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ALCAFTADINE

ANDA

ALCAFTADINE | A210659 | EUGIA PHARMA SPECIALITIES LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan, Inc. et al v. Aurobindo Pharma Ltd. et al 1:2017cv01290 1 patentANDA 210659alcaftadine	D. Del.	2017-09-08	Terminated 2018-11-26	—

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

API Supply Chain5 active DMFs1 inactive

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

CILAG AGALCAFTADINE (R89674) DRUG SUBSTANCE

DMF 200662006

CURIA SPAIN SAUALCAFTADINE

DMF 279822014

NEULAND LABORATORIES LTDALCAFTADINE

DMF 282772014

MSN LABORATORIES PRIVATE LTDALCAFTADINE [ROUTE CODE "FA"]

DMF 289322015

APICORE PHARMACEUTICALS PRIVATE LTDALCAFTADINE

DMF 323822018

ENALTEC LABS PRIVATE LTDInactiveALCAFTADINE

DMF 275592013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.25%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 23, 2023

No patent or exclusivity listings for this strength.