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.
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 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: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | EQ 0.6% BASE | ||||
| Approval Date: | May 28, 2009 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Nov 7, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING OCULAR BACTERIAL INFECTIONS | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jan 9, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 12, 2030 | Product Flag? | Y | Substance Flag? | Delist 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 | See Plans and Pricing | See Plans and Pricing |
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | See Plans and Pricing | See Plans and Pricing |
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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