Viewing data from:

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan, Inc. et al v. Gland Pharma Limited 1:2020cv00932	D. Del.	2020-07-09	Terminated 2021-03-11	—
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

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy Study of a Eye Drop for Eye Allergy NCT00889330	Phase 3	Completed	Vistakon Pharmaceuticals	60	2009-04
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis NCT01732757	Phase 4	Completed	Allergan	157	2012-11 → 2012-12
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis NCT01470118	Phase 4	Completed	Allergan	127	2011-10 → 2011-12
Ocular Allergy Treatment Practical Impact Trial NCT01808768	Phase 4	UNKNOWN	Starx Research Center, LLC	50	2013-04 → 2013-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.83

per ml

Lowest NADAC/Unit

$2.83

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00023429105LASTACAFT ONCE DAILY 0.25% DRP	$2.83	ML	Brand	—	2026-05-20

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$12.85

Highest Price

$21.42

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00023-4291-05LASTACAFT ONCE DAILY RELIEF	$12.85	FSS	Abbvie US LLC	07/31/2030
00023-4291-10LASTACAFT ONCE DAILY RELIEF	$21.42	FSS	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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) · 2 use codes

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