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Irinotecan hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for irinotecan hydrochloride?

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, Sandoz Inc, Dr Reddys Labs Ltd, West-ward Pharms Int, Accord Hlthcare, Pfizer Inc, Emcure Pharms Ltd, Jiangsu Hengrui Med, Fresenius Kabi Usa, Qilu Pharm Co Ltd, Fresenius Kabi Oncol, Actavis Totowa, Merrimack Pharms, Mustafa Nevzat Ilac, and Sandoz, and is included in twenty-three NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has forty-six patent family members in fifteen countries.

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

Summary for Generic Name: irinotecan hydrochloride

Tradenames:3
Patents:11
Applicants:22
NDAs:23
Drug Master File Entries: see list32
Suppliers / Packagers: see list13
Bulk Api Vendors: see list48
Clinical Trials: see list1,319
Patent Applications: see list4,803
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090726-001Sep 16, 2009RXNoNo► Subscribe► Subscribe
Jiangsu Hengrui Med
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090675-002Dec 16, 2011RXNoNo► Subscribe► Subscribe
Sandoz Inc
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION090137-002Nov 12, 2009RXNoNo► Subscribe► Subscribe
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996RXYesYes6,794,370*PED► SubscribeY► Subscribe
Cipla Ltd
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION077219-002Feb 20, 2008RXNoNo► 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, 19964,604,463*PED► Subscribe
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 19964,604,463*PED► 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
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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
European Patent Office1746976► Subscribe
Russian Federation2006142766► Subscribe
Japan2012092119► Subscribe
South Korea101462825► Subscribe
China103948545► 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
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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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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