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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Federal Trade Commission
QuintilesIMS
Cipla
Citi
Queensland Health
Chinese Patent Office
Baxter
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Generated: December 16, 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 Ipsen Inc, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Ingenus Pharms Llc, Intas Pharms Usa, Jiangsu Hengrui Med, Mustafa Nevzat Ilac, Pliva Lachema, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty-five NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has sixty patent family members in twenty-one countries and four supplementary protection certificates in four countries.

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

Pharmacology for irinotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen IncONIVYDEirinotecan hydrochlorideINJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Mustafa Nevzat IlacIRINOTECAN HYDROCHLORIDEirinotecan hydrochlorideINJECTABLE;INJECTION090393-002May 13, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Ipsen IncONIVYDEirinotecan hydrochlorideINJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaIRINOTECAN HYDROCHLORIDEirinotecan hydrochlorideINJECTABLE;INJECTION077776-001Feb 27, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Ipsen IncONIVYDEirinotecan hydrochlorideINJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Ipsen IncONIVYDEirinotecan hydrochlorideINJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY► Subscribe
Sun Pharma GlobalIRINOTECAN HYDROCHLORIDEirinotecan hydrochlorideINJECTABLE;INJECTION078805-001Apr 21, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Actavis TotowaIRINOTECAN HYDROCHLORIDEirinotecan hydrochlorideINJECTABLE;INJECTION078589-003Nov 18, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Qilu Pharm Co LtdIRINOTECAN HYDROCHLORIDEirinotecan hydrochlorideINJECTABLE;INJECTION203380-002May 3, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Ipsen IncONIVYDEirinotecan hydrochlorideINJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY► 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 IncCAMPTOSARirinotecan hydrochlorideINJECTABLE;INJECTION020571-001Jun 14, 1996► Subscribe► Subscribe
Pfizer IncCAMPTOSARirinotecan hydrochlorideINJECTABLE;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
Canada2821167► Subscribe
Canada2566007► Subscribe
Russian Federation2011112461► Subscribe
Canada2928387► Subscribe
Denmark2861210► Subscribe
South Korea101223366► Subscribe
Japan2017149783► Subscribe
World Intellectual Property Organization (WIPO)0066125► Subscribe
South Korea20150021565► Subscribe
South Korea20120082039► 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
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
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
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Julphar
Fish and Richardson
Daiichi Sankyo
Queensland Health
QuintilesIMS
Healthtrust
Covington
Accenture

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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