BESIVANCE Drug Patent Profile
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Which patents cover Besivance, and when can generic versions of Besivance launch?
Besivance is a drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this drug.
This drug has twenty-four patent family members in thirteen countries.
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.
DrugPatentWatch® Generic Entry Outlook for Besivance
Besivance was eligible for patent challenges on May 28, 2013.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 9, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for BESIVANCE?
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Summary for BESIVANCE
| International Patents: | 24 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 13 |
| Patent Applications: | 17 |
| Drug Prices: | Drug price information for BESIVANCE |
| What excipients (inactive ingredients) are in BESIVANCE? | BESIVANCE excipients list |
| DailyMed Link: | BESIVANCE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BESIVANCE
*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.
Recent Clinical Trials for BESIVANCE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sight Medical Doctors PLLC | Phase 4 |
| Ocular Therapeutix, Inc. | Phase 4 |
| Rutgers, The State University of New Jersey | Phase 1 |
Pharmacology for BESIVANCE
| Drug Class | Quinolone Antimicrobial |
US Patents and Regulatory Information for BESIVANCE
BESIVANCE is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BESIVANCE is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BESIVANCE
Besifloxacin ophthalmic composition for the treatment or control of infection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
Fluoroquinolone carboxylic acid molecular crystals
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fluoroquinolone carboxylic acid molecular crystals
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BESIVANCE
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BESIVANCE
When does loss-of-exclusivity occur for BESIVANCE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5926
Patent: CRISTALES MOLECULARES DE ACIDO CARBOXILICO DE FLUOROQUINOLONA
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 1009849
Patent: forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 56769
Patent: CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2369189
Patent: Fluoroquinolone carboxylic acid molecular crystals
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 11369
Patent: CRISTAUX MOLÉCULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 12521433
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11009758
Patent: CRISTALES MOLECULARES DE FLUOROQUINOLONA ACIDO CARBOXILICO. (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS.)
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 110122202
Patent: FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 68394
Estimated Expiration: ⤷ Sign Up
Patent: 1038536
Patent: Fluoroquinolone carboxylic acid molecular crystals
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BESIVANCE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2445408 | COMPOSITIONS D'ACIDE QUINOLONE CARBOXYLIQUE ET METHODES DE TRAITEMENT ASSOCIEES (QUINOLONE CARBOXYLIC ACID COMPOSITIONS AND RELATED METHODS OF TREATMENT) | ⤷ Sign Up |
| Australia | 772228 | ⤷ Sign Up | |
| Canada | 2065846 | DERIVES D'ACIDE QUINOLONECARBOXYLIQUE (QUINOLONE CARBOXYLIC ACID DERIVATIVES) | ⤷ Sign Up |
| Japan | 2805460 | ⤷ Sign Up | |
| Mexico | PA01009718 | TRATAMIENTO TOPICO O PREVENCION DE INFECCIONES OCULARES. (TOPICAL TREATMENT OR PREVENTION OF OCULAR INFECTIONS.) | ⤷ Sign Up |
| Denmark | 0493608 | ⤷ Sign Up | |
| Japan | 4904621 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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