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Daiichi Sankyo
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Generated: December 17, 2017

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CIPRODEX Drug Profile

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When do Ciprodex patents expire, and what generic alternatives are available?

Ciprodex is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in twenty-two countries and three supplementary protection certificates in three countries.

The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpCIPRODEXciprofloxacin; dexamethasoneSUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for CIPRODEX

Drugname Dosage Strength RLD Submissiondate
ciprofloxacin and dexamethasoneOtic Suspension0.3%/0.1%Ciprodex7/31/2012

International Patent Family for Tradename: CIPRODEX

Country Document Number Estimated Expiration
Poland369205► Subscribe
Germany60208216► Subscribe
South Korea20040035760► Subscribe
Denmark1429780► Subscribe
MexicoPA02003130► Subscribe
China1555267► Subscribe
Turkey200200737► Subscribe
Poland359623► Subscribe
Saudi Arabia709► Subscribe
Poland212457► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CIPRODEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012France► SubscribePRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
2012 00045Denmark► Subscribe
C/GB12/058United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
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Serving leading biopharmaceutical companies globally:

McKinsey
Cipla
Johnson and Johnson
Argus Health
Cerilliant
Mallinckrodt
Baxter
Citi
Express Scripts
Cantor Fitzgerald

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.

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