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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022134


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NDA 022134 describes LASTACAFT, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LASTACAFT profile page.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alcaftadine profile page.
Summary for 022134
Tradename:LASTACAFT
Applicant:Allergan
Ingredient:alcaftadine
Patents:2
Generic Entry Opportunity Date for 022134
Generic Entry Date for 022134*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022134
Suppliers and Packaging for NDA: 022134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134 NDA Allergan, Inc. 0023-4290 0023-4290-01 1 BOTTLE, PLASTIC in 1 CARTON (0023-4290-01) > 1 mL in 1 BOTTLE, PLASTIC
LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134 NDA Allergan, Inc. 0023-4290 0023-4290-03 1 BOTTLE, PLASTIC in 1 CARTON (0023-4290-03) > 3 mL in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 022134
Tradename Dosage Ingredient NDA Submissiondate
LASTACAFT SOLUTION/DROPS;OPHTHALMIC alcaftadine 022134 2014-07-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.25%
Approval Date:Jul 28, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR PREVENTING ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Patent:  Start TrialPatent Expiration:Dec 23, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR PREVENTING ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

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