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ALIMTA Drug Profile

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Alimta is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for Tradename: ALIMTA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: ALIMTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYes5,344,932*PED► subscribeY► subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004RXYes5,344,932*PED► subscribeY► subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYes7,772,209*PED► subscribeY► subscribe
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Expired Patents for Tradename: ALIMTA

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
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Paragraph IV activity for: ALIMTA

Drugname Dosage Strength RLD Submissiondate
pemetrexed disodiumFor Injection750 mg/vialAlimta10/6/2016
pemetrexed disodiumFor Injection1000 mg/vialAlimta6/27/2012
pemetrexed disodiumFor Injection100 mg/vialAlimta7/1/2008
pemetrexed disodiumFor Injection500 mg/vialAlimta2/4/2008

Non-Orange Book Patents for Tradename: ALIMTA

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
4,996,206 N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives► subscribe
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
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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 Tradename: ALIMTA

Country Document Number Estimated Expiration
Netherlands300181► subscribe
South Africa9009631► subscribe
Denmark0432677► 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: ALIMTA

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
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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