.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021462

« Back to Dashboard
NDA 021462 describes ALIMTA, which 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. Additional details are available on the ALIMTA profile page.

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 three tentative approvals for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for NDA: 021462

Tradename:
ALIMTA
Applicant:
Lilly
Ingredient:
pemetrexed disodium
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021462

Suppliers and Packaging for NDA: 021462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION) 021462 NDA Eli Lilly and Company 0002-7623 0002-7623-01 1 VIAL in 1 CARTON (0002-7623-01) > 20 mL in 1 VIAL
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION) 021462 NDA Eli Lilly and Company 0002-7640 0002-7640-01 1 VIAL in 1 CARTON (0002-7640-01) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 500MG BASE/VIAL
Approval Date:Feb 4, 2004TE:RLD:Yes
Patent:5,344,932*PEDPatent Expiration:Jan 24, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:7,772,209*PEDPatent Expiration:May 24, 2022Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Oct 17, 2015
Regulatory Exclusivity Use:LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL

Expired Orange Book Patents for NDA: 021462

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 20075,217,974*PED► subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 20045,217,974*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc