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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208743

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NDA 208743 describes TYMLOS, which is a drug marketed by Radius Health Inc and is included in one NDA. It is available from one supplier. There are three 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 Health Inc
Ingredient:abaloparatide
Patents:3
Generic Entry Opportunity Date for 208743
Generic Entry Date for 208743*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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:Apr 28, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Mar 26, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Patent:➤ Try a Free TrialPatent Expiration:Nov 8, 2027Product Flag?YSubstance Flag?Delist Request?

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