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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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