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LITFULO Drug Patent Profile

When do Litfulo patents expire, and what generic alternatives are available?

Litfulo is a drug marketed by Pfizer and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-four patent family members in forty-four countries.

The generic ingredient in LITFULO is ritlecitinib tosylate. Two suppliers are listed for this compound. Additional details are available on the ritlecitinib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Litfulo

Litfulo will be eligible for patent challenges on June 23, 2027. 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 June 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LITFULO

International Patents:	64
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for LITFULO
What excipients (inactive ingredients) are in LITFULO?	LITFULO excipients list
DailyMed Link:	LITFULO at DailyMed

See drug prices for LITFULO

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215830

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.

Pharmacology for LITFULO

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors Janus Kinase 3 Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LITFULO

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for LITFULO

LITFULO is protected by one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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

Patents protecting LITFULO

FDA Regulatory Exclusivity protecting LITFULO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes			Y	Y
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes

International Patents for LITFULO

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

Country	Patent Number	Title	Estimated Expiration
China	107417684	杂环丙烯酰胺 (Heterocyclic acrylamide)
Spain	2654051
Moldova, Republic of	4649	Pirol[2,3-d]pirimidinil, pirol[2,3-b]pirazinil şi pirol[2,3-d]piridinil acrilamide (Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides)
Croatia	P20171846
Hungary	E054560

Supplementary Protection Certificates for LITFULO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3077395	CA 2023 00028	Denmark		PRODUCT NAME: RITLECITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1755 20230915
3077395	LUC00322	Luxembourg		PRODUCT NAME: RITLECITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1755 20230918
3077395	301245	Netherlands		PRODUCT NAME: RITLECITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1755 20230918