TAFLUPROST - Generic Drug Details
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What are the generic drug sources for tafluprost and what is the scope of freedom to operate?
Tafluprost
is the generic ingredient in two branded drugs marketed by Ingenus Pharms Llc, Micro Labs, Sandoz, and Thea Pharma, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Tafluprost has eighty-one patent family members in twenty-six countries.
There are three drug master file entries for tafluprost. Four suppliers are listed for this compound.
Summary for TAFLUPROST
International Patents: | 81 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 29 |
Patent Applications: | 927 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for TAFLUPROST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAFLUPROST |
What excipients (inactive ingredients) are in TAFLUPROST? | TAFLUPROST excipients list |
DailyMed Link: | TAFLUPROST at DailyMed |
Recent Clinical Trials for TAFLUPROST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fondazione G.B. Bietti, IRCCS | Phase 4 |
Tun Hussein Onn National Eye Hospital | Phase 4 |
Taejoon Pharmaceutical Co., Ltd. | Phase 4 |
Pharmacology for TAFLUPROST
Drug Class | Prostaglandin Analog |
Mechanism of Action | Prostaglandin Receptor Agonists |
Physiological Effect | Increased Prostaglandin Activity |
Anatomical Therapeutic Chemical (ATC) Classes for TAFLUPROST
Paragraph IV (Patent) Challenges for TAFLUPROST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZIOPTAN | Ophthalmic Solution | tafluprost | 0.0015% | 202514 | 2 | 2016-02-10 |
US Patents and Regulatory Information for TAFLUPROST
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Thea Pharma | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514-001 | Feb 10, 2012 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Micro Labs | TAFLUPROST | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 209051-001 | Aug 19, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | TAFLUPROST | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 209040-001 | Jan 28, 2022 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 TAFLUPROST
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Thea Pharma | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514-001 | Feb 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TAFLUPROST
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2021120412 | 高眼圧症及び緑内障を治療するための方法及び組成物 (METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA) | ⤷ Sign Up |
Mexico | 2010012987 | METODO Y COMPOSICION PARA TRATAR HIPERTENSION OCULAR Y GLAUCOMA. (METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA.) | ⤷ Sign Up |
Poland | 3714877 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAFLUPROST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0850926 | 11C0020 | France | ⤷ Sign Up | PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430 |
0850926 | C00850926/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010 |
0850926 | SPC/GB09/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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