LEQSELVI Drug Patent Profile

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

Leqselvi is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in LEQSELVI is deuruxolitinib phosphate. Additional details are available on the deuruxolitinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Leqselvi

Leqselvi will be eligible for patent challenges on July 25, 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 July 25, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LEQSELVI

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
DailyMed Link:	LEQSELVI at DailyMed

Drug patent expirations by year for LEQSELVI

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

Generic Entry Date for LEQSELVI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217900 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 LEQSELVI

LEQSELVI is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEQSELVI is ⤷ Sign Up.

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 LEQSELVI

Treatment of hair loss disorders with deuterated JAK inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA

FDA Regulatory Exclusivity protecting LEQSELVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 LEQSELVI

When does loss-of-exclusivity occur for LEQSELVI?

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

Australia

Patent: 17261286
Patent: Treatment of hair loss disorders with deuterated JAK inhibitors
Estimated Expiration: ⤷ Sign Up

Patent: 23201112
Patent: Treatment of hair loss disorders with deuterated JAK inhibitors
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2018072339
Patent: tratamento de distúrbios de perda de cabelo com inibidores de jak deuterados
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 22519
Patent: TRAITEMENT DES TROUBLES DE LA CHUTE DES CHEVEUX PAR DES INHIBITEURS DE JAK DEUTERES (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 9069493
Patent: 用氘代JAK抑制剂治疗脱毛障碍 (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 1892360
Patent: ЛЕЧЕНИЕ НАРУШЕНИЙ, ХАРАКТЕРИЗУЮЩИХСЯ ВЫПАДЕНИЕМ ВОЛОС, С ПОМОЩЬЮ ДЕЙТЕРИРОВАННЫХ ИНГИБИТОРОВ JAK
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 52039
Patent: TRAITEMENT DES TROUBLES DE LA CHUTE DES CHEVEUX PAR DES INHIBITEURS DE JAK DEUTÉRÉS (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Estimated Expiration: ⤷ Sign Up

Patent: 24367
Patent: TRAITEMENT DES TROUBLES DE LA CHUTE DES CHEVEUX PAR DES INHIBITEURS DE JAK DEUTÉRÉS (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 45080
Estimated Expiration: ⤷ Sign Up

Patent: 19516684
Patent: 重水素化ＪＡＫ阻害剤による脱毛障害の処置
Estimated Expiration: ⤷ Sign Up

Patent: 22171838
Patent: 重水素化ＪＡＫ阻害剤による脱毛障害の処置
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 18013347
Patent: TRATAMIENTO DE TRASTORNOS DE PÉRDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

Patent: 21014175
Patent: TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

Patent: 23002321
Patent: TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

Patent: 23002323
Patent: TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

Patent: 23002324
Patent: TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

Patent: 23002325
Patent: TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 190003711
Patent: 중수소화된 JAK 저해제를 이용한 탈모 장애의 치료
Estimated Expiration: ⤷ Sign Up

Patent: 230086814
Patent: 중수소화된 JAK 저해제를 이용한 탈모 장애의 치료 (JAK TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Estimated Expiration: ⤷ Sign Up

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 LEQSELVI around the world.

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Country	Patent Number	Title	Estimated Expiration
Mexico	2021014175	TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)	⤷ Sign Up
Mexico	2023002325	TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)	⤷ Sign Up
Mexico	2018013347	TRATAMIENTO DE TRASTORNOS DE PÉRDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration