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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.
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 |
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 |
Paragraph IV (Patent) Challenges for 021318
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FORTEO | INJECTABLE;SUBCUTANEOUS | teriparatide recombinant human | 021318 | 2015-07-27 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 0.75MG/3ML (0.25MG/ML) | ||||
| Approval Date: | Nov 26, 2002 | TE: | RLD: | No | |||||
| Patent: | Start Trial | Patent Expiration: | Aug 19, 2019 | Product 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: | Start Trial | Patent Expiration: | Aug 19, 2019 | Product 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: | Start Trial | Patent Expiration: | Aug 19, 2019 | Product 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 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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