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
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

See drug prices for TAFLUPROST

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

See all TAFLUPROST clinical trials

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

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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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
Ingenus Pharms Llc	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	218002-001	Apr 5, 2024		DISCN	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

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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

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Country	Patent Number	Title	Estimated Expiration
Portugal	3205334		⤷ Sign Up
Slovenia	2772249		⤷ Sign Up
Malaysia	159463	METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA	⤷ Sign Up
Canada	2965185	PROCEDE ET COMPOSITION UTILISABLES POUR LE TRAITEMENT DE L'HYPERTENSION OCULAIRE ET DU GLAUCOME (METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TAFLUPROST

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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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