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CARBOPLATIN Drug Profile
» See Plans and Pricing
Which patents cover Carboplatin, and when can generic versions of Carboplatin launch?
Carboplatin is a drug marketed by Cipla Ltd, Eugia Pharma, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pliva, Sandoz, Watson Labs Teva, West-ward Pharms Int, Accord Hlthcare, Actavis Totowa, Akorn, Gland Pharma Ltd, Meitheal, Mylan Institutional, Novast Labs, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sun Pharm, Teva Parenteral, and Teva Pharms Usa. and is included in thirty-three NDAs.
The generic ingredient in CARBOPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
US ANDA Litigation and Generic Entry Outlook for Carboplatin
A generic version of CARBOPLATIN was approved as carboplatin by HOSPIRA on October 14th, 2004.
Summary for CARBOPLATIN
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 33 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 2,376 |
| Patent Applications: | 161 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CARBOPLATIN |
| DailyMed Link: | CARBOPLATIN at DailyMed |
Recent Clinical Trials for CARBOPLATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ipsen | Phase 2 |
| Stanford University | Phase 3 |
| Joseph Sanchez Foundation | Phase 2 |
Pharmacology for CARBOPLATIN
| Drug Class | Platinum-based Drug |
Medical Subject Heading (MeSH) Categories for CARBOPLATIN
Paragraph IV (Patent) Challenges for CARBOPLATIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PARAPLATIN | INJECTABLE;INJECTION | carboplatin | 019880 | |
| PARAPLATIN | INJECTABLE;INTRAVENOUS | carboplatin | 020452 |
US Patents and Regulatory Information for CARBOPLATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 091063-002 | Nov 9, 2011 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Pharms Usa | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077139-003 | Sep 21, 2005 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cipla Ltd | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077861-003 | Jan 18, 2007 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Totowa | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 078732-002 | Feb 6, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pliva Lachema | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 078631-001 | Dec 2, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077247-001 | Oct 21, 2004 | 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 |
