IRINOTECAN HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
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.
Summary for IRINOTECAN HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 23 |
NDAs: | 26 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 1,505 |
Patent Applications: | 3,287 |
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 |
---|---|
ECOG-ACRIN Cancer Research Group | Phase 3 |
Mirati Therapeutics | Phase 1 |
MEI Pharma, Inc. | Phase 1 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hospira | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078796-001 | Feb 27, 2008 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sun Pharma Global | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 078805-001 | Apr 21, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |