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 four 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:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022308

Generic Entry Date for 022308^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,481,526 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:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	EQ 0.6% BASE
Approval Date:	May 28, 2009	TE:		RLD:	Yes
Patent:	8,415,342	Patent Expiration:	Nov 7, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
Patent:	8,481,526	Patent Expiration:	Jan 9, 2031	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	8,604,020	Patent Expiration:	Mar 12, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022308

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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	5,447,926	⤷ Subscribe
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	6,699,492	⤷ Subscribe
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	6,685,958	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.