ALIMTA Drug Patent Profile

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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. Nineteen 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALIMTA

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

International Patents for ALIMTA

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

Country	Patent Number	Title	Estimated Expiration
Austria	126700
Australia	640524
Australia	8457091

Supplementary Protection Certificates for ALIMTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	91147	Luxembourg		91147, EXPIRES: 20151210
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677	300181	Netherlands		300181, 20101210, EXPIRES: 20151209

Last updated: February 3, 2026

What is ALIMTA and what is its market position?

ALIMTA (pemetrexed disodium) is an antifolate chemotherapy drug approved for treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. It was developed by Eli Lilly and received FDA approval in 2004 for mesothelioma and in 2008 for NSCLC. The drug's global sales peaked at approximately $1.8 billion in 2017 and have since faced generic competition.

What are the key indications for ALIMTA?

ALIMTA is indicated in combination with platinum-based chemotherapy for:

• First-line treatment of malignant pleural mesothelioma.
• First-line treatment of nonsquamous non-small cell lung cancer.

It is also used in maintenance therapy after initial chemotherapy.

How does ALIMTA perform commercially?

Sales trends indicate a peak around 2017, followed by declines as patent protections expired in the U.S. in 2019 and in other markets subsequently. Lilly’s global net sales declined from $1.8 billion in 2017 to approximately $900 million in 2021. The drug faces strong generic competition, reducing margins and impacting revenue streams.

What are the patent and regulatory protections affecting ALIMTA?

ALIMTA's primary patent protections expired in the U.S. in 2019, allowing generics to enter the market. Global patent expiry varied, with Europe ending in 2021 in some markets. Lilly has pursued patent extensions and supplementary protection certificates but with limited success. The loss of exclusivity has increased generic competition.

What are the major competitors and alternatives?

• Generic pemetrexed formulations: Lower-cost alternatives rapidly eroded Lilly’s market share post-patent expiry.
• Other chemotherapies: Cisplatin and carboplatin can be used in similar indications; targeted therapies for NSCLC (e.g., EGFR, ALK inhibitors) are also standard choices.
• Emerging drugs and immunotherapies: PD-1/PD-L1 inhibitors (e.g., pembrolizumab) have gained prominence, further challenging pemetrexed’s market position.

What future sales and revenue potential exist for ALIMTA?

Given patent expiration and increased generic penetration, the revenue trajectory is declining. However, Lilly has initiatives to expand indications, including potential combination regimens with immunotherapies. Limited pipeline expansion for pemetrexed suggests future growth potential is constrained.

What R&D investments or pipeline developments are associated with ALIMTA?

Lilly explores combination therapies involving ALIMTA, particularly with immunomodulators, to recapture market share through new indications or improved efficacy. No significant development of new formulations or derivatives of pemetrexed is publicly reported, indicating limited pipeline expansion for ALIMTA itself.

What are the key investment considerations?

• Valuation Risks: Current sales decline suggest reduced revenue streams, impacting valuation.
• Patent Cliff Impact: Loss of exclusivity in key markets poses significant price and volume erosion.
• Competitive Pressure: The rise of immunotherapies and generics increases pricing pressure.
• Pipeline Opportunities: Limited pipeline of pemetrexed derivatives but ongoing combination trials could provide moderate upside.

What is the outlook for ALIMTA investment?

The outlook depends on how effectively Lilly manages patent expirations and if it can generate renewed demand via combination treatments. Investors should consider the drug's declining patent protection, intense generic competition, and the shift towards immunotherapy-dominated treatment paradigms for lung cancer and mesothelioma.

Key Takeaways

• ALIMTA is an established chemotherapeutic agent with peak sales around $1.8 billion in 2017; revenues have decreased sharply post-patent expiry.
• Patent expirations and generics have led to significant revenue declines, with global sales dropping to under $1 billion in 2021.
• The drug faces competition from both generic formulations and emerging immunotherapy options, which have redefined treatment standards.
• Lilly’s pipeline focus on combination therapies offers some potential but limited prospects for substantial revenue recovery.
• Investment risks center on patent cliffs, market share erosion, and the shifting landscape towards personalized immunotherapy treatments.

FAQs

1. When did the patent expiry for ALIMTA occur in the major markets?
The U.S. patent expired in 2019, with European markets ending patent protections in 2021.

2. What are the primary drivers of ALIMTA’s revenue decline?
Patent expiry, generic competition, and the rise of immunotherapy options have driven revenue declines.

3. Are there ongoing clinical trials involving ALIMTA?
Yes. Lilly is testing ALIMTA in combination with immunotherapies for NSCLC and mesothelioma but has limited pipeline expansion for pemetrexed itself.

4. Can ALIMTA regain market share?
Limited prospects exist unless new indications or combination therapies prove significantly more effective and are approved.

5. How does ALIMTA compare to emerging targeted therapies?
Targeted therapies and immunotherapies currently dominate treatment for NSCLC, reducing ALIMTA’s role in future treatment landscapes.[1]

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References

1. Eli Lilly Annual Reports, 2017-2022.
2. FDA drug approval archives.
3. IQVIA Sales Data, 2017-2021.