REZLIDHIA Drug Patent Profile

When do Rezlidhia patents expire, and when can generic versions of Rezlidhia launch?

Rezlidhia is a drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this drug.

The generic ingredient in REZLIDHIA is olutasidenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the olutasidenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Rezlidhia

Rezlidhia will be eligible for patent challenges on December 1, 2026. 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 May 16, 2039. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for REZLIDHIA

US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	85
Drug Prices:	Drug price information for REZLIDHIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REZLIDHIA
What excipients (inactive ingredients) are in REZLIDHIA?	REZLIDHIA excipients list
DailyMed Link:	REZLIDHIA at DailyMed

See drug prices for REZLIDHIA

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

NDA:

215814

Dosage:

CAPSULE;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 REZLIDHIA

REZLIDHIA is protected by fourteen US patents and two FDA Regulatory Exclusivities.

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
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes			Y	Y
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes

International Patents for REZLIDHIA

When does loss-of-exclusivity occur for REZLIDHIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Denmark

European Patent Office

Finland

Hungary

Lithuania

Moldova, Republic of

Morocco

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REZLIDHIA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	101976
Australia	2015317322
Australia	2015317327