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Last Updated: January 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022308

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NDA 022308 describes BESIVANCE, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the BESIVANCE profile page.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.
Summary for 022308
Tradename:BESIVANCE
Applicant:Bausch And Lomb
Ingredient:besifloxacin hydrochloride
Patents:5
Generic Entry Opportunity Date for 022308
Generic Entry Date for 022308*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/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: 022308
Suppliers and Packaging for NDA: 022308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308 NDA Bausch & Lomb Incorporated 24208-446 24208-446-02 1 BOTTLE, DROPPER in 1 CARTON (24208-446-02) > 2 mL in 1 BOTTLE, DROPPER
BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308 NDA Bausch & Lomb Incorporated 24208-446 24208-446-05 1 BOTTLE, DROPPER in 1 CARTON (24208-446-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrengthEQ 0.6% BASE
Approval Date:May 28, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 29, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 7, 2030Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jan 9, 2031Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 022308

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009   Start Trial   Start Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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