PEMETREXED DISODIUM Drug Patent Profile

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Pemetrexed Disodium is a drug marketed by Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Nang Kuang Pharm Co, Prinston Inc, Qilu Pharm Hainan, Waverley Pharma Inc, Zydus Pharms, and Sandoz. and is included in twenty-two NDAs.

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

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

US Patents:	0
Applicants:	18
NDAs:	22
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	109
Patent Applications:	4,660
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMETREXED DISODIUM
DailyMed Link:	PEMETREXED DISODIUM at DailyMed

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Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
Guangdong Association of Clinical Trials	Phase 3
Tianjin Medical University Cancer Institute and Hospital	Phase 2

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

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214073-001	May 25, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203628-001	Mar 10, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214218-002	Jun 22, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214408-002	Jul 19, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214657-003	May 26, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meitheal	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	215479-004	Dec 13, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nang Kuang Pharm Co	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	207352-001	May 25, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration