ALIMTA Drug Patent Profile

When do Alimta patents expire, and when can generic versions of Alimta launch?

Alimta is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alimta

A generic version of ALIMTA was approved as pemetrexed disodium by ACCORD HLTHCARE on May 25^th, 2022.

Summary for ALIMTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	345
Patent Applications:	4,865
Drug Prices:	Drug price information for ALIMTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALIMTA
What excipients (inactive ingredients) are in ALIMTA?	ALIMTA excipients list
DailyMed Link:	ALIMTA at DailyMed

See drug prices for ALIMTA

Recent Clinical Trials for ALIMTA

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

Sponsor	Phase
Saint John's Cancer Institute	PHASE2
Chordoma Foundation	PHASE2
Regeneron Pharmaceuticals	Phase 2

See all ALIMTA clinical trials

Pharmacology for ALIMTA

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

Paragraph IV (Patent) Challenges for ALIMTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALIMTA	For Injection	pemetrexed disodium	750 mg/vial	021462	1	2016-10-06
ALIMTA	For Injection	pemetrexed disodium	1000 mg/vial	021462	1	2012-06-27
ALIMTA	For Injection	pemetrexed disodium	100 mg/vial	021462	1	2008-07-01
ALIMTA	For Injection	pemetrexed disodium	500 mg/vial	021462	2	2008-02-04

US Patents and Regulatory Information for ALIMTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	AP	RX	Yes	Yes
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	AP	RX	Yes	Yes

Expired US Patents for ALIMTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	5,217,974*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	5,344,932*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	5,217,974*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	5,344,932*PED

International Patents for ALIMTA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9107406
Japan	H0597705	IMPROVED REMEDY
Hungary	908147
Japan	3468534

Supplementary Protection Certificates for ALIMTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677	91147	Luxembourg		91147, EXPIRES: 20151210
0432677	C00432677/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920

Market Dynamics and Financial Trajectory for ALIMTA (Pemetrexed)

Last updated: December 15, 2025

Executive Summary

ALIMTA (pemetrexed) is a leading chemotherapeutic agent developed by Eli Lilly and Company, primarily approved for the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. Its revenue generation exhibits significant growth potential driven by expanding indications, geographic diversification, and emerging combination therapies. Conversely, patent expirations, pricing pressures, and increasing biosimilar competition pose risks that could influence its financial performance. This analysis offers a comprehensive overview of ALIMTA's market dynamics, forecasted trajectory, competitive landscape, and strategic considerations for stakeholders.

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Introduction

ALIMTA, a folate analog metabolic inhibitor, received FDA approval in 2004 for metastatic NSCLC and later expanded to mesothelioma in 2008. Its clinical efficacy hinges on multi-drug regimens, notably combined with platinum agents. As a cornerstone in oncology therapy, understanding its market evolution is crucial for investors, pharmaceutical strategists, and healthcare payers.

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Market Overview and Revenue Breakdown

Parameter	Details
Global Peak Sales (2022-2023)	Estimated at $1.5–2.0 billion annually
Major Markets	U.S., European Union, Japan, China
Primary Indications	NSCLC, Malignant Pleural Mesothelioma
Market Share (Oncology Drugs)	2-3% of global oncology market
Growth Rate (CAGR, 2023-2028)	Approx. 5-7% (driven by new indications)

Revenue Segmentation

Region	Revenue Share (2023)	Growth Drivers
United States	~50%	Established reimbursement, high NSCLC incidence
Europe	~30%	Expanding indications, pipeline approvals
Asia-Pacific	~15%	Rising cancer incidence, increasing access
Rest of World	~5%	Emerging markets, affordability considerations

Key Players and Market Share

Company	Product	Indications	Market Share	Notes
Eli Lilly	ALIMTA	NSCLC, Mesothelioma	~80%	Dominant in indication, patent protection
Competitors	N/A	Emerging biosimilars, generics	<20%	Limited presence due to patent exclusivity

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Market Drivers

Increasing Incidence of Lung Cancer and Mesothelioma

• Epidemiology Patterns: Lung cancer remains the leading cause of cancer-related deaths globally, with approximately 2.2 million new cases projected in 2023 [1].
• Ageing Population: Rising geriatric demographics increase susceptibility.
• Diagnostic Improvements: Enhanced screening protocols elevate detection rates.

Regulatory Approvals and Expanded Indications

• Breakthrough Therapy Designations: Facilitate accelerated approvals.
• Combination Regimens: Synergistic benefits in chemotherapy protocols boost utilization.
• New Formulations: Clinical trials exploring nanoparticle-based delivery systems aim to improve pharmacokinetics.

Pipeline and Emerging Therapies

• Bi-specific Antibodies, Checkpoint Inhibitors: Integration with immunotherapy (e.g., pembrolizumab plus ALIMTA) enhances patient outcomes [2].
• Biomarker-Driven Personalization: Facilitates tailored therapies, expanding potential indication scopes.

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Competitive Landscape

Aspect	Details
Patent Status	Patents valid until 2024–2026; impending generics entry expected
Biosimilar Development	Limited biosimilar options due to complex manufacturing
Market Entry Barriers	High development costs, regulatory hurdles, clinical trial requirements
Pricing Strategies	Premium pricing maintained via clinical value and brand reputation

Generic and Biosimilar Competition

Likely to erode revenue post-patent expiry, with generic pemetrexed formulations already available in certain regions. Some biosimilar candidates are in Phase III development, but manufacturing complexity delays their market entry [3].

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Financial Trajectory and Forecast

Timeframe	Projected Revenue (USD Billion)	Key Factors
2023	1.5–2.0	Stable across mature markets, minor price erosion
2024–2028	1.8–2.5 (CAGR: 5-7%)	Pipeline expansion, new indications, biosimilar entry
2029+	Potential decline post-patent expiration	Biosimilar competition, pricing pressures

Revenue Forecast Model (2023-2028)

Year	Revenue Estimate	Assumptions
2023	$1.7 billion	Continued demand, existing pipeline, minimal biosimilar impact
2024	$1.9 billion	Introduction of new indications, expanded regional access
2025	$2.1 billion	Uptick due to combination therapies, market expansion
2026	$2.3 billion	Peak utilization, approval of relevant trials
2027	$2.2 billion	Starting biosimilar competition affecting revenue
2028	$2.0 billion	Price erosion, biosimilar market stabilization

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Policy and Pricing Environment

Reimbursement Policies

• U.S.: Medicare and private payers cover ALIMTA, with outcome-based reimbursement models evolving.
• Europe: National health systems negotiate prices, with some regions adopting value-based approaches.
• Emerging Markets: Price caps and affordability measures influence access.

Pricing Trends

Period	Average Wholesale Price (AWP)	Trend
2004–2014	$3,000–$4,500 per 100 mg dose	Stable, premium pricing for innovation
2015–2023	Slight reductions due to negotiations	Price pressure post-patent expiry

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Strategic Considerations

• Pipeline Optimization: Focus on combination therapies with immunotherapies.
• Biosimilar Readiness: Early engagement to mitigate revenue decline.
• Geographic Diversification: Expand access in Asia and emerging markets.
• Regulatory Engagement: Leverage accelerated approvals for new indications.
• Market Penetration: Address unmet needs in refractory NSCLC and mesothelioma.

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Comparison with Competitors and Alternatives

Drug/Technology	Mechanism	Indications	Market Position
ALIMTA (Pemetrexed)	Antifolate inhibitor	NSCLC, Mesothelioma	Market leader in indication
Cisplatin	DNA crosslinker	Broadly used chemotherapeutic agents	Older, less targeted, generics
Nivolumab (Opdivo)	PD-1 inhibitor	NSCLC, Mesothelioma (combinatorial use)	Growing use, immunotherapy leader
Emerging Biosimilars	Various	Same indications	Price competition, generic entry

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Deep Dive: Impact of Patent Expiry

Year	Patent Expiry	Expected Impact	Mitigation Strategies
2024–2026	2024–2026	Significant generic/biosimilar competition, revenue decline	Diversify in emerging indications, focus on combination therapies
Post-Patent		Market share shifts to biosimilars, pressure on pricing	Early pipeline development, geographic expansion

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FAQs

Q1: What are the primary factors influencing ALIMTA's growth prospects?
A: Key factors include increasing global lung cancer incidence, expanded indications, combination therapy approvals, and regional market expansion. Conversely, patent expiration and biosimilar competition pose risks.

Q2: When is ALIMTA expected to face significant biosimilar competition?
A: Biosimilar pemetrexed is anticipated to penetrate markets by 2024–2026, leading to potential revenue erosion.

Q3: How does ALIMTA compare against emerging therapies?
A: ALIMTA remains a standard care in NSCLC and mesothelioma. New immunotherapies, such as PD-1 inhibitors, are increasingly used in combination, potentially reducing ALIMTA's prominence but also opening opportunities for dual regimens.

Q4: What regional strategies are critical for sustaining ALIMTA’s market share?
A: Expanding access in Asia-Pacific, obtaining favorable reimbursement policies, and customizing pricing strategies are essential.

Q5: How will the pipeline impact ALIMTA's long-term valuation?
A: Successful expansion into new indications or formulations could sustain or elevate revenue streams, mitigating the impact of patent expiry.

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Key Takeaways

• Market Dominance and Growth: ALIMTA holds a significant share in NSCLC and mesothelioma treatments, with steady growth forecasted at 5–7% annually through 2028.
• Patent and Biosimilar Risks: Patent expiration from 2024 onward is imminent, necessitating proactive diversification.
• Pipeline Expansion: Emphasis on combination therapies and new indications could extend product lifecycle and revenue.
• Global Expansion: Significant potential in emerging markets driven by rising cancer rates and evolving healthcare infrastructure.
• Regulatory and Pricing Dynamics: Market success depends on navigating diverse regulatory landscapes and maintaining favorable reimbursement.

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References

1. World Health Organization. (2023). Cancer Facts & Figures 2023.
2. National Cancer Institute. (2022). Use of Pemetrexed in Combination Therapy.
3. FDA. (2022). Biosimilar Pemetrexed Development Updates.