TOBRADEX ST Drug Patent Profile
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When do Tobradex St patents expire, and what generic alternatives are available?
Tobradex St is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.
The generic ingredient in TOBRADEX ST is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
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Summary for TOBRADEX ST
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TOBRADEX ST |
| What excipients (inactive ingredients) are in TOBRADEX ST? | TOBRADEX ST excipients list |
| DailyMed Link: | TOBRADEX ST at DailyMed |
Recent Clinical Trials for TOBRADEX ST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sutphin Drugs | Early Phase 1 |
| NTC srl | Phase 3 |
| Democritus University of Thrace | N/A |
Pharmacology for TOBRADEX ST
| Drug Class | Aminoglycoside Antibacterial Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for TOBRADEX ST
TOBRADEX ST is protected by three US patents.
Patents protecting TOBRADEX ST
Topical ophthalmic compositions containing tobramycin and dexamethasone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
Topical ophthalmic compositions containing tobramycin and dexamethasone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
Topical ophthalmic compositions containing tobramycin and dexamethasone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818-001 | Feb 13, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818-001 | Feb 13, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818-001 | Feb 13, 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 TOBRADEX ST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOBRADEX ST
See the table below for patents covering TOBRADEX ST around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 3347689 | ⤷ Sign Up | |
| European Patent Office | 0365613 | TOBRAMYCINE ET STEROIDES COMBINES DESTINES A UNE UTILISATION OPHTALMIQUE TOPIQUE. (COMBINATION OF TOBRAMYCIN AND STEROIDS FOR TOPICAL OPHTHALMIC USE.) | ⤷ Sign Up |
| Japan | H02503439 | ⤷ Sign Up | |
| Germany | 365613 | ⤷ Sign Up | |
| Japan | H08231405 | COMBINATION OF TOBRAMYCIN AND STEROID FOR LOCAL OPHTHALMOLOGICAL APPLICATION | ⤷ Sign Up |
| Germany | 68922688 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOBRADEX ST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| 1429780 | 13C0012 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
| 1581193 | SPC/GB12/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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