Pemetrexed - Generic Drug Details

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

Pemetrexed is the generic ingredient in five branded drugs marketed by Actavis, Eagle Pharms, Avyxa Holdings, Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-nine NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemetrexed has seven patent family members in five countries.

There are twenty-nine drug master file entries for pemetrexed. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for pemetrexed

International Patents:	7
US Patents:	3
Tradenames:	5
Applicants:	24
NDAs:	29
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	963
Patent Applications:	7,468
Drug Prices:	Drug price trends for pemetrexed
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pemetrexed
What excipients (inactive ingredients) are in pemetrexed?	pemetrexed excipients list
DailyMed Link:	pemetrexed at DailyMed

See drug prices for pemetrexed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pemetrexed

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for pemetrexed

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
MSD Italia S.r.l.	Phase 2
Istituto Oncologico Veneto IRCCS	Phase 2

See all pemetrexed clinical trials

Generic filers with tentative approvals for PEMETREXED

Applicant	Application No.	Strength	Dosage Form
		500MG	INJECTABLE;INJECTION
		1G	INJECTABLE;INJECTION
		500MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pemetrexed

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

Anatomical Therapeutic Chemical (ATC) Classes for pemetrexed

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

US Patents and Regulatory Information for pemetrexed

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214408-001	Jul 19, 2022		RX	Yes	Yes
Hospira	PEMETREXED DITROMETHAMINE	pemetrexed ditromethamine	POWDER;INTRAVENOUS	208746-002	Jun 10, 2022		RX	Yes	Yes
Qilu Pharm Hainan	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	204890-001	May 25, 2022	AP	RX	No	No
Zydus Pharms	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214073-003	May 25, 2022	AP	RX	No	No

EU/EMA Drug Approvals for pemetrexed

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Alimta	pemetrexed	EMEA/H/C/000564 Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2004-09-20
KRKA d.d.	Pemetrexed Krka	pemetrexed	EMEA/H/C/003958 Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2018-05-22
Menarini International Operations Luxembourg S.A.	Ciambra	pemetrexed	EMEA/H/C/003788 Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-12-02
Fresenius Kabi Deutschland GmbH	Pemetrexed Fresenius Kabi	pemetrexed	EMEA/H/C/003895 Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2016-07-22

International Patents for pemetrexed

Country	Patent Number	Title	Estimated Expiration
Taiwan	201619161	Crystalline forms of pemetrexed diacid and manufacture processes therefor
Canada	2962383	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Canada	3015436	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
European Patent Office	3212193	FORMES CRISTALLINES DU DIACIDE DE PÉMÉTREXED ET LEURS PROCÉDÉS DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)

Supplementary Protection Certificates for pemetrexed

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920

Pemetrexed Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pemetrexed

Overview of Pemetrexed

Pemetrexed, marketed under the brand name Alimta, is a chemotherapy drug used primarily in the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer (NSCLC). The drug has been a significant player in the oncology market, driven by its efficacy and the increasing prevalence of lung cancer and mesothelioma globally.

Global Market Size and Growth

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

• This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.50% from 2024 to 2031, reaching approximately USD 3.020 billion by 2031[1].

Regional Market Breakdown

The global pemetrexed market is segmented into several key regions:

North America

• North America dominates the global market, accounting for more than 40% of the global revenue 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 market within North America, with a sales revenue of USD 802 million in 2024 and a CAGR of 0.5% from 2024 to 2031[1].

Europe

• Europe holds around 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].
• Key European markets include the UK, France, and Germany, each with their own growth rates and market sizes[1].

Asia Pacific

• The Asia Pacific region accounts for around 23% of the global revenue, with a market size of USD 584.48 million in 2024. This region is expected to be the fastest-growing, with a CAGR of 4.5% from 2024 to 2031[1].

Latin America and Middle East & Africa

• Latin America contributes 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 account for around 2% of the global revenue, 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 Lung Cancer and Mesothelioma

• The rising incidence of lung cancer and mesothelioma globally is a significant driver for the pemetrexed market. Lung cancer remains one of the most common and deadliest types of cancer, with high incidence rates linked to smoking, environmental pollutants, and occupational hazards[1][3].

Technological Advancements and Treatment Demand

• The demand for advanced cancer treatments, including chemotherapy drugs like pemetrexed, is increasing due to the limited efficacy of traditional treatments and the need for more effective therapies[1][3].

Government Initiatives and Favorable Policies

• Government initiatives and favorable policies, such as the approval of novel indications and the launch of generic versions at lower prices, are expected to boost the adoption of pemetrexed[5].

Financial Considerations

Cost-Effectiveness and Economic Models

• The cost-effectiveness of pemetrexed is a critical factor in its adoption. For instance, in the UK, a commercial access agreement with NHS England makes pemetrexed available at a reduced cost for continuation maintenance treatment, enhancing its economic viability[2].

Treatment Costs

• The average total treatment cost for pemetrexed, assuming 8 cycles of treatment, is approximately £11,520 in the UK. This includes the cost of the drug and necessary concomitant medications like vitamin supplements and dexamethasone[2].

Emerging Trends and Opportunities

Clinical Trials and New Indications

• Recent clinical trials have shown promising results for pemetrexed in treating other types of cancer, such as chordoma. A pilot study indicated that pemetrexed can stabilize or shrink tumors in patients with recurrent or advanced chordoma, opening up new potential markets[4].

Combination Therapies

• The effectiveness of pemetrexed in combination with other treatments, such as immunotherapies like pembrolizumab (Keytruda), is being explored. This could enhance the drug's efficacy and expand its use in various cancer types[4].

Challenges and Restraints

COVID-19 Impact

• The COVID-19 pandemic has had a significant impact on the global economy, including disruptions in production, demand, and supply chains. This has affected the pemetrexed market, particularly in 2020[5].

Side Effects and Tolerability

• While pemetrexed has a well-established tolerability profile, the potential for side effects and the need for concomitant medications can be a restraint. However, the introduction of free supplementation packs in some regions has mitigated some of these concerns[2].

Key Takeaways

• The global pemetrexed market is driven by the increasing prevalence of lung cancer and mesothelioma.
• North America dominates the market, but the Asia Pacific region is expected to be the fastest-growing.
• Government initiatives, technological advancements, and the launch of generic versions are key drivers.
• The drug's cost-effectiveness and emerging trends in combination therapies are crucial for its continued growth.
• Challenges such as the COVID-19 pandemic and side effects need to be managed.

FAQs

What is the current global market size for pemetrexed?

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

What is the projected growth rate for the pemetrexed market from 2024 to 2031?

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.50% from 2024 to 2031[1].

Which region dominates the global pemetrexed market?

North America dominates the global market, accounting for more than 40% of the global revenue[1].

What are the primary drivers of the pemetrexed market?

The primary drivers include the increasing prevalence of lung cancer and mesothelioma, technological advancements, and government initiatives[1][3][5].

Are there any new indications or emerging trends for pemetrexed?

Yes, recent clinical trials have shown promising results for pemetrexed in treating chordoma, and combination therapies with immunotherapies are being explored[4].

How has the COVID-19 pandemic affected the pemetrexed market?

The COVID-19 pandemic has caused disruptions in production, demand, and supply chains, significantly impacting the global economy and the pemetrexed market, particularly in 2020[5].

Sources

1. Cognitive Market Research: Global Pemetrexed Market Report 2024.
2. National Institute for Health and Care Excellence: Final appraisal determination – pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin.
3. Straits Research: Pemetrexed Market Size, Share & Trends Analysis Report By 2024-2031.
4. Chordoma Foundation: New clinical trial results suggest that pemetrexed is effective for patients with recurrent or advanced chordoma.
5. Allied Market Research: Pemetrexed Market Size, Trends And Industry Opportunity 2027.