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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	S.D. Ind.	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	S.D. Ind.	2010-10-29	Terminated 2015-08-25	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Hyman Phelps McNamara PC - Citizen Petition FDA-2012-P-1259 · 3 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Pemetrexed Disodium for Injection, 750 mg/vial, suitable for submission in an Abbreviated New Drug Application, wit	Other	2012-12-30	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

441 trials from ClinicalTrials.gov — 14 recruiting, 41 active, 231 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors NCT04083599	Phase 1/2	Active	Genmab	350	2019-09-17 → 2026-11
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
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)NCT02542293	Phase 3	Active	AstraZeneca	953	2015-11-03 → 2026-12-31
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)NCT03944772	Phase 2	Active	AstraZeneca	247	2019-06-25 → 2025-05-06
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)NCT02817633	Phase 1	Active	Tesaro, Inc.	463	2016-07-08 → 2027-03-01
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer NCT01993810	Phase 3	Active	Radiation Therapy Oncology Group	330	2014-01-03 → 2028-11-30
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)NCT03178552	Phase 2/3	Active	Hoffmann-La Roche	1,000	2017-09-22 → 2026-10-31
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)NCT03425643	Phase 3	Active	Merck Sharp & Dohme LLC	797	2018-04-24 → 2026-06-29
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma NCT01878617	Phase 2	Active	St. Jude Children's Research Hospital	660	2013-06-23 → 2031-10-13
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC NCT03819465	Phase 1	Active	AstraZeneca	175	2018-12-27 → 2026-07-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$605.28

Highest Price

$4063.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-7623-01ALIMTA 500MG/VIL INJ	$4063.32	FSS	Eli Lilly & Company	09/28/2030
00002-7623-01ALIMTA 500MG/VIL INJ	$3026.36	Big4	Eli Lilly & Company	09/28/2030
00002-7640-01ALIMTA 100MG/VIL INJ	$812.66	FSS	Eli Lilly & Company	09/28/2030
00002-7640-01ALIMTA 100MG/VIL INJ	$605.28	Big4	Eli Lilly & Company	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Alimta (2024)

Total Spending

$728K

Total Claims

110

Beneficiaries

Avg Cost/Unit

$1382.15

Spending Trend

$9.0M(2019)→$9.7M(2020)→$9.8M(2021)→$7.4M(2022)→$2.1M(2023)→$728K(2024)

YoY Change:-43.2%

5yr CAGR:-12.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Alimta (2024)

Total Spending

$23.0M

Total Claims

57,657

Beneficiaries

13,143

ASP Price

$4.54

Spending Trend

$509.3M(2019)→$498.5M(2020)→$477.4M(2021)→$446.0M(2022)→$80.6M(2023)→$23.0M(2024)

YoY Change:-69.0%

5yr CAGR:-48.8%

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

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain12 active DMFs3 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

CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDInactivePEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE)

DMF 221412008

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