Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Mallinckrodt
Merck
AstraZeneca
Boehringer Ingelheim

Last Updated: December 13, 2019

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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. Nine 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 launched as cisplatin by HQ SPCLT PHARMA on December 13th, 2019.

Drug patent expirations by year for CISPLATIN
Drug Prices for CISPLATIN

See drug prices for CISPLATIN

Recent Clinical Trials for CISPLATIN

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

SponsorPhase
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaPhase 2
HaiNan Province Tumor HospitalPhase 3
SiChuan Province Tumor HospitalPhase 3

See all CISPLATIN clinical trials

Recent Litigation for CISPLATIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pharmacia & Upjohn v. Sicor Inc.2004-07-08

See all CISPLATIN litigation

Pharmacology for CISPLATIN
Medical Subject Heading (MeSH) Categories for CISPLATIN
Paragraph IV (Patent) Challenges for CISPLATIN
Tradename Dosage Ingredient NDA Submissiondate
PLATINOL-AQ INJECTABLE;INJECTION cisplatin 018057
CISPLATIN INJECTABLE;INJECTION cisplatin 018057
PLATINOL 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 AP RX 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
>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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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
McKinsey
Harvard Business School
Colorcon
Dow

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 verifification 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.