IRINOTECAN HYDROCHLORIDE Drug Patent 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, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, 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. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
DrugPatentWatch® 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.
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Questions you can ask:
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Summary for IRINOTECAN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 23 |
| NDAs: | 26 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 1,545 |
| Patent Applications: | 4,335 |
| DailyMed Link: | IRINOTECAN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for IRINOTECAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oncotelic Inc. | Phase 2/Phase 3 |
| State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
| Harbin Medical University | Phase 2 |
Pharmacology for IRINOTECAN HYDROCHLORIDE
| Drug Class | Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Qilu Pharm Hainan | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 203380-003 | May 3, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078796-001 | Feb 27, 2008 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharma Global | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078805-001 | Apr 21, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
