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ZIOPTAN Drug Profile

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Which patents cover Zioptan, and what substitute generic drugs are available?

Zioptan is a drug marketed by Oak Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in thirteen countries.

The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tafluprost profile page.

Summary for Tradename: ZIOPTAN

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list19
Patent Applications: see list29
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZIOPTAN at DailyMed

Pharmacology for Tradename: ZIOPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc
ZIOPTAN
tafluprost
SOLUTION/DROPS;OPHTHALMIC202514-001Feb 10, 2012RXYesYes5,886,035► SubscribeYY ► Subscribe
Oak Pharms Inc
ZIOPTAN
tafluprost
SOLUTION/DROPS;OPHTHALMIC202514-001Feb 10, 2012RXYesYes► Subscribe► Subscribe
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Paragraph IV activity for: ZIOPTAN

Drugname Dosage Strength RLD Submissiondate
tafluprostOphthalmic Solution0.0015%Zioptan2/10/2016

Non-Orange Book Patents for Tradename: ZIOPTAN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,985,920 Difluoroprostaglandin derivatives and their use► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZIOPTAN

Country Document Number Estimated Expiration
Netherlands300407► Subscribe
Germany122008000050► Subscribe
Germany69716226► Subscribe
China1187486► Subscribe
Japan2004002462► 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: ZIOPTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
9Finland► Subscribe
0850926/01Switzerland► SubscribePRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
C0020France► SubscribePRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430
943Luxembourg► Subscribe91943, EXPIRES: 20221222
C/GB09/005United Kingdom► SubscribePRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017
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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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