Details for New Drug Application (NDA): 021318

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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. Six 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) / 2.24 mL in 1 SYRINGE
FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318	NDA	Eli Lilly and Company	0002-9678	0002-9678-01	1 SYRINGE in 1 CARTON (0002-9678-01) / 2.24 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	0.75MG/3ML (0.25MG/ML)
Approval Date:	Nov 26, 2002	TE:		RLD:	No
Patent:	7,517,334	Patent Expiration:	Mar 25, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	0.56MG/2.24ML (0.25MG/ML)
Approval Date:	Jun 25, 2008	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021318

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,144,861	⤷ Get Started Free
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,550,434	⤷ Get Started Free
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	7,351,414	⤷ Get Started Free
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	6,977,077	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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