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Last Updated: May 30, 2020

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HYCAMTIN Drug Profile


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Which patents cover Hycamtin, and when can generic versions of Hycamtin launch?

Hycamtin is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Hycamtin

A generic version of HYCAMTIN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.

  Start Trial

Drug patent expirations by year for HYCAMTIN
Drug Prices for HYCAMTIN

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Recent Clinical Trials for HYCAMTIN

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
Children's Oncology GroupPhase 3
Michael Vogelbaum, MD, PhDEarly Phase 1

See all HYCAMTIN clinical trials

Pharmacology for HYCAMTIN
Synonyms for HYCAMTIN
(19S)-8-[(dimethylamino)methyl]-19-ethyl-7,19-dihydroxy-17-oxa-3,13-diazapentacyclo[11.8.0.0(2),(1)(1).0?,?.0(1)?,(2)?]henicosa-1(21),2,4,6,8,10,15(20)-heptaene-14,18-dione hydrochloride
(S)-10-((Dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4H,12H)-dione monohydrochloride
(S)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1H-pyrano[3,4:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride
(S)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride
(S)-10-[(Dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-Pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione Hydrochloride
(S)-10-[(Dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[l,2-b]quinoline-3,14(4H,12H)-dione monohydrochloride
10-[(Dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride
119413-54-6
1H-Pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4H,12H)-dione, 10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-, monohydrochloride, (S)-
1H-Pyrano[3',7]indolizino[1,2-b]quinoline- 3,14(4H,12H)-dione, 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-, monohydrochloride, (4S)-
413T546
9-Dimethylaminomethyl-10-hydroxycamptothecin, HCl salt
9-Dimethylaminomethyl-10-hydroxycamptothecin.
956S425ZCY
AB0012839
AC-1551
AK-48920
AKOS015900415
AOB6645
AX8001571
BCP00930
BG0599
BR-48920
C-22572
C23H23N3O5.HCl
CAS-119413-54-6
CCG-37460
CHEMBL1607
CPD000466344
CS-1498
CT0202
D02168
DGHHQBMTXTWTJV-BQAIUKQQSA-N
DRG-0288
DSSTox_CID_25952
DSSTox_GSID_45952
DSSTox_RID_81248
DTXSID1045952
E-89/001
Evotropin
FT-0631095
HMS1922H22
HY-13768A
Hycamptamine hydrochloride
Hycamtin (TN)
Hycamtin (TN) (GlaxoSmith)
KS-00000HA7
KS-1410
LS-172415
MLS000759456
MLS001401447
NC00177
NCGC00014925
NCGC00014925-06
NCGC00095189-01
NCGC00095189-02
NCGC00095189-03
NCI609699
NK-211
nogitecan HCl
Nogitecan hydrochloride
Nogitecan hydrochloride (JAN)
NSC 609699
NSC-609699
NSC-759263
NSC609699
NSC759263
Pharmakon1600-01505820
Potactasol (TN)
Q27271753
S-5061
s1231
SAM001246651
SCHEMBL7247
SK&F 104864-A
SK&F S-104864-A
SK&F-S-104864-A
SK&F-S-104864A
SKF 104864A
SKF-S 104864-A
SKFS 104864A
SMR000466344
SPECTRUM1505820
SW197557-5
T-160
Topotecan (Hydrochloride)
Topotecan Hcl
Topotecan HCl - Hycamtin
TOPOTECAN HYDROCHLORIDE
Topotecan hydrochloride (USAN)
Topotecan hydrochloride [USAN]
Topotecan monohydrochloride
Tox21_111478
Tox21_111478_1
UNII-956S425ZCY

US Patents and Regulatory Information for HYCAMTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 AP RX Yes 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

Expired US Patents for HYCAMTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996   Start Trial   Start Trial
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007   Start Trial   Start Trial
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996   Start Trial   Start Trial
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for HYCAMTIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0321122 C970017 Netherlands   Start Trial PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016
0321122 97C0009 Belgium   Start Trial PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
0321122 SPC/GB96/057 United Kingdom   Start Trial PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0321122 2/1997 Austria   Start Trial PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Boehringer Ingelheim
McKinsey
Dow
Mallinckrodt

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 verification 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.