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ALIMTA

NDA

PEMETREXED DISODIUM | N021462 | ELI LILLY AND CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY v. GLENMARK GENERICS INC., USA 1:2014cv00104 1 patentANDA 205526pemetrexed disodium	INSD	2014-01-23	Terminated 2017-08-11	—
ELI LILLY AND COMPANY v. TEVA PARENTERAL MEDICINES, INC. et al 1:2010cv01376 2 patentsANDA 90-352, 90-674, 90-384, 91-111, 091111pemetrexed disodium	INSD	2010-10-29	Terminated 2015-08-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

50 trials from ClinicalTrials.gov — 35 recruiting, 10 active, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma NCT03228537	Phase 1	Active	National Cancer Institute (NCI)	28	2018-07-16 → 2026-09-18
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS NCT06008093	Phase 2	Active	AstraZeneca	103	2024-04-04 → 2028-02-28
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)NCT02194738	N/A	Active	National Cancer Institute (NCI)	8,300	2014-09-26 → 2026-09-28
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)NCT05555732	Phase 3	Active	Daiichi Sankyo	1,170	2023-01-11 → 2031-05-11
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing NCT05059522	Phase 3	Active	Pfizer	77	2021-09-29 → 2026-12-31
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)NCT06624059	Phase 1/2	Active	Hoffmann-La Roche	11	2024-11-18 → 2026-08-28
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer NCT06348199	Phase 3	Active	Samsung Bioepis Co., Ltd.	555	2024-03-12 → 2026-09
A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection NCT07128199	Phase 3	Active	Taiho Oncology, Inc.	360	2025-12-22 → 2032-10-01
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer NCT03793179	Phase 3	Active	National Cancer Institute (NCI)	600	2019-04-05 → 2027-09-30
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation NCT05609578	Phase 2	Active	Mirati Therapeutics Inc.	90	2022-11-22 → 2026-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Alimta (2023)

Total Spending

$2.1M

Total Claims

305

Beneficiaries

Avg Cost/Unit

$2433.79

Spending Trend

$9.0M(2019)→$9.7M(2020)→$9.8M(2021)→$7.4M(2022)→$2.1M(2023)

YoY Change:-1.4%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Alimta (2023)

Total Spending

$80.6M

Total Claims

62,237

Beneficiaries

14,547

ASP Price

—

HCPCS: J9305 — Injection, pemetrexed, not otherwise specified, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain12 active DMFs2 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

SHANDONG ANHONG PHARMACEUTICAL CO LTDPEMETREXED DISODIUM

DMF 233412009

CHEMWERTH INCPEMETREXED DISODIUM

DMF 234172009

DR REDDYS LABORATORIES LTDPEMETREXED DISODIUM (AMORPHOUS)

DMF 243882010

SHILPA PHARMA LIFESCIENCES LTDPEMETREXED DISODIUM (HEMIPENTA HYDRATE)

DMF 251022011

RELIANCE LIFE SCIENCES PVT LTDPEMETREXED DISODIUM

DMF 255592012

SUZHOU LIXIN PHARMACEUTICAL CO LTDPEMETREXED DISODIUM (NON STERILE)

DMF 256402011

LAURUS LABS LTDPEMETREXED DISODIUM

DMF 264312012

SUN PHARMACEUTICAL INDUSTRIES LTDPEMETREXED DISODIUM USP

DMF 266142012

SCINOPHARM TAIWAN LTDPEMETREXED DISODIUM USP

DMF 339502019

DR REDDYS LABORATORIES LTDPEMETREXED DISODIUM USP (HEPTAHYDRATE)

DMF 347542020

CHONGQING CARELIFE PHARMACEUTICAL CO LTDPEMETREXED DISODIUM

DMF 359892021

RAVI BIOLIFE PRIVATE LTDPEMETREXED DISODIUM USP

DMF 395232024

NEULAND LABORATORIES LTDInactivePEMETREXED DISODIUM (FORM IV)

DMF 256182011

ITF CHEMICAL LTDAInactivePEMETREXED DISODIUM EP

DMF 292862015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Sep 1, 2022	SUPPL -55	View Letter (PDF)
Feb 13, 2019	SUPPL -53	View Letter (PDF)
Jun 5, 2018	SUPPL -51	View Letter (PDF)
Apr 20, 2018	SUPPL -52	View Letter (PDF)
Oct 12, 2017	SUPPL -50	View Letter (PDF)
Sep 13, 2013	SUPPL -45	View Letter (PDF)
Nov 14, 2012	SUPPL -43	View Letter (PDF)
Oct 18, 2012	SUPPL -39	View Letter (PDF)
Jun 7, 2012	SUPPL -40	View Letter (PDF)
Nov 22, 2011	SUPPL -30	View Letter (PDF)
Nov 22, 2011	SUPPL -29	View Letter (PDF)
Nov 22, 2011	SUPPL -32	View Letter (PDF)
Mar 23, 2011	SUPPL -33	View Letter (PDF)
Jul 8, 2009	SUPPL -18	View Letter (PDF)
Jul 8, 2009	SUPPL -22	View Letter (PDF)
Jul 8, 2009	SUPPL -21	View Letter (PDF)
Oct 1, 2008	SUPPL -15	View Letter (PDF)
Sep 11, 2007	SUPPL -12	View Letter (PDF)
Feb 12, 2007	SUPPL -6	View Letter (PDF)
Aug 4, 2006	SUPPL -4	View Letter (PDF)
Aug 25, 2004	SUPPL -1	View Letter (PDF)
Feb 5, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Feb 4, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE/VIAL

RLDAP

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Sep 7, 2007