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Last Updated: March 29, 2024

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 eight 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.
Summary for 208743
Tradename:TYMLOS
Applicant:Radius
Ingredient:abaloparatide
Patents:8
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:RXDosage:SOLUTION;SUBCUTANEOUSStrength3.12MG/1.56ML (2MG/ML)
Approval Date:Apr 28, 2017TE: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:⤷  Try a TrialPatent Expiration:Apr 30, 2038Product Flag?YSubstance Flag?Delist Request?

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