Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Moodys
Merck
Boehringer Ingelheim
McKesson

Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Cladribine - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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, Mylan Labs Ltd, West-ward Pharms Int, Janssen Pharms, and Emd Serono Inc, and is included in five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cladribine has one hundred and twenty-four patent family members in thirty-three countries.

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

Drug Prices for cladribine

See drug prices for cladribine

Recent Clinical Trials for cladribine

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

SponsorPhase
Washington University School of MedicinePhase 4
Hematologics, IncPhase 2
University of Maryland, BaltimorePhase 2

See all cladribine clinical trials

Pharmacology for cladribine
Medical Subject Heading (MeSH) Categories for cladribine
Synonyms for cladribine
(2R,3S,5R)-5-(6-amino-2-chloro-9-purinyl)-2-(hydroxymethyl)-3-oxolanol
(2R,3S,5R)-5-(6-amino-2-chloro-9H-purin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
(2R,3S,5R)-5-(6-amino-2-chloro-9H-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol
(2R,3S,5R)-5-(6-amino-2-chloro-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol
(2R,3S,5R)-5-(6-Amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxalan-3-ol
(2R,3S,5R)-5-(6-amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
(2R,3S,5R)-5-(6-azanyl-2-chloranyl-purin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
2 Chlorodeoxyadenosine
2-CdA
2-chloro-2'-deoxy-adenosine
2-Chloro-2'-deoxy-beta-adenosine
2-Chloro-2'-deoxyadenosine
2-Chloro-2'-deoxyadenosine, antileukemic
2-chloro-6-amino-9-(2-deoxy-beta-D-erythro-pentofuranosyl)purine
2-Chloro-6-amino-9-(2-deoxy-beta-D-erythropentofuranosyl)purine
2-chloro-deoxyadenosine
2-Chlorodeoxyadenosine
24757-90-2
291C638
2CdA
2ClAdo
4291-63-8
47M74X9YT5
6-amino-2-chloro-9-(2-deoxy-beta-D-erythro-pentofuranosyl)purine
6-amino-2-chloro-9-(2-deoxy-beta-erythropentofuranosyl)purine
A826062
AB0011806
AB00382963_19
AB00382963-17
AC-7591
AC1L2FXP
ACT02615
Adenosine, 2-chloro-2'-deoxy
ADENOSINE, 2-CHLORO-2'-DEOXY-
AJ-45639
AK-46529
AKOS015854898
AKOS015892544
AS-12366
AX8000129
BCP02868
BCP9000538
BDBM38920
BR-46529
BRN 0624220
C-17986
C10H12ClN5O3.C3H8
CAS-4291-63-8
CC-25898
CC0168
CCG-101116
CCRIS 9374
CHEBI:567361
CHEMBL1619
Chlorodeoxyadenosine
cid_20279
CJ-10765
CL9
Cladarabine
Cladaribine
Cladiribine
cladribina
Cladribine (JAN/USAN/INN)
Cladribine [USAN:INN:BAN]
Cladribine [USAN:USP:INN:BAN]
Cladribine for peak identification, European Pharmacopoeia (EP) Reference Standard
Cladribine, European Pharmacopoeia (EP) Reference Standard
Cladribine, United States Pharmacopeia (USP) Reference Standard
cladribinum
CldAdo
CPD000058553
CS-2057
CTK8D4033
D01370
DB00242
DSSTox_CID_2828
DSSTox_GSID_22828
DSSTox_RID_76747
DTXSID8022828
FT-0080707
GTPL4799
HMS2052K13
HMS2232C23
HMS3715F17
HSDB 7564
HY-13599
KB-22050
Leustat
Leustatin
Leustatin (TN)
Leustatin|||2-Chloro-2'-deoxyadenosine|||2-CdA|||NSC-105014-F|||(2R,3S,5R)-5-(6-Amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
Litak
LS-15109
mavenclad
MFCD00153939
MLS000028377
MLS000028484
MLS000759397
MLS001077345
MLS001424194
MolPort-005-935-074
Movectro
Mylinax
NC00366
NCGC00018167-03
NCGC00022567-05
NCGC00022567-06
NCGC00022567-07
NCGC00022567-08
NCGC00164384-01
NCGC00254518-01
NSC 105014
NSC 105014-F
NSC-105014
Opera_ID_1191
PTOAARAWEBMLNO-KVQBGUIXSA-N
RTC-063884
RWJ 26251
RWJ-26251
RWJ-26251-000
S-7479
S1199
SAM001246526
SC-17356
SCHEMBL3775
SMR000058553
SR-01000003063
SR-01000003063-10
SR-01000003063-7
ST2409775
SW197746-4
TC-063884
Tox21_110834
Tox21_300596
UNII-47M74X9YT5
ZINC3798064

US Patents and Regulatory Information for cladribine

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   Start Trial   Start Trial   Start Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cladribine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2805723 PA2018503 Lithuania   Start Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461 1890010-0 Sweden   Start Trial PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
1827461 122018000021 Germany   Start Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Medtronic
Moodys
Baxter
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.