PALSONIFY Drug Patent Profile
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Which patents cover Palsonify, and when can generic versions of Palsonify launch?
Palsonify is a drug marketed by Crinetics and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and ten patent family members in thirty-four countries.
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.
DrugPatentWatch® Generic Entry Outlook for Palsonify
Palsonify will be eligible for patent challenges on September 25, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 25, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
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Summary for PALSONIFY
| International Patents: | 110 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in PALSONIFY? | PALSONIFY excipients list |
| DailyMed Link: | PALSONIFY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PALSONIFY
Generic Entry Date for PALSONIFY*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION NDA:
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.
US Patents and Regulatory Information for PALSONIFY
PALSONIFY is protected by nine US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PALSONIFY is ⤷ Start Trial.
This potential generic entry date is based on TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070-001 | Sep 25, 2025 | RX | Yes | No | 12,208,092 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070-002 | Sep 25, 2025 | RX | Yes | Yes | 10,351,547 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070-001 | Sep 25, 2025 | RX | Yes | No | 10,351,547 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070-001 | Sep 25, 2025 | RX | Yes | No | 11,266,641 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for PALSONIFY
See the table below for patents covering PALSONIFY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2017296392 | ⤷ Start Trial | |
| Australia | 2020277122 | ⤷ Start Trial | |
| Brazil | 112019000692 | ⤷ Start Trial | |
| Canada | 3030423 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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