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Last Updated: February 9, 2023

Irinotecan hydrochloride - Generic Drug Details


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What are the generic sources for irinotecan hydrochloride and what is the scope of freedom to operate?

Irinotecan hydrochloride is the generic ingredient in three branded drugs marketed by Ipsen Inc, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Picket Pharms, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Sandoz Inc, Shilpa, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, and is included in twenty-eight NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has one hundred and eighteen patent family members in twenty-seven countries.

There are thirty drug master file entries for irinotecan hydrochloride. Eighteen suppliers are listed for this compound.

Summary for irinotecan hydrochloride
International Patents:118
US Patents:17
Tradenames:3
Applicants:26
NDAs:28
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 18
Raw Ingredient (Bulk) Api Vendors: 92
Clinical Trials: 1,476
Patent Applications: 6,077
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in irinotecan hydrochloride?irinotecan hydrochloride excipients list
DailyMed Link:irinotecan hydrochloride at DailyMed
Recent Clinical Trials for irinotecan hydrochloride

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

SponsorPhase
Kimberly PerezPhase 2
University of FloridaPhase 1
Fujian Medical UniversityPhase 2

See all irinotecan hydrochloride clinical trials

Pharmacology for irinotecan hydrochloride
Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CAMPTOSAR Injection irinotecan hydrochloride 20 mg/mL, 2 mL and 5 mL vials 020571 1 2004-07-26

US Patents and Regulatory Information 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 Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Intas Pharms Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203054-002 Aug 31, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077776-002 Feb 27, 2008 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 irinotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 See Plans and Pricing See Plans and Pricing
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 See Plans and Pricing See Plans and Pricing
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for irinotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 17C1027 France See Plans and Pricing PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 CA 2017 00030 Denmark See Plans and Pricing PRODUCT 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
1746976 122017000042 Germany See Plans and Pricing PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.