Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
Fish and Richardson
Argus Health
Moodys
Accenture
Boehringer Ingelheim
Julphar
Dow

Generated: August 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022308

« Back to Dashboard

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 N 24208-446-02
BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308 NDA Bausch & Lomb Incorporated 24208-446 N 24208-446-05

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Express Scripts
Accenture
Mallinckrodt
UBS
AstraZeneca
US Department of Justice
Fish and Richardson
Chubb

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 verifification 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.