DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 208743
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 3.12MG/1.56ML (2MG/ML) | ||||
Approval Date: | Apr 28, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 28, 2022 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | Start Trial | Patent Expiration: | Mar 26, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE. | ||||||||
Patent: | Start Trial | Patent Expiration: | Nov 8, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Complete Access Available with Subscription