.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Express Scripts
Merck
Fish and Richardson
Citi
Boehringer Ingelheim
Moodys
Cipla
Daiichi Sankyo

Generated: December 15, 2017

DrugPatentWatch Database Preview

Tobramycin - Generic Drug Details

« Back to Dashboard

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 Novartis Pharms Corp, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Sandoz Inc, Chiesi Usa Inc, Pulmoflow Inc, Novartis Pharms, Akorn Inc, Amneal Pharms, Lupin Atlantis, Mylan Pharms Inc, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in forty-nine NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has two hundred and twenty-six patent family members in forty countries and seven supplementary protection certificates in six countries.

There are eighteen drug master file entries for tobramycin. Twenty-seven suppliers are listed for this compound.

Pharmacology for tobramycin

Medical Subject Heading (MeSH) Categories for tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
HospiraTOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERtobramycin sulfateINJECTABLE;INJECTION063081-006Jun 2, 1993RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaTOBRAMYCIN SULFATE (PHARMACY BULK)tobramycin sulfateINJECTABLE;INJECTION065120-001Nov 29, 2002RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Fera PharmsTOBRAMYCINtobramycinSOLUTION/DROPS;OPHTHALMIC065026-001Sep 11, 2001ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntTOBRAMYCIN SULFATEtobramycin sulfateINJECTABLE;INJECTION063127-001Nov 27, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTOBREXtobramycinSOLUTION/DROPS;OPHTHALMIC050541-001Approved Prior to Jan 1, 1982ATRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Lupin AtlantisTOBRAMYCINtobramycinSOLUTION;INHALATION208964-001Mar 22, 2017ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncTOBRAMYCINtobramycinSOLUTION/DROPS;OPHTHALMIC065087-001Feb 25, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson Labs IncTOBRAMYCIN SULFATEtobramycin sulfateINJECTABLE;INJECTION062945-001Aug 9, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaTOBRAMYCINtobramycinSOLUTION;INHALATION091589-001Oct 10, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
HospiraTOBRAMYCIN SULFATEtobramycin sulfateINJECTABLE;INJECTION063161-001May 29, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013► Subscribe► Subscribe
Novartis PharmsTOBItobramycinSOLUTION;INHALATION050753-001Dec 22, 1997► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: tobramycin

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
8,404,217Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use► Subscribe
8,168,223Engineered particles and methods of use► Subscribe
7,205,343Stabilized bioactive preparations and method of use► Subscribe
8,709,484Phospholipid-based powders for drug delivery► Subscribe
7,905,230Metered dose inhaler with lockout► Subscribe
7,628,978Stabilized preparations for use in metered dose inhalers► Subscribe
6,309,623 Stabilized preparations for use in metered dose inhalers► Subscribe
9,439,862Phospholipid-based powders for drug delivery► Subscribe
7,306,787Engineered particles and methods of use► Subscribe
8,246,934Respiratory dispersion for metered dose inhalers comprising perforated microstructures► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: tobramycin

Country Document Number Estimated Expiration
Austria248583► Subscribe
World Intellectual Property Organization (WIPO)03053411► Subscribe
Australia2004229446► Subscribe
Czech Republic300758► Subscribe
World Intellectual Property Organization (WIPO)0193932► Subscribe
Germany60103527► Subscribe
Slovenia1458360► Subscribe
Japan2013237681► Subscribe
World Intellectual Property Organization (WIPO)9916421► Subscribe
World Intellectual Property Organization (WIPO)2006002140► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: TOBRAMYCIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1273292/01Switzerland► SubscribePRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
2015000021Germany► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
2015 00017Denmark► SubscribePRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
0722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2015Austria► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
00722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Novartis
QuintilesIMS
Cerilliant
Colorcon
US Department of Justice
Farmers Insurance
Cantor Fitzgerald
Covington
Moodys

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot