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 nine 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.
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: | 9 |
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, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 9, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HYPOPARATHYROIDISM IN ADULTS | ||||||||
| Patent: | 11,590,207 | Patent Expiration: | Sep 28, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPOPARATHYROIDISM IN ADULTS | ||||||||
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