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Generated: October 19, 2018

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 two suppliers. There are six 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. Two suppliers are 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:6
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
Ingredient-typeQuinolones
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:➤ Sign UpPatent Expiration:Jun 29, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
Patent:➤ Sign UpPatent Expiration:Mar 31, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
Patent:➤ Sign UpPatent Expiration:Nov 7, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

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