TOBRAMYCIN Drug Patent Profile
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When do Tobramycin patents expire, and when can generic versions of Tobramycin launch?
Tobramycin is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Mylan, Sun Pharm, Teva Pharms Usa, Amneal, Padagis Us, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms. and is included in fifty-five NDAs.
The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tobramycin
A generic version of TOBRAMYCIN was approved as tobramycin sulfate by HIKMA on April 26th, 1991.
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Questions you can ask:
- What is the 5 year forecast for TOBRAMYCIN?
- What are the global sales for TOBRAMYCIN?
- What is Average Wholesale Price for TOBRAMYCIN?
Summary for TOBRAMYCIN
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 55 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 124 |
| Patent Applications: | 4,245 |
| Drug Prices: | Drug price information for TOBRAMYCIN |
| Drug Sales Revenues: | Drug sales revenues for TOBRAMYCIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOBRAMYCIN |
| What excipients (inactive ingredients) are in TOBRAMYCIN? | TOBRAMYCIN excipients list |
| DailyMed Link: | TOBRAMYCIN at DailyMed |
See drug prices for TOBRAMYCIN
Recent Clinical Trials for TOBRAMYCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clarametyx Biosciences, Inc. | Phase 1/Phase 2 |
| Shanghai Pulmonary Hospital, Shanghai, China | Phase 4 |
| University of Utah | Early Phase 1 |
Pharmacology for TOBRAMYCIN
| Drug Class | Aminoglycoside Antibacterial |
Medical Subject Heading (MeSH) Categories for TOBRAMYCIN
Anatomical Therapeutic Chemical (ATC) Classes for TOBRAMYCIN
Paragraph IV (Patent) Challenges for TOBRAMYCIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BETHKIS | Inhalation Solution | tobramycin | 300 mg/4 mL | 201820 | 1 | 2017-08-31 |
| TOBI | Inhalation Solution | tobramycin | 300 mg/5 mL | 050753 | 1 | 2009-06-29 |
US Patents and Regulatory Information for TOBRAMYCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063080-001 | Apr 30, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065122-002 | Nov 29, 2002 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Labs Ltd | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065407-001 | Mar 11, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | tobramycin sulfate | INJECTABLE;INJECTION | 063081-006 | Jun 2, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Igi Labs Inc | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063119-001 | Oct 31, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 TOBRAMYCIN
| 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 |
