Viewing data from:

TAFLUPROST

ANDA

TAFLUPROST | A209051 | MICRO LABS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ZIOPTAN(TE code: AT)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SANTEN PHARMACEUTICAL CO. LTD. et al v. MICRO LABS LIMITED et al 3:2018cv12333 2 patentsANDA 209051tafluprost ophthalmic solution	D.N.J.	2018-08-01	Terminated 2018-10-24	—
Santen Pharmaceutical Co., Ltd. et al v. Micro Labs Limited et al 1:2016cv00353 1 patentANDA 209051tafluprost	D. Del.	2016-05-13	Terminated 2018-11-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

AGC INCTAFLUPROST DRUG SUBSTANCE

DMF 244002010

MSN LABORATORIES PRIVATE LTDTAFLUPROST [ROUTE CODE "TU"]

DMF 292062015

EVERLIGHT CHEMICAL INDUSTRIAL CORPTAFLUPROST

DMF 295642015

CHIROGATE INTERNATIONAL INCTAFLUPROST

DMF 336322019

CAYMAN PHARMA SROTAFLUPROST

DMF 357652021

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTAFLUPROST

DMF 395052024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 27, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.0015%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 19, 2019

No patent or exclusivity listings for this strength.