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Last Updated: February 23, 2020

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COPIKTRA Drug Profile


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

Copiktra is a drug marketed by Verastem Inc and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-three patent family members in thirty-one countries.

The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.

US ANDA Litigation and Generic Entry Outlook for Copiktra

Copiktra will be eligible for patent challenges on September 24, 2022. 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 September 24, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COPIKTRA
International Patents:133
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 56
Clinical Trials: 1
Patent Applications: 114
DailyMed Link:COPIKTRA at DailyMed
Drug patent expirations by year for COPIKTRA
Generic Entry Opportunity Date for COPIKTRA
Generic Entry Date for COPIKTRA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES
NDA:
Dosage:
CAPSULE;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.

Recent Clinical Trials for COPIKTRA

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

SponsorPhase
Verastem, Inc.Phase 1/Phase 2

See all COPIKTRA clinical trials

Synonyms for COPIKTRA
(S)-3-(1-((9H-Purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
(S)-3-(1-(7H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
1(2H)-Isoquinolinone, 8-chloro-2-phenyl-3-((1S)-1-(9H-purin-6-ylamino)ethyl)-
1(2H)-Isoquinolinone, 8-chloro-2-phenyl-3-((1S)-1-(9H-purin-6-ylamino)ethyl)-, hydrate
1(2H)-Isoquinolinone, 8-chloro-2-phenyl-3-((1S)-1-(9H-purin-6-ylamino)ethyl)-, hydrate (1:1)
1(2H)-Isoquinolinone, 8-chloro-2-phenyl-3-[(1S)-1-(9H-purin-6-ylamino)ethyl]-
1201438-56-3
1386861-49-9
4WD61MR063
610V23S0JI
8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one
A12422
AB0032504
AC-30239
AJ-128213
AK145604
AKOS022186370
AOB87713
AS-16309
AX8268013
BC600328
BCP07042
BDBM50193013
CHEBI:131169
CHEMBL3039502
compound 4904 [Patent US8193182]
Copiktra (TN)
CS-0888
D10555
DB11952
DTXSID80152697
Duvelisib
Duvelisib (IPI-145 INK1197)
Duvelisib (IPI-145, INK1197)
Duvelisib (USAN/INN)
Duvelisib [USAN:INN]
Duvelisib monohydrate
EX-A1562
GTPL7795
HY-17044
INK-1147
INK-1197
INK-1197|||IPI-145|||8-Chloro-2-phenyl-3-[(1S)-1-(7H-purin-6-ylamino)ethyl]isoquinolin-1-one
INK1197
IPI 145
IPI-145
IPI-145 (INK1197)
IPI-145 pound>>Duvelisib
ipi-145-ink1197
IPI-145, INK 1197, Duvelisib
IPI145
KS-0000062P
MFCD15144635
NCGC00351482-01
QC-10232
s7028
SB16470
SCHEMBL153543
SCHEMBL18343557
SCHEMBL19670020
SCHEMBL20580104
SJVQHLPISAIATJ-ZDUSSCGKSA-N
ST24036081
SW219822-1
SYN1175
UNII-4WD61MR063
UNII-610V23S0JI
W-5592
X5816
ZINC88346058

US Patents and Regulatory Information for COPIKTRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Verastem Inc COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Verastem Inc COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Verastem Inc COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No   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

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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.