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zioptan Drug Profile
» See Plans and Pricing
When do Zioptan patents expire, and what generic alternatives are available?
Zioptan is a drug marketed by Akorn and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-three patent family members in thirty-one countries.
The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. Additional details are available on the tafluprost profile page.
US ANDA Litigation and Generic Entry Outlook for Zioptan
A generic version of zioptan was approved as tafluprost by MICRO LABS on August 19th, 2019.
Summary for zioptan
| International Patents: | 83 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 44 |
| Patent Applications: | 49 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for zioptan |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for zioptan |
| DailyMed Link: | zioptan at DailyMed |
Paragraph IV (Patent) Challenges for ZIOPTAN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZIOPTAN | SOLUTION/DROPS;OPHTHALMIC | tafluprost | 202514 | 2016-02-10 |
US Patents and Regulatory Information for zioptan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Akorn | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514-001 | Feb 10, 2012 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Akorn | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514-001 | Feb 10, 2012 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for zioptan
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Luxembourg | 91943 | Start Trial |
| Mexico | 2010012987 | Start Trial |
| South Korea | 20200057801 | Start Trial |
| Taiwan | 536534 | Start Trial |
| Norway | 2009006 | Start Trial |
| European Patent Office | 3714877 | Start Trial |
| Taiwan | I432202 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for zioptan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0850926 | CA 2008 00041 | Denmark | Start Trial | |
| 0850926 | 91943 | Luxembourg | Start Trial | 91943, EXPIRES: 20221222 |
| 0850926 | SPC013/2011 | Ireland | Start Trial | SPC013/2011: 20110808, EXPIRES: 20221221 |
| 0850926 | 300407 | Netherlands | Start Trial | 300407, 20171222, EXPIRES: 20221221 |
| 0850926 | 339 | Finland | Start Trial | |
| 0850926 | SPC/GB09/005 | United Kingdom | Start Trial | PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017 |
| 0850926 | 11C0020 | France | Start Trial | PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
