DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022308
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.
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
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: | ➤ Try a Free Trial | Patent Expiration: | Jun 29, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING OCULAR BACTERIAL INFECTIONS | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Mar 31, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING OCULAR BACTERIAL INFECTIONS | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Nov 7, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING OCULAR BACTERIAL INFECTIONS | ||||||||
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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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