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Generated: June 28, 2017
What are the generic drug sources for tobramycin and what is the scope of tobramycin patent protection?
Tobramycin is the generic ingredient in eleven branded drugs marketed by Amneal Pharms, Chiesi Usa Inc, Akorn Inc, Fera Pharms, Pulmoflow Inc, Sandoz Inc, Novartis Pharms Corp, Bausch And Lomb, Novartis Pharms, Lupin Atlantis, Alcon Pharms Ltd, Apotex Inc, Novartis, Teva Pharms Usa, Akorn, Lilly, Mylan Labs Ltd, Hospira, West-ward Pharms Int, X Gen Pharms, Igi Labs Inc, Fresenius Kabi Usa, Apothecon, Watson Labs Inc, Claris, and Xellia Pharms Aps, and is included in forty-seven NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 11 |
| Patents: | 11 |
| Applicants: | 26 |
| NDAs: | 47 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 26 |
| Bulk Api Vendors: see list | 43 |
| Clinical Trials: see list | 90 |
| Patent Applications: see list | 6,662 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | tobramycin at DailyMed |
| Ingredient-type | Aminoglycosides |
| Drug Class | Aminoglycoside Antibacterial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
West-ward Pharms Int | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063117-001 | Apr 26, 1991 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms Usa | TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 091589-001 | Oct 10, 2013 | AN | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065122-001 | Nov 29, 2002 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063100-001 | Jan 30, 1992 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Igi Labs Inc | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063120-001 | Oct 31, 1994 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | 5,508,269 | ► Subscribe | ||||||||||||||||||||||
Novartis | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,097,827 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,473,433 | Pulmonary delivery of polyene antifungal agents | ► Subscribe | |||||||||||||||||||||||||||
| 7,628,978 | Stabilized preparations for use in metered dose inhalers | ► Subscribe | |||||||||||||||||||||||||||
| 8,709,484 | Phospholipid-based powders for drug delivery | ► Subscribe | |||||||||||||||||||||||||||
| 6,309,623 | Stabilized preparations for use in metered dose inhalers | ► Subscribe | |||||||||||||||||||||||||||
| 7,306,787 | Engineered particles and methods of use | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 9677298 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101066788 | ► Subscribe | |||||||||||||||||||||||||||
| Slovakia | 285806 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2222294 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2335940 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 00017 | Denmark | ► Subscribe | PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720 | ||||||||||||||||||||||||||
| 678 | Luxembourg | ► Subscribe | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 | ||||||||||||||||||||||||||
| 00722 | Netherlands | ► Subscribe | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 | ||||||||||||||||||||||||||
| 2015000021 | Germany | ► Subscribe | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 | ||||||||||||||||||||||||||
| 0722 | Netherlands | ► Subscribe | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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