PEMETREXED DISODIUM - Generic Drug Details

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What are the generic sources for pemetrexed disodium and what is the scope of freedom to operate?

Pemetrexed disodium is the generic ingredient in three branded drugs marketed by Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-five NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pemetrexed disodium has one patent family member in one country.

There are twenty-two drug master file entries for pemetrexed disodium. Twenty-two suppliers are listed for this compound.

Summary for PEMETREXED DISODIUM

International Patents:	1
US Patents:	1
Tradenames:	3
Applicants:	21
NDAs:	25
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	109
Patent Applications:	6,806
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMETREXED DISODIUM
What excipients (inactive ingredients) are in PEMETREXED DISODIUM?	PEMETREXED DISODIUM excipients list
DailyMed Link:	PEMETREXED DISODIUM at DailyMed

Recent Clinical Trials for PEMETREXED DISODIUM

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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

See all PEMETREXED DISODIUM clinical trials

Pharmacology for PEMETREXED DISODIUM

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

Medical Subject Heading (MeSH) Categories for PEMETREXED DISODIUM

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PEMETREXED DISODIUM

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

Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM

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 PEMETREXED DISODIUM

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Glossary

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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
Apotex	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	209851-001	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214073-002	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203628-001	Mar 10, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PEMETREXED DISODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	⤷ Sign Up	⤷ Sign Up
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	⤷ Sign Up	⤷ Sign Up
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PEMETREXED DISODIUM

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016151365		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PEMETREXED DISODIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	7/2005	Austria	⤷ Sign Up	PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	SPC/GB05/011	United Kingdom	⤷ Sign Up	PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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