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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 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. Two suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Two 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 |
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 | 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 | SOLUTION;SUBCUTANEOUS | teriparatide | 021318 | 2015-07-27 |
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: | Start Trial | 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 | 0.6MG/2.4ML (0.25MG/ML) | ||||
| Approval Date: | Jun 25, 2008 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 25, 2025 | 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 | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | Start Trial | Start Trial |
| Lilly | FORTEO | teriparatide | SOLUTION;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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