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Generated: September 22, 2019

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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 one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTEO profile page.

The generic ingredient in FORTEO is teriparatide recombinant human. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the teriparatide recombinant human profile page.
Summary for 021318
Tradename:FORTEO
Applicant:Lilly
Ingredient:teriparatide recombinant human
Patents:4
Formulation / Manufacturing:see details
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 recombinant human INJECTABLE;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 recombinant human INJECTABLE;SUBCUTANEOUS 021318 NDA Eli Lilly and Company 0002-8400 0002-8400-99 1 SYRINGE in 1 CARTON (0002-8400-99) > 2.4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength0.75MG/3ML (0.25MG/ML)
Approval Date:Nov 26, 2002TE:RLD:No
Patent:  Try a Free TrialPatent Expiration:Aug 19, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE
Patent:  Try a Free TrialPatent Expiration:Aug 19, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE RELATED TO OSTEOPOROSIS
Patent:  Try a Free TrialPatent Expiration:Aug 19, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE

Expired US Patents for NDA 021318

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

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