Pemetrexed disodium - Generic Drug Details

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What are the generic drug sources for pemetrexed disodium and what is the scope of patent protection?

Pemetrexed disodium is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. 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 eighteen patent family members in eleven countries.

There are twenty-nine drug master file entries for pemetrexed disodium. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for pemetrexed disodium

International Patents:	18
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	29
Suppliers / Packagers:	1
Bulk Api Vendors:	126
Clinical Trials:	95
Patent Applications:	7,346
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pemetrexed disodium
DailyMed Link:	pemetrexed disodium at DailyMed

Recent Clinical Trials for pemetrexed disodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NRG Oncology	Phase 3
BeiGene	Phase 3
Merck Sharp & Dohme Corp.	Phase 2

See all pemetrexed disodium clinical trials

Generic filers with tentative approvals for PEMETREXED DISODIUM

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	500MG	INJECTABLE;INJECTION
Start Trial	Start Trial	100MG	INJECTABLE;INJECTION
Start Trial	Start Trial	100MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pemetrexed disodium

Drug Class	Folate Analog Metabolic Inhibitor
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

Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALIMTA	POWDER;INTRAVENOUS	pemetrexed disodium	021462	2016-10-06
ALIMTA	POWDER;INTRAVENOUS	pemetrexed disodium	021462	2012-06-27
ALIMTA	POWDER;INTRAVENOUS	pemetrexed disodium	021462	2008-07-01
ALIMTA	POWDER;INTRAVENOUS	pemetrexed disodium	021462	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
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
>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	Start Trial	Start Trial
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	Start Trial	Start Trial
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	Start Trial	Start Trial
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for pemetrexed disodium

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Country	Patent Number	Estimated Expiration
Slovenia	1313508	Start Trial
Japan	2018197265	Start Trial
Japan	2014005304	Start Trial
World Intellectual Property Organization (WIPO)	0202093	Start Trial
Austria	359823	Start Trial
Denmark	1313508	Start Trial
Cyprus	1107649	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for pemetrexed disodium

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

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