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ZIOPTAN Drug Profile

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Zioptan is a drug marketed by Oak Pharms Inc and is included in one NDA. It is available from two suppliers. 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. Two suppliers are 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 list2
Drug Prices: :see details

Pharmacology for Tradename: ZIOPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc
ZIOPTAN
tafluprost
SOLUTION/DROPS;OPHTHALMIC202514-001Feb 10, 2012RXYes5,886,035► subscribeYY ► subscribe
Oak Pharms Inc
ZIOPTAN
tafluprost
SOLUTION/DROPS;OPHTHALMIC202514-001Feb 10, 2012RXYes► 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
Denmark0850926► subscribe
Canada2225761► subscribe
Norway976085► 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
C013/2011Ireland► subscribeSPC013/2011: 20110808, EXPIRES: 20221221
C/GB09/005United Kingdom► subscribePRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017
9Finland► subscribe
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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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