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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 216490


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NDA 216490 describes YORVIPATH, which is a drug marketed by Ascendis Pharma Bone and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the YORVIPATH profile page.

The generic ingredient in YORVIPATH is palopegteriparatide. One supplier is listed for this compound. Additional details are available on the palopegteriparatide profile page.
Summary for 216490
Tradename:YORVIPATH
Applicant:Ascendis Pharma Bone
Ingredient:palopegteriparatide
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216490
Generic Entry Date for 216490*:
Constraining patent/regulatory exclusivity:
TREATMENT OF HYPOPARATHYROIDISM IN ADULTS
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: 216490
Suppliers and Packaging for NDA: 216490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YORVIPATH palopegteriparatide SOLUTION;SUBCUTANEOUS 216490 NDA Ascendis Pharma, Endocrinology, Inc. 73362-100 73362-100-01 2 BOX in 1 CARTON (73362-100-01) / 1 SYRINGE in 1 BOX (73362-100-02) / 1 CARTRIDGE in 1 SYRINGE (73362-100-03) / .56 mL in 1 CARTRIDGE
YORVIPATH palopegteriparatide SOLUTION;SUBCUTANEOUS 216490 NDA Ascendis Pharma, Endocrinology, Inc. 73362-101 73362-101-01 2 BOX in 1 CARTON (73362-101-01) / 1 SYRINGE in 1 BOX (73362-101-02) / 1 CARTRIDGE in 1 SYRINGE (73362-101-03) / .98 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)
Approval Date:Aug 9, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 9, 2027
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Aug 9, 2031
Regulatory Exclusivity Use:TREATMENT OF HYPOPARATHYROIDISM IN ADULTS
Patent:⤷  Sign UpPatent Expiration:Sep 28, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPOPARATHYROIDISM IN ADULTS

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