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Last Updated: September 27, 2020

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Cisplatin - Generic Drug Details

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What are the generic drug sources for cisplatin and what is the scope of freedom to operate?

Cisplatin is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hq Spclt Pharma, Mylan Labs Ltd, Pharmachemie Bv, Teva Pharms Usa, and West-ward Pharms Int, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for cisplatin. Eight suppliers are listed for this compound.

Drug Prices for cisplatin

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Recent Clinical Trials for cisplatin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NRG OncologyPhase 1
Instituto Oncológico Dr RosellPhase 1/Phase 2
Fundacion Clinic per a la Recerca BiomédicaPhase 1/Phase 2

See all cisplatin clinical trials

Pharmacology for cisplatin
Medical Subject Heading (MeSH) Categories for cisplatin
Paragraph IV (Patent) Challenges for CISPLATIN
Tradename Dosage Ingredient NDA Submissiondate
CISPLATIN INJECTABLE;INJECTION cisplatin 018057
PLATINOL INJECTABLE;INJECTION cisplatin 018057
PLATINOL-AQ INJECTABLE;INJECTION cisplatin 018057

US Patents and Regulatory Information for cisplatin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hq Spclt Pharma PLATINOL-AQ cisplatin INJECTABLE;INJECTION 018057-003 Jul 18, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd CISPLATIN cisplatin INJECTABLE;INJECTION 091062-001 Apr 18, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int CISPLATIN cisplatin INJECTABLE;INJECTION 075036-001 Nov 7, 2000 AP RX No No   Start Trial   Start Trial   Start Trial
Bedford CISPLATIN cisplatin INJECTABLE;INJECTION 074713-001 Nov 14, 2000 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 cisplatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hq Spclt Pharma CISPLATIN cisplatin INJECTABLE;INJECTION 018057-004 Nov 8, 1988   Start Trial   Start Trial
Hq Spclt Pharma PLATINOL-AQ cisplatin INJECTABLE;INJECTION 018057-003 Jul 18, 1984   Start Trial   Start Trial
Hq Spclt Pharma PLATINOL-AQ cisplatin INJECTABLE;INJECTION 018057-003 Jul 18, 1984   Start Trial   Start Trial
Hq Spclt Pharma PLATINOL cisplatin INJECTABLE;INJECTION 018057-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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