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Serving leading biopharmaceutical companies globally:

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Dow
US Army
McKesson
Covington
Queensland Health
AstraZeneca
Deloitte
Argus Health
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Generated: October 18, 2017

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Irinotecan hydrochloride - Generic Drug Details

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What are the generic sources for irinotecan hydrochloride and what is the scope of irinotecan hydrochloride patent protection?

Irinotecan hydrochloride
is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Sun Pharma Global, Hospira, Hisun Pharm Hangzhou, Cipla Ltd, Pliva Lachema, Akorn, Hikma Farmaceutica, Ingenus Pharms Llc, Sandoz Inc, Dr Reddys Labs Ltd, West-ward Pharms Int, Intas Pharms Usa, Accord Hlthcare, Pfizer Inc, Emcure Pharms Ltd, Jiangsu Hengrui Med, Fresenius Kabi Usa, Qilu Pharm Co Ltd, Fresenius Kabi Oncol, Actavis Totowa, Ipsen Inc, Mustafa Nevzat Ilac, and Sandoz, and is included in twenty-five NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has fifty-eight patent family members in nineteen countries and four supplementary protection certificates in four countries.

There are thirty-two drug master file entries for irinotecan hydrochloride. Sixteen suppliers are listed for this compound.

Summary for Generic Name: irinotecan hydrochloride

US Patents:13
Tradenames:3
Applicants:24
NDAs:25
Drug Master File Entries: see list32
Suppliers / Packagers: see list16
Bulk Api Vendors: see list48
Clinical Trials: see list3,150
Patent Applications: see list5,104
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:irinotecan hydrochloride at DailyMed

Pharmacology for Ingredient: irinotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jiangsu Hengrui Med
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090675-001Dec 16, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cipla Ltd
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION077219-001Feb 20, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Hisun Pharm Hangzhou
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090016-001Jan 28, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Mustafa Nevzat Ilac
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090393-003May 13, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 1996APRXYesYes► Subscribe► SubscribeY► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Akorn
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090726-002Sep 16, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Jiangsu Hengrui Med
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090675-002Dec 16, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: irinotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996► Subscribe► Subscribe
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: irinotecan hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,658,203Liposomes useful for drug delivery to the brain► Subscribe
9,737,528Liposomes useful for drug delivery to the brain► Subscribe
9,717,723Liposomes useful for drug delivery► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: irinotecan hydrochloride

Country Document Number Estimated Expiration
China104717961► Subscribe
Russian Federation2011112461► Subscribe
Spain2632915► Subscribe
Canada2928387► Subscribe
Canada2821167► Subscribe
Hong Kong1209627► Subscribe
Japan2015523355► Subscribe
South Korea20120082039► Subscribe
Denmark2861210► Subscribe
South Korea20170104638► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: IRINOTECAN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885Netherlands► SubscribePRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
2017000042Germany► SubscribePRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014
2017 00030Denmark► SubscribePRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
C/GB97/010United Kingdom► SubscribePRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
US Army
UBS
Medtronic
Cantor Fitzgerald
Chubb
Teva
Covington
Express Scripts
Queensland Health

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.

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