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Pemetrexed disodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pemetrexed disodium?

Pemetrexed disodium is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty patent family members in twenty-five countries.

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

Summary for Generic Name: pemetrexed disodium

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list25
Suppliers / Packagers: see list1
Bulk Api Vendors: see list59
Clinical Trials: see list207
Patent Applications: see list2,129
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pemetrexed disodium at DailyMed

Pharmacology for Ingredient: pemetrexed disodium

Tentative approvals for PEMETREXED DISODIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE;INJECTION100MG
► Subscribe► SubscribeINJECTABLE;INJECTION500MG
► Subscribe► SubscribeINJECTABLE;INJECTION100MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004RXYesYes5,344,932*PED► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYesYes7,772,209*PED► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004RXYesYes7,772,209*PED► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYesYes5,344,932*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pemetrexed disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 20045,217,974*PED► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 20075,217,974*PED► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 20075,344,932*PED► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 20045,344,932*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pemetrexed disodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,248,775 Pyrrolo(2,3-d)pyrimidines► Subscribe
5,028,608 N-(6-Amino-(pyrrolo(2,3-d)pyrimidin-3-ylacyl) )-glutamic acid derivatives► Subscribe
4,996,206 N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pemetrexed disodium

Country Document Number Estimated Expiration
China1055182► Subscribe
Israel96531► Subscribe
Portugal96140► Subscribe
Singapore48098► Subscribe
Greece3019784► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PEMETREXED DISODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005Austria► SubscribePRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0181Netherlands► Subscribe300181, 20101210, EXPIRES: 20151209
2005 00008Denmark► Subscribe
C/GB05/011United Kingdom► SubscribePRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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