Details for New Drug Application (NDA): 219070
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NDA 219070 describes PALSONIFY, which is a drug marketed by Crinetics 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 PALSONIFY profile page.
The generic ingredient in PALSONIFY is paltusotine hydrochloride. One supplier is listed for this compound. Additional details are available on the paltusotine hydrochloride profile page.
The generic ingredient in PALSONIFY is paltusotine hydrochloride. One supplier is listed for this compound. Additional details are available on the paltusotine hydrochloride profile page.
Summary for 219070
| Tradename: | PALSONIFY |
| Applicant: | Crinetics |
| Ingredient: | paltusotine hydrochloride |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219070
Generic Entry Date for 219070*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*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.
Suppliers and Packaging for NDA: 219070
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070 | NDA | Crinetics Pharmaceuticals, Inc. | 84015-920 | 84015-920-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60) |
| PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070 | NDA | Crinetics Pharmaceuticals, Inc. | 84015-930 | 84015-930-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84015-930-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 25, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 25, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 12, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 16, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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