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:	68
Clinical Trials:	344
Patent Applications:	4,700
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
Regeneron Pharmaceuticals	Phase 2
Regeneron Pharmaceuticals	Phase 2/Phase 3
Liza Villaruz, MD	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	021462-001	Feb 4, 2004	AP	RX	Yes	Yes
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	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	7,772,209*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	5,217,974*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	7,772,209*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	5,344,932*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
Austria	359823
China	1055182
Denmark	0505640
Denmark	0432677
Denmark	1313508
Japan	H0597705	IMPROVED REMEDY
Spain	2284660

Supplementary Protection Certificates for ALIMTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	300181	Netherlands		300181, 20101210, EXPIRES: 20151209
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: 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	CA 2005 00008	Denmark
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 the Drug: ALIMTA

Introduction

ALIMTA, marketed by Eli Lilly and Company, is a chemotherapy drug used primarily for the treatment of pleural mesothelioma and non-small cell lung cancer. Here, we delve into the market dynamics and financial trajectory of ALIMTA, highlighting key factors influencing its performance.

Market Size and Growth

The global pemetrexed market, which includes ALIMTA, was valued at US$ 2,287.2 million in 2022. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.2% from 2022 to 2030, reaching a projected value of US$ 2,728.1 million by 2030[1].

Indications and Usage

ALIMTA is a folate analog metabolic inhibitor, often used in combination with other drugs for various indications. Its primary use is in the treatment of pleural mesothelioma and non-small cell lung cancer, making it a crucial component in oncology treatment regimens[1].

Distribution Channels

The market growth of ALIMTA is also influenced by distribution channels, particularly hospital pharmacies. The 340B program, which allows eligible health care organizations to purchase outpatient drugs at discounted prices, has boosted the demand for ALIMTA through hospital pharmacies[1].

Patent Expiry and Generic Competition

A significant factor affecting ALIMTA's financial trajectory is the expiry of its patents. In May 2022, ALIMTA lost its last U.S. patent, leading to a surge in generic competition. This resulted in a 63% decline in U.S. sales during the second quarter of 2022 compared to the same period in the previous year[4].

Financial Impact on Eli Lilly

The loss of patent protection and subsequent generic competition have had a notable impact on Eli Lilly's financial performance. During the second quarter of 2022, ALIMTA's sales decline contributed to a 4% overall sales drop for Eli Lilly, marking the company's first quarterly sales decline since the second quarter of 2020[4].

Revenue and Sales

In the second quarter of 2022, ALIMTA posted $228 million in U.S. sales, a significant drop from the previous year. This decline was partially offset by the strong performance of Eli Lilly's newer products, such as Mounjaro, Taltz, and Verzenio, which grew revenues by 20% during the quarter[4].

Earnings and Guidance

The financial impact of ALIMTA's decline led Eli Lilly to adjust its earnings per share guidance for 2022. The company reduced its expected earnings per share range from $7.30 to $7.45 to $6.96 to $7.11[4].

New Product Focus

Eli Lilly has been actively diversifying its product portfolio to mitigate the impact of ALIMTA's decline. The company has seen significant growth from its newer medicines, including Mounjaro, Zepbound, and other key growth products. These new launches have helped drive revenue growth, with new products contributing $2.19 billion to the company's revenue in Q4 2023[2][5].

Research and Development

Eli Lilly continues to invest heavily in research and development, with a focus on late-stage and early-stage assets. In Q4 2023, research and development expenses increased by 28% to $2.56 billion, reflecting the company's commitment to developing new treatments and mitigating the impact of declining sales from older products like ALIMTA[2][5].

Market Outlook

Despite the challenges posed by generic competition, the overall market for pemetrexed, including ALIMTA, remains stable due to its established use in oncology. However, the market dynamics are shifting, with a greater emphasis on innovative treatments and newer drug launches.

Competitive Landscape

The pemetrexed market includes several key players such as Stada Arzneimittel AG, Eagle Pharmaceuticals, Inc., Fresenius Kabi USA, and others. These companies are also navigating the challenges of generic competition while focusing on innovative products and strategies[1].

Key Takeaways

• Market Size and Growth: The global pemetrexed market is expected to grow at a CAGR of 2.2% from 2022 to 2030.
• Patent Expiry: The loss of patent protection for ALIMTA has led to significant generic competition and a decline in sales.
• Financial Impact: ALIMTA's decline has affected Eli Lilly's overall financial performance, but the company is offsetting this with strong growth from newer products.
• New Product Focus: Eli Lilly is diversifying its portfolio with successful new launches like Mounjaro and Zepbound.
• Research and Development: The company continues to invest heavily in R&D to develop new treatments.

FAQs

What is ALIMTA used for?

ALIMTA is used primarily for the treatment of pleural mesothelioma and non-small cell lung cancer.

How has the patent expiry affected ALIMTA's sales?

The patent expiry led to a 63% decline in U.S. sales during the second quarter of 2022 due to increased generic competition.

How is Eli Lilly offsetting the decline in ALIMTA sales?

Eli Lilly is offsetting the decline with strong growth from newer products such as Mounjaro, Taltz, and Verzenio.

What is the projected market size for pemetrexed by 2030?

The global pemetrexed market is projected to reach US$ 2,728.1 million by 2030.

How has Eli Lilly's financial performance been impacted by ALIMTA's decline?

Eli Lilly's overall sales declined by 4% in the second quarter of 2022, and the company adjusted its earnings per share guidance downward due to ALIMTA's decline.

Sources

1. Coherent Market Insights - Pemetrexed Market Size, Trends and Forecast to 2030
2. PR Newswire - Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Guidance
3. GitHub - Market-Research-Report-List-1/alimta-market.md
4. FiercePharma - Lilly's Alimta plunge drags on sales as new launches shine
5. Eli Lilly Investor Relations - Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Guidance