You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 021318


✉ Email this page to a colleague

« Back to Dashboard


NDA 021318 describes FORTEO, which is a drug marketed by Lilly and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTEO profile page.

The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
Summary for 021318
Tradename:FORTEO
Applicant:Lilly
Ingredient:teriparatide
Patents:1
Pharmacology for NDA: 021318
Suppliers and Packaging for NDA: 021318
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318 NDA Eli Lilly and Company 0002-8400 0002-8400-01 1 SYRINGE in 1 CARTON (0002-8400-01) / 2.4 mL in 1 SYRINGE
FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-495 66993-495-28 1 SYRINGE in 1 CARTON (66993-495-28) / 2.4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;SUBCUTANEOUSStrength0.75MG/3ML (0.25MG/ML)
Approval Date:Nov 26, 2002TE:RLD:No
Patent:⤷  Try a TrialPatent Expiration:Mar 25, 2025Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength0.6MG/2.4ML (0.25MG/ML)
Approval Date:Jun 25, 2008TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 25, 2025Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021318

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.