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Last Updated: May 1, 2024

Cladribine - Generic Drug Details

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What are the generic sources for cladribine and what is the scope of freedom to operate?

Cladribine is the generic ingredient in three branded drugs marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Mylan Labs Ltd, Janssen Pharms, and Emd Serono Inc, and is included in six NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cladribine has one hundred and fifty-one patent family members in thirty-five countries.

There are eight drug master file entries for cladribine. Four suppliers are listed for this compound.

Summary for cladribine

International Patents:	151
US Patents:	5
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	130
Patent Applications:	6,981
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for cladribine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cladribine
What excipients (inactive ingredients) are in cladribine?	cladribine excipients list
DailyMed Link:	cladribine at DailyMed

See drug prices for cladribine

Recent Clinical Trials for cladribine

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

Sponsor	Phase
University of Florida	Phase 2
Affiliated Hospital of Nantong University	N/A
Jining Medical University	Phase 2

See all cladribine clinical trials

Pharmacology for cladribine

Drug Class	Purine Antimetabolite

Medical Subject Heading (MeSH) Categories for cladribine

Antineoplastic Agents
Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for cladribine

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CLADRIBINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAVENCLAD	Tablets	cladribine	10 mg	022561	1	2022-04-07

US Patents and Regulatory Information for cladribine

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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
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	CLADRIBINE	cladribine	INJECTABLE;INJECTION	076571-001	Apr 22, 2004	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hisun Pharm Hangzhou	CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856-001	Nov 25, 2019	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Mylan Labs Ltd	CLADRIBINE	cladribine	INJECTABLE;INJECTION	200510-001	Oct 6, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cladribine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for cladribine

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Europe B.V.	Mavenclad	cladribine	EMEA/H/C/004230 Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.	Authorised	no	no	no	2017-08-22
Lipomed GmbH	Litak	cladribine	EMEA/H/C/000504 Litak is indicated for the treatment of hairy-cell leukaemia.	Authorised	no	no	no	2004-04-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for cladribine

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2805723		⤷ Try a Trial
Canada	3087419	SCHEMA POSOLOGIQUE A BASE DE CLADRIBINE DESTINE A TRAITER LA SCLEROSE EN PLAQUES (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS)	⤷ Try a Trial
Brazil	PI0408848	formulações orais de cladribine	⤷ Try a Trial
China	101912615	Cladribine formulations for improved oral and transmucosal delivery	⤷ Try a Trial
Cyprus	1119790		⤷ Try a Trial
Australia	2004226435	Cladribine formulations for improved oral and transmucosal delivery	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cladribine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805723	C20180006 00238	Estonia	⤷ Try a Trial	PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
2805723	PA2018503,C2805723	Lithuania	⤷ Try a Trial	PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344	C 2018 010	Romania	⤷ Try a Trial	PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822
1827461	132018000000141	Italy	⤷ Try a Trial	PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
2805723	324 6-2018	Slovakia	⤷ Try a Trial	PRODUCT NAME: KLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1608344	C20180007 00334	Estonia	⤷ Try a Trial	PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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