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Carboplatin - Generic Drug Details
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What are the generic drug sources for carboplatin and what is the scope of patent protection?
Carboplatin
is the generic ingredient in two branded drugs marketed by Cipla Ltd, Eugia Pharma, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pliva, Sandoz, Watson Labs Teva, West-ward Pharms Int, Corden Pharma, Accord Hlthcare, Actavis Totowa, Akorn, Gland Pharma Ltd, Meitheal, Mylan Institutional, Novast Labs, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Cordenpharma, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for carboplatin. Eight suppliers are listed for this compound.
Summary for carboplatin
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 24 |
NDAs: | 35 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 8 |
Bulk Api Vendors: | 27 |
Clinical Trials: | 2,408 |
Patent Applications: | 255 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for carboplatin |
DailyMed Link: | carboplatin at DailyMed |
Recent Clinical Trials for carboplatin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Andrew J. Armstrong, MD | Phase 2 |
Ipsen | Phase 2 |
Stanford University | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmachemie Bv | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077269-002 | Oct 14, 2004 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
Akorn | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 091268-002 | Jul 28, 2010 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Fresenius Kabi Usa | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077432-001 | Sep 29, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Hospira | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 076517-002 | Oct 14, 2004 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan Institutional | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077998-002 | Apr 24, 2007 | 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 |
Expired US Patents for carboplatin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Corden Pharma | PARAPLATIN | carboplatin | INJECTABLE;INJECTION | 019880-001 | Mar 3, 1989 | Start Trial | Start Trial |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-001 | Jul 14, 2003 | Start Trial | Start Trial |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-002 | Jul 14, 2003 | Start Trial | Start Trial |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-004 | Jan 15, 2004 | Start Trial | Start Trial |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-003 | Jul 14, 2003 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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