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for pemetrexed ditromethamine. One supplier is listed for this compound.

Summary for pemetrexed ditromethamine

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	pemetrexed ditromethamine at DailyMed

Pharmacology for pemetrexed ditromethamine

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pemetrexed ditromethamine

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for pemetrexed ditromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	PEMETREXED DITROMETHAMINE	pemetrexed ditromethamine	POWDER;INTRAVENOUS	208746-001	Jun 10, 2022		RX	Yes	Yes
Hospira	PEMETREXED DITROMETHAMINE	pemetrexed ditromethamine	POWDER;INTRAVENOUS	208746-003	Jun 10, 2022		DISCN	Yes	No
Hospira	PEMETREXED DITROMETHAMINE	pemetrexed ditromethamine	POWDER;INTRAVENOUS	208746-002	Jun 10, 2022		RX	Yes	Yes

Pemetrexed ditromethamine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pemetrexed Ditromethamine

Overview of Pemetrexed Ditromethamine

Pemetrexed ditromethamine, sold under the brand name Alimta by Eli Lilly and Company, is a chemotherapy drug used primarily for the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. It functions as a folate analog metabolic inhibitor, disrupting cell division and growth in cancer cells.

Global Market Size and Growth

As of 2024, the global pemetrexed market size is estimated to be USD 2.541 billion[1][3][4].

• This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.5% from 2024 to 2031, reaching approximately USD 3.020 billion by 2031[1].

Regional Market Breakdown

North America

• The North American market holds a significant share, with a market size of USD 1.016 billion in 2024. It is expected to grow at a CAGR of 0.7% from 2024 to 2031[1].
• The United States is the largest contributor within North America, with a market size of USD 802 million in 2024 and a CAGR of 0.5% from 2024 to 2031[1].

Europe

• Europe accounts for more than 30% of the global revenue, with a market size of USD 762.36 million in 2024. It is expected to grow at a CAGR of 1.0% from 2024 to 2031[1].

Asia-Pacific

• This region is the fastest-growing, with a market size of USD 584.48 million in 2024 and a CAGR of 4.5% from 2024 to 2031. The growth is driven by rapid industrialization, urbanization, and increasing healthcare expenditure in countries like China and India[1].

Latin America and Middle East & Africa

• Latin America accounts for around 5% of the global revenue, with a market size of USD 127.06 million in 2024 and a CAGR of 1.9% from 2024 to 2031[1].
• The Middle East and Africa hold a smaller share, with a market size of USD 50.82 million in 2024 and a CAGR of 2.2% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Prevalence of Cancer

• The rising incidence of lung cancer and mesothelioma globally is a significant driver. For instance, the American Cancer Society estimated about 235,760 new cases of lung cancer in the U.S. in 2021, with non-small cell lung cancer accounting for 80-85% of all lung cancer diagnoses[3].

Technological Advancements

• Advances in biopharmaceuticals and targeted therapies have enhanced the efficacy of pemetrexed, contributing to market growth[1].

Combination Therapies and Personalized Medicine

• The growing adoption of combination therapies and personalized medicine approaches has improved the treatment outcomes of pemetrexed, further boosting its demand[1].

Challenges and Constraints

Regulatory Approval Processes

• Stringent regulatory approval processes for new drug formulations pose challenges to market growth. These processes can delay the introduction of new treatments and impact the overall market expansion[1].

Dosage and Administration

Pemetrexed is administered intravenously, typically in combination with cisplatin for the initial treatment of NSCLC and mesothelioma. The recommended dose is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle, subject to certain conditions such as creatinine clearance and the absence of disease progression or unacceptable toxicity[2][5].

Clinical Trials and Safety

• The safety and efficacy of pemetrexed have been evaluated in several clinical trials, including the PARAMOUNT study, which focused on maintenance treatment following first-line pemetrexed plus platinum chemotherapy. This study highlighted the importance of folic acid and vitamin B12 supplementation to mitigate adverse reactions[2].

Adverse Reactions and Dose Modifications

• Common adverse reactions include hematologic and non-hematologic toxicities. Dose modifications are recommended based on the severity of these reactions, such as reducing the dose for myelosuppressive toxicity or withholding treatment for renal toxicity[2].

Market Share and Distribution Channels

• Hospital pharmacies play a crucial role in the distribution of pemetrexed, particularly due to programs like the 340B program, which boosts the growth of the market[4].

Key Takeaways

• The global pemetrexed market is driven by the increasing prevalence of lung cancer and mesothelioma, technological advancements, and the adoption of combination therapies.
• The market is expected to grow at a CAGR of 2.5% from 2024 to 2031.
• Regional growth varies, with Asia-Pacific being the fastest-growing region.
• Regulatory challenges and adverse reactions are key considerations for market growth and patient treatment.

FAQs

What is the current global market size for pemetrexed?

The global pemetrexed market size is estimated to be USD 2.541 billion in 2024[1].

What is the projected growth rate of the pemetrexed market?

The market is expected to grow at a CAGR of 2.5% from 2024 to 2031[1].

Which region is the fastest-growing in the pemetrexed market?

The Asia-Pacific region is the fastest-growing, with a CAGR of 4.5% from 2024 to 2031[1].

What are the primary indications for pemetrexed?

Pemetrexed is indicated for the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma, often in combination with cisplatin[2][5].

What are the common adverse reactions associated with pemetrexed?

Common adverse reactions include hematologic and non-hematologic toxicities, such as myelosuppression, renal toxicity, and mucositis[2].

Sources

1. Cognitive Market Research: Global Pemetrexed Market Report 2024.
2. FDA: Pemetrexed for Injection Label.
3. Straits Research: Pemetrexed Market Size, Share & Trends Analysis Report.
4. Coherent Market Insights: Pemetrexed Market Size, Trends and Forecast to 2030.
5. FDA: Pemetrexed Injection NDA Review.