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Last Updated: September 27, 2020

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CISPLATIN Drug Profile

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Which patents cover Cisplatin, and what generic alternatives are available?

Cisplatin is a drug 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.

The generic ingredient in CISPLATIN is cisplatin. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

US ANDA Litigation and Generic Entry Outlook for Cisplatin

A generic version of CISPLATIN was approved as cisplatin by HQ SPCLT PHARMA on November 8th, 1988.

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Drug patent expirations by year for CISPLATIN
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
Accord Hlthcare CISPLATIN cisplatin INJECTABLE;INJECTION 206774-001 Aug 18, 2015 AP RX No 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
Fresenius Kabi Usa CISPLATIN cisplatin INJECTABLE;INJECTION 074735-001 Jul 16, 1999 AP RX No Yes   Start Trial   Start Trial   Start Trial
Pharmachemie Bv CISPLATIN cisplatin INJECTABLE;INJECTION 074656-001 May 16, 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
Bedford CISPLATIN cisplatin INJECTABLE;INJECTION 074713-002 Nov 14, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Hq Spclt Pharma CISPLATIN cisplatin INJECTABLE;INJECTION 018057-004 Nov 8, 1988 AP RX Yes 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 CISPLATIN cisplatin INJECTABLE;INJECTION 018057-004 Nov 8, 1988   Start Trial   Start Trial
Hq Spclt Pharma CISPLATIN cisplatin INJECTABLE;INJECTION 018057-004 Nov 8, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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