TOBREX Drug Patent Profile
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Which patents cover Tobrex, and when can generic versions of Tobrex launch?
Tobrex is a drug marketed by Novartis and Sandoz and is included in three NDAs.
The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tobrex
A generic version of TOBREX was approved as tobramycin by BAUSCH AND LOMB on November 29th, 1993.
Summary for TOBREX
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,245 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TOBREX |
| What excipients (inactive ingredients) are in TOBREX? | TOBREX excipients list |
| DailyMed Link: | TOBREX at DailyMed |
Recent Clinical Trials for TOBREX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alcon Research | Phase 1 |
| Alcon Research | Phase 3 |
Pharmacology for TOBREX
| Drug Class | Aminoglycoside Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for TOBREX
US Patents and Regulatory Information for TOBREX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TOBREX | tobramycin | OINTMENT;OPHTHALMIC | 050555-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | TOBREX | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 050541-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | TOBREX | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 062535-001 | Dec 13, 1984 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TOBREX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Viatris Healthcare Limited | Tobi Podhaler | tobramycin | EMEA/H/C/002155 Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2011-07-20 | |
| Pari Pharma GmbH | Vantobra (previously Tobramycin PARI) | tobramycin | EMEA/H/C/005086 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2019-02-18 | |
| Pari Pharma GmbH | Vantobra | tobramycin | EMEA/H/C/002633 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Withdrawn | no | no | no | 2015-03-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
