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, Hikma, Hq Spclt Pharma, Norvium Bioscience, Pharmachemie Bv, Qilu, and Teva Pharms Usa, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for cisplatin

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	10
Clinical Trials:	3,887
Drug Prices:	Drug price trends for cisplatin
What excipients (inactive ingredients) are in cisplatin?	cisplatin excipients list
DailyMed Link:	cisplatin at DailyMed

See drug prices for cisplatin

Recent Clinical Trials for cisplatin

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

Sponsor	Phase
EMD Serono	Phase 1
Fundación para el Progreso de la Oncología en Cantabria	Phase 2
Regeneron Pharmaceuticals	Phase 2

See all cisplatin clinical trials

Pharmacology for cisplatin

Drug Class	Platinum-based Drug

Medical Subject Heading (MeSH) Categories for cisplatin

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for cisplatin

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

US Patents and Regulatory Information for cisplatin

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Glossary

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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
Pharmachemie Bv	CISPLATIN	cisplatin	INJECTABLE;INJECTION	074656-001	May 16, 2000	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	CISPLATIN	cisplatin	INJECTABLE;INJECTION	091062-001	Apr 18, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	075036-001	Nov 7, 2000	AP	RX	No	No	⤷ 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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	018057-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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