Details for New Drug Application (NDA): 216490
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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: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) | ||||
Approval Date: | Aug 9, 2024 | TE: | 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 Up | Patent Expiration: | Sep 28, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF HYPOPARATHYROIDISM IN ADULTS |
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