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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Merck
Harvard Business School
Healthtrust
US Department of Justice
Queensland Health
Cantor Fitzgerald
McKinsey
Daiichi Sankyo

Generated: November 20, 2017

DrugPatentWatch Database Preview

Alimta Drug Profile

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What is the patent landscape for Alimta, and when can generic versions of Alimta launch?

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

This drug has thirty-one patent family members in twenty-five countries and six supplementary protection certificates in six countries.

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed disodium profile page.
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
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004RXYesYes► Subscribe► 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)021462-002Sep 7, 2007► Subscribe► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004► Subscribe► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004► Subscribe► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 2007► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Argentina245129► Subscribe
Ireland904445► Subscribe
Austria135007► Subscribe
Hungary908147► Subscribe
Cyprus2076► Subscribe
New Zealand236385► Subscribe
Singapore48098► Subscribe
Netherlands300181► Subscribe
Australia6779190► Subscribe
Canada2031890► 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
0432677/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0181Netherlands► Subscribe300181, 20101210, EXPIRES: 20151209
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
147Luxembourg► Subscribe91147, EXPIRES: 20151210
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Serving leading biopharmaceutical companies globally:

Novartis
AstraZeneca
Fish and Richardson
US Department of Justice
Baxter
Accenture
Queensland Health
Chubb
Express Scripts
US Army

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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