PEMETREXED Drug Patent Profile

When do Pemetrexed patents expire, and what generic alternatives are available?

Pemetrexed is a drug marketed by Actavis, Shilpa, 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, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz. and is included in twenty-six NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are twenty-nine drug master file entries for this compound. Additional details are available on the pemetrexed ditromethamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Pemetrexed

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PEMETREXED

International Patents:	1
US Patents:	1
Applicants:	21
NDAs:	26
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	1,098
Patent Applications:	3,306
Drug Prices:	Drug price information 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

Recent Clinical Trials for PEMETREXED

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

Sponsor	Phase
Guangzhou Medical University	PHASE1
Chugai Pharmaceutical	PHASE3
Swiss Cancer Institute	PHASE2

See all PEMETREXED clinical trials

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

PEMETREXED is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nang Kuang Pharm Co	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	207352-002	May 25, 2022	AP	RX	No	No
Hospira	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	202111-001	May 25, 2022		DISCN	No	No
Zydus Pharms	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214073-001	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/000564Malignant 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/003958Malignant 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/003788Malignant 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

International Patents for PEMETREXED

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016151365

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

Market Dynamics and Financial Trajectory for Pemetrexed

Last updated: July 28, 2025

Introduction

Pemetrexed, marketed notably under the brand names Alimta and others, is a chemotherapy agent primarily used for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. Its development by Eli Lilly and subsequent regulatory approvals have positioned it as a significant contender within the oncology therapeutics landscape. Analyzing the market dynamics and financial trajectory for pemetrexed offers insights into its current positioning, potential growth prospects, and strategic considerations for stakeholders in the pharmaceutical sector.

Market Overview and Therapeutic Positioning

Pemetrexed functions as an antifolate chemotherapeutic agent, inhibiting folate-dependent enzymes critical for DNA synthesis and cell replication. Its approval in 2004 by the FDA for NSCLC marked a milestone, particularly for non-squamous subtypes, complementing platinum-based regimens. Subsequently, approval expanded to mesothelioma, cementing its therapeutic relevance. The drug's unique mechanism and clinical efficacy have sustained its relevance despite the competitive oncology landscape dominated by targeted therapies and immuno-oncology agents.

Market Size and Revenue Generation

Global sales of pemetrexed have experienced consistent growth, reflecting its core role in lung cancer treatment. According to IQVIA data, the drug generated approximately $1.8 billion in worldwide sales in 2022, with North America accounting for over 60% of revenues. The growth trajectory is driven by increasing lung cancer incidence globally, particularly in aging populations, and expansion of indications into first-line and maintenance settings.

While some markets face generic competition, patent landscapes remain favorable in key regions. The original patent expired in the US in 2019; however, manufacturing exclusivities and subsequent formulation patents have helped maintain profitability. Additionally, the recognition of pemetrexed’s cost-effectiveness in combination regimens sustains its demand in clinical practice.

Patent and Regulatory Landscape

The patent exclusivity, granted in multiple jurisdictions, provided a period of market protection until patent expiration in the US, with EU and other markets following similar timelines. Following patent expiry, biosimilar and generic entry is anticipated to influence pricing and market share. Nevertheless, strategic patent filings on specific formulations and dosing regimens effectively prolong commercial exclusivity.

Regulatory agencies worldwide have approved pemetrexed for additional indications, including for use in combination with immunotherapies like pembrolizumab, which broadens its potential patient population and aligns with trends toward combination regimens in oncology.

Competitive Dynamics and Emerging Alternatives

The oncology market’s competitive landscape features several agents targeting NSCLC and mesothelioma, such as immune checkpoint inhibitors (nivolumab, pembrolizumab), targeted therapies (EGFR and ALK inhibitors), and other antifolates in development. The advent of immunotherapy has shifted the treatment paradigm, often relegating pemetrexed to combination roles or maintenance therapy.

However, pemetrexed maintains a distinct niche due to its established efficacy, safety profile, and cost-effectiveness. The emergence of biosimilars and generics will further pressure pricing, compelling manufacturers to pursue cost reductions and novel combination strategies to sustain market share.

Financial Trajectory and Future Outlook

Looking ahead, the financial trajectory of pemetrexed appears influenced by multiple factors:

• Market Penetration and Adoption: Continued acceptance of pemetrexed in combination regimens, especially with immune checkpoint inhibitors, enhances its revenue potential. The approval of combination standards sector-wide facilitates sustained demand.

• Biosimilar Entry: Anticipated biosimilars in developed markets post-patent expiration could trigger price erosion by 20-40%, as observed with other chemotherapeutic agents (e.g., bevacizumab biosimilars). This could diminish per-unit revenue but expand market access due to lower prices.

• Geographic Expansion: Increased access in emerging markets, driven by cost-effectiveness and burgeoning lung cancer burdens, presents growth prospects. Strategic partnerships and licensing agreements may facilitate market entry into Asia, Latin America, and Africa.

• Pipeline and New Indications: Ongoing clinical trials exploring pemetrexed’s role in neoadjuvant settings, maintenance therapy, and with novel agents could open additional revenue streams. The development of immunotherapy combinations is particularly promising.

• Regulatory and Pricing Pressures: Governments and payers’ emphasis on cost containment and value-based pricing could influence reimbursement policies, impacting overall profitability.

Strategic Considerations

For industry stakeholders, balancing patent management with generic competition is vital. Developing proprietary formulations, extending patent life through new dosing schedules, and investing in combination therapies are viable strategies. Moreover, pursuing clinical trials to establish new indications or synergistic regimens can sustain pemetrexed’s relevance.

Furthermore, partnerships with biosimilar producers, negotiation for favorable reimbursement, and geographic expansion are instrumental for long-term financial stability. Business models emphasizing cost-efficiency, alongside innovation, will define pemetrexed’s trajectory in an increasingly competitive landscape.

Conclusion

The market dynamics for pemetrexed are multifaceted, reflecting its established efficacy, evolving competitive landscape, and shifting regulatory environment. While patent expirations pose challenges through biosimilar entry, strategic innovation and expanding indications offer pathways to sustained revenue growth. The drug’s future financial trajectory hinges on its integration into combination regimens, geographic expansion, and adaptation to payer and regulatory frameworks.

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Key Takeaways

• Strong Position in Lung Cancer: Pemetrexed remains a critical component of NSCLC and mesothelioma treatment, with steady revenue contributions driven by global lung cancer prevalence.

• Patent and Competition Landscape: Patent expirations have introduced biosimilars and generics, necessitating strategic repositioning through new formulations and combination therapies.

• Market Expansion: Emerging markets and expanded indications, especially in combination with immunotherapies, offer growth opportunities amid the evolving oncology landscape.

• Cost and Reimbursement Strategies: Cost-effectiveness and value-based pricing will be central in maintaining market access, especially in regions with aggressive payer negotiations.

• Innovation and Pipeline Development: Clinical trials exploring new indications and regimens will be pivotal in extending pemetrexed’s commercial viability and enhancing its financial trajectory.

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FAQs

Q1: How does patent expiration impact pemetrexed’s market share and pricing?
Patent expiration leads to biosimilar and generic entry, typically causing a significant decrease in drug prices—often by 20-40%—and shrinking market share for originator products. However, strategic patent protections on formulations and combinations can temporarily mitigate these effects.

Q2: What are the main competitors to pemetrexed in its approved indications?
While pemetrexed’s primary competitors include other chemotherapeutic agents and combination regimens, its main rivals are emerging immunotherapies like pembrolizumab and nivolumab, which are increasingly used as front-line treatments. Targeted therapies also compete in specific genetic subpopulations.

Q3: What future developments could influence pemetrexed’s market?
New clinical trials investigating pemetrexed in different treatment settings, novel combination therapies (especially with immunotherapies), and expanded indications could boost its market. Conversely, rapid adoption of alternative treatments and biosimilars could challenge its dominance.

Q4: How has the integration of immunotherapy affected pemetrexed's role in treatment?
Immunotherapies have shifted treatment paradigms toward immune checkpoint inhibitors, often in combination with chemotherapy like pemetrexed. This synergy enhances pemetrexed’s utility and maintains its relevance in first-line settings.

Q5: What strategies should manufacturers adopt to sustain pemetrexed’s profitability post-patent expiration?
Manufacturers should focus on developing new formulations, securing additional patents, fostering strategic partnerships, expanding into new markets, and advocating for reimbursement policies that recognize the drug’s value in combination regimens.

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References

1. IQVIA. "Global Oncology Market Report 2022."
2. U.S. Food and Drug Administration (FDA). "Alimta (pemetrexed) Prescribing Information."
3. European Medicines Agency (EMA). "Pemetrexed Summary of Product Characteristics."
4. MarketWatch. "Pemetrexed Market Analysis and Forecasts 2022–2027."
5. ClinicalTrials.gov. "Ongoing Trials with Pemetrexed in Oncology."