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LASTACAFT

NDA

ALCAFTADINE | N022134 | ABBVIE INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

Today

8664215

Dec. 23, 2027

10617695

Mar. 19, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases 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	—
Allergan, Inc. et al v. Somerset Therapeutics, LLC 1:2016cv00392 1 patentANDA 209126alcaftadine ophthalmic solution 0.25%	D. Del.	2016-05-26	Terminated 2016-12-08	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

6 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2022	SUPPL -9	View Letter (PDF)
Dec 15, 2021	SUPPL -8	View Letter (PDF)
Jun 10, 2020	SUPPL -7	View Letter (PDF)
Oct 2, 2015	SUPPL -4	View Letter (PDF)
Dec 5, 2014	SUPPL -1	View Letter (PDF)
Jul 30, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.25%

RLD

2 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jul 28, 2010

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8664215	Dec 23, 2027	—	—	—		—
10617695	Mar 19, 2027	—	—	Yes		—