CRENESSITY Drug Patent Profile

Which patents cover Crenessity, and what generic alternatives are available?

Crenessity is a drug marketed by Neurocrine and is included in two NDAs. There are four patents protecting this drug.

This drug has one hundred and ten patent family members in twenty-nine countries.

The generic ingredient in CRENESSITY is crinecerfont. One supplier is listed for this compound. Additional details are available on the crinecerfont profile page.

DrugPatentWatch^® Generic Entry Outlook for Crenessity

Crenessity will be eligible for patent challenges on December 13, 2028. 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 December 13, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CRENESSITY

International Patents:	110
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	61
What excipients (inactive ingredients) are in CRENESSITY?	CRENESSITY excipients list
DailyMed Link:	CRENESSITY at DailyMed

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

Constraining patent/regulatory exclusivity:

ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)

NDA:

218808

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)

NDA:

218820

Dosage:

SOLUTION;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 CRENESSITY

CRENESSITY is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH).

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
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No				Y
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-003	Dec 13, 2024		RX	Yes	Yes
Neurocrine	CRENESSITY	crinecerfont	SOLUTION;ORAL	218820-001	Dec 13, 2024		RX	Yes	Yes
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-002	Dec 13, 2024		RX	Yes	No				Y

International Patents for CRENESSITY

See the table below for patents covering CRENESSITY around the world.

Country	Patent Number	Title	Estimated Expiration
China	106102740
European Patent Office	3890706
Israel	246783
Poland	3984523