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Generated: July 22, 2017
What is the competitive landscape for BAUSCH AND LOMB, and what generic alternatives to BAUSCH AND LOMB drugs are available?
BAUSCH AND LOMB has seventy-five approved drugs.| Patents: | 22 |
| Tradenames: | 64 |
| Ingredients: | 53 |
| NDAs: | 75 |
| 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 | LEVOBUNOLOL HYDROCHLORIDE | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 074307-001 | Mar 4, 1994 | AT | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bausch And Lomb | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SOLUTION/DROPS;OTIC | 064053-001 | Dec 29, 1995 | AT | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bausch And Lomb | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075585-001 | Dec 21, 2000 | AN | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bausch And Lomb | GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064048-001 | May 11, 1994 | AT | RX | No | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bausch And Lomb | ERYTHROMYCIN | erythromycin | OINTMENT;OPHTHALMIC | 064067-001 | Jul 29, 1994 | AT | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch And Lomb | ZYLET | loteprednol etabonate; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050804-001 | Dec 14, 2004 | 5,540,930*PED | ► Subscribe | ||||||||||||||||||||||
Bausch And Lomb | ZYLET | loteprednol etabonate; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050804-001 | Dec 14, 2004 | 5,747,061*PED | ► Subscribe | ||||||||||||||||||||||
Bausch And Lomb Inc | XIBROM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 021664-001 | Mar 24, 2005 | 4,910,225 | ► Subscribe | ||||||||||||||||||||||
Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803-001 | Mar 9, 1998 | 4,996,335*PED | ► Subscribe | ||||||||||||||||||||||
Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | 5,447,926 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
bepotastine besilate | Ophthalmic Solution | 1.5% | BEPREVE | 9/9/2013 |
bromfenac sodium | Ophthalmic Solution | 0.07% | PROLENSA | 7/26/2013 |
timolol maleate | Ophthalmic Solution | 0.5% | ISTALOL | 10/19/2012 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,056,893 | Topical treatment for prevention of ocular infections | ► Subscribe | |||||||||||||||||||||||||||
| 7,732,415 | Topical treatment or prevention of ocular infections | ► Subscribe | |||||||||||||||||||||||||||
| 8,252,307 | Method for treating and/or preventing retinal diseases with sustained release corticosteroids | ► Subscribe | |||||||||||||||||||||||||||
| 7,749,970 | Topical treatment of prevention of ocular infections | ► Subscribe | |||||||||||||||||||||||||||
| 8,883,825 | Aqueous liquid preparations and light-stabilized aqueous liquid preparations | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2012521433 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2011063619 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | WO2004011001 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0969812 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20110122202 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB97/014 | United Kingdom | ► Subscribe | PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216 | ||||||||||||||||||||||||||
| 2015000061 | Germany | ► Subscribe | PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826 | ||||||||||||||||||||||||||
| 2016 00031 | Denmark | ► Subscribe | PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326 | ||||||||||||||||||||||||||
| 2015 00043 | Denmark | ► Subscribe | PRODUCT NAME: TRASTUZUMAB OG REKOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: C(20135603) /EU/1/00/145/002 20130826 | ||||||||||||||||||||||||||
| 90041 | Netherlands | ► Subscribe | PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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.
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