Cladribine - Generic Drug Details

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What are the generic drug 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-three 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:	153
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:	133
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
Institute of Hematology & Blood Diseases Hospital, China	Phase 2
University of Florida	Phase 2
The First Affiliated Hospital of Soochow University	N/A

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
Mylan Labs Ltd	CLADRIBINE	cladribine	INJECTABLE;INJECTION	200510-001	Oct 6, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Fresenius Kabi Usa	CLADRIBINE	cladribine	INJECTABLE;INJECTION	076571-001	Apr 22, 2004	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hisun Pharm Hangzhou	CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856-001	Nov 25, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	LEUSTATIN	cladribine	INJECTABLE;INJECTION	020229-001	Feb 26, 1993		DISCN	Yes	No	⤷ 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

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	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	⤷ Sign Up	⤷ Sign Up
>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
South Africa	200507935	Cladribine formulations for improved oral and transmucosal delivery	⤷ Sign Up
Croatia	P20050924	CLADRIBINE FORMULATIONS FOR IMPROVED ORAL AND TRANSMUCOSAL DELIVERY	⤷ Sign Up
Norway	20054945		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004087101		⤷ Sign Up
Lithuania	PA2018502		⤷ Sign Up
Russian Federation	2005133196	ПЕРОРАЛЬНЫЕ ПРЕПАРАТИВНЫЕ ФОРМЫ КЛАДРИБИНА	⤷ Sign Up
Singapore	11202004772R	CLADRIBINE REGIMEN FOR USE INTREATING PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS	⤷ Sign Up
>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
1608344	PA2018502,C1608344	Lithuania	⤷ Sign Up	PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461	132018000000141	Italy	⤷ Sign Up	PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
1827461	2018C/010	Belgium	⤷ Sign Up	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
2805723	C20180006 00238	Estonia	⤷ Sign Up	PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
1827461	9/2018	Austria	⤷ Sign Up	PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1608344	372 4-2018	Slovakia	⤷ Sign Up	PRODUCT NAME: KLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1827461	122018000021	Germany	⤷ Sign Up	PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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