Paltusotine hydrochloride - Generic Drug Details

What are the generic sources for paltusotine hydrochloride and what is the scope of patent protection?

Paltusotine hydrochloride is the generic ingredient in one branded drug marketed by Crinetics and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Paltusotine hydrochloride has one hundred and ten patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for paltusotine hydrochloride

International Patents:	110
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
Patent Applications:	29
DailyMed Link:	paltusotine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for paltusotine hydrochloride

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

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.

Recent Clinical Trials for paltusotine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Crinetics Pharmaceuticals Inc.	PHASE3
Crinetics Pharmaceuticals Inc.	Phase 3
Crinetics Pharmaceuticals Inc.	Phase 2

See all paltusotine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for paltusotine hydrochloride

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for paltusotine hydrochloride

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	219070-002	Sep 25, 2025		RX	Yes	Yes
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-002	Sep 25, 2025		RX	Yes	Yes	11,266,641		Y
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No	10,875,839
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-002	Sep 25, 2025		RX	Yes	Yes
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No	11,957,674
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-002	Sep 25, 2025		RX	Yes	Yes	10,597,377		Y	Y
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No

International Patents for paltusotine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2017296392
Australia	2020277122
Brazil	112019000692
Canada	3030423
China	109715612
China	115557929
Denmark	3484865