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IRINOTECAN HYDROCHLORIDE Drug Profile
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Which patents cover Irinotecan Hydrochloride, and what generic alternatives are available?
Irinotecan Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Jiangsu Hengrui Med, Neopharma, Novast Labs, Pliva Lachema, Qilu, Sandoz, Sandoz Inc, Shilpa Medicare Ltd, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova. and is included in twenty-six NDAs.
The generic ingredient in IRINOTECAN HYDROCHLORIDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Irinotecan Hydrochloride
A generic version of IRINOTECAN HYDROCHLORIDE was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27th, 2008.
Summary for IRINOTECAN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 26 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 80 |
| Clinical Trials: | 1,296 |
| Patent Applications: | 4,533 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | IRINOTECAN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for IRINOTECAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Asan Medical Center | Phase 1/Phase 2 |
| Hallym University Medical Center | Phase 1/Phase 2 |
| University of Cologne | Phase 2 |
Pharmacology for IRINOTECAN HYDROCHLORIDE
| Drug Class | Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CAMPTOSAR | INJECTABLE;INJECTION | irinotecan hydrochloride | 020571 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 077994-001 | Feb 27, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Neopharma | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078953-001 | Apr 15, 2010 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharma Global | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078805-002 | Apr 21, 2008 | DISCN | No | 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 |
