CISPLATIN Drug Patent Profile

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Cisplatin is a drug marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Labs Ltd, Pharmachemie Bv, and Teva Pharms Usa. and is included in nine NDAs.

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

A generic version of CISPLATIN was approved as cisplatin by PHARMACHEMIE BV on May 16^th, 2000.

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	9
Clinical Trials:	3,845
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CISPLATIN
What excipients (inactive ingredients) are in CISPLATIN?	CISPLATIN excipients list
DailyMed Link:	CISPLATIN at DailyMed

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

Sponsor	Phase
Rajiv Gandhi Cancer Institute & Research Center, India	Phase 2
Varian, a Siemens Healthineers Company	Phase 2
Arcus Biosciences, Inc.	Phase 2

Drug Class	Platinum-based Drug

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

L01XA	Platinum compounds
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	CISPLATIN	cisplatin	INJECTABLE;INJECTION	074735-001	Jul 16, 1999	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bedford	CISPLATIN	cisplatin	INJECTABLE;INJECTION	074713-001	Nov 14, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bedford	CISPLATIN	cisplatin	INJECTABLE;INJECTION	074713-002	Nov 14, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering CISPLATIN around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	362052		⤷ Sign Up
Japan	S619923		⤷ Sign Up
Japan	S54157817	PHARMACEUTICAL PREPARED SOLUTION	⤷ Sign Up
South Africa	7900395		⤷ Sign Up
German Democratic Republic	142293	VERFAHREN ZUR HERSTELLUNG EINES PHARMAZEUTISCHEN MITTELS	⤷ Sign Up
Finland	66121		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration