Tobramycin - Generic Drug Details
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What are the generic drug sources for tobramycin and what is the scope of patent protection?
Tobramycin
is the generic ingredient in eleven branded drugs marketed by Novartis, Mylan Speciality Lp, Akorn, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Gland Pharma Ltd, Somerset Theraps Llc, Sandoz Inc, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Luoxin Aurovitas, Lupin, Mankind Pharma, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in sixty NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tobramycin has one hundred and sixteen patent family members in thirty-seven countries.
There are eighteen drug master file entries for tobramycin. Thirty-six suppliers are listed for this compound.
Summary for tobramycin
International Patents: | 116 |
US Patents: | 14 |
Tradenames: | 11 |
Applicants: | 33 |
NDAs: | 60 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 36 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 120 |
Patent Applications: | 6,178 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for tobramycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Medical University of South Carolina | Phase 4 |
Chris Goss | Phase 4 |
University of Washington | Phase 4 |
Pharmacology for tobramycin
Drug Class | Aminoglycoside Antibacterial |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | AN | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Hikma | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063118-001 | Jul 29, 1991 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789-001 | Jul 13, 2004 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Lupin | TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 208964-001 | Mar 22, 2017 | AN | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Hikma | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063128-001 | Nov 27, 1991 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 tobramycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | BETHKIS | tobramycin | SOLUTION;INHALATION | 201820-001 | Oct 12, 2012 | See Plans and Pricing | See Plans and Pricing |
Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | See Plans and Pricing | See Plans and Pricing |
Mylan Speciality Lp | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | See Plans and Pricing | See Plans and Pricing |
Chiesi | BETHKIS | tobramycin | SOLUTION;INHALATION | 201820-001 | Oct 12, 2012 | See Plans and Pricing | See Plans and Pricing |
Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for tobramycin
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Mylan Ireland 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 | yes | 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 |
International Patents for tobramycin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1765288 | See Plans and Pricing | |
Canada | 2520032 | APPAREIL DE PULVERISATION EN AEROSOL ET ECRAN DE PROTECTION D'ENTREE D'AIR (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD) | See Plans and Pricing |
Spain | 2383367 | See Plans and Pricing | |
Germany | 60103527 | See Plans and Pricing | |
Egypt | 24019 | Optimised formulation of tobramycin for aerosolization | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tobramycin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1280520 | 14/2015 | Austria | See Plans and Pricing | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
1280520 | C300722 | Netherlands | See Plans and Pricing | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
1280520 | 92678 | Luxembourg | See Plans and Pricing | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 |
1280520 | 122015000021 | Germany | See Plans and Pricing | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
1273292 | C01273292/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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