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Details for New Drug Application (NDA): 021318
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 seven 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: | 7 |
| 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 |
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: | ➤ Sign Up | Patent Expiration: | Dec 8, 2018 | Product Flag? | Y | 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: | ➤ Sign Up | 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: | ➤ Sign Up | Patent Expiration: | Dec 8, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | 021318-002 | Jun 25, 2008 | ➤ Sign Up | ➤ Sign Up |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ➤ Sign Up | ➤ Sign Up |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ➤ Sign Up | ➤ Sign Up |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ➤ Sign Up | ➤ Sign Up |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ➤ Sign Up | ➤ Sign Up |
| Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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