Details for New Drug Application (NDA): 208743
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NDA 208743 describes TYMLOS, which is a drug marketed by Radius and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the TYMLOS profile page.
The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this compound. Additional details are available on the abaloparatide profile page.
The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this compound. Additional details are available on the abaloparatide profile page.
Summary for 208743
| Tradename: | TYMLOS |
| Applicant: | Radius |
| Ingredient: | abaloparatide |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208743
Generic Entry Date for 208743*:
Constraining patent/regulatory exclusivity:
TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY Dosage:
SOLUTION;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: 208743
Suppliers and Packaging for NDA: 208743
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | NDA | Radius Health, Inc. | 70539-001 | 70539-001-02 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01) |
| TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | NDA | Radius Health, Inc. | 70539-001 | 70539-001-98 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 3.12MG/1.56ML (2MG/ML) | ||||
| Approval Date: | Apr 28, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 19, 2025 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 30, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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