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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 |
Generic Entry Opportunity Date for 021318
Generic Entry Date for 021318*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021318
| Ingredient-type | Parathyroid Hormone |
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: | ➤ Try a Free Trial | 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: | ➤ Try a Free 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: | ➤ Try a Free Trial | Patent Expiration: | Dec 8, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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