TOBRADEX Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Tobradex, and what generic alternatives are available?
Tobradex is a drug marketed by Novartis, Sandoz, and Harrow Eye. and is included in three NDAs. There are three patents protecting this drug.
The generic ingredient in TOBRADEX 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.
DrugPatentWatch® Generic Entry Outlook for Tobradex
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TOBRADEX?
- What are the global sales for TOBRADEX?
- What is Average Wholesale Price for TOBRADEX?
Summary for TOBRADEX
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TOBRADEX |
| Drug Sales Revenues: | Drug sales revenues for TOBRADEX |
| What excipients (inactive ingredients) are in TOBRADEX? | TOBRADEX excipients list |
| DailyMed Link: | TOBRADEX at DailyMed |
Recent Clinical Trials for TOBRADEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sutphin Drugs | Early Phase 1 |
| NTC srl | Phase 3 |
| George Papanicolaou Hospital | N/A |
Pharmacology for TOBRADEX
| Drug Class | Aminoglycoside Antibacterial Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for TOBRADEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TOBRADEX | dexamethasone; tobramycin | OINTMENT;OPHTHALMIC | 050616-001 | Sep 28, 1988 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| Sandoz | TOBRADEX | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050592-001 | Aug 18, 1988 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TOBRADEX | dexamethasone; tobramycin | OINTMENT;OPHTHALMIC | 050616-001 | Sep 28, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | TOBRADEX | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050592-001 | Aug 18, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOBRADEX
See the table below for patents covering TOBRADEX 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 | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOBRADEX
| 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
