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Generic TOBI Podhaler Availability

TOBI Podhaler is a brand name of tobramycin, approved by the FDA in the following formulation(s):

TOBI PODHALER (tobramycin - powder;inhalation)

  • Manufacturer: NOVARTIS
    Approval date: March 22, 2013
    Strength(s): 28MG [RLD]

Has a generic version of TOBI Podhaler been approved?

No. There is currently no therapeutically equivalent version of TOBI Podhaler available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of TOBI Podhaler. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments
    Patent 7,097,827
    Issued: August 29, 2006
    Inventor(s): Platz; Robert M. & Patton; John S. & Foster; Linda & Eljamal; Mohammed
    Assignee(s): Inhale Therapeutic Systems, Inc.
    According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 μm mass median diameter (MMD), usually 1.0-4.0 μm MMD, and preferably 1.0-3.0 μm MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 μm mass median aerodynamic diameter (MMAD), usually 1.5-4.5 μm MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.
    Patent expiration dates:
    • April 16, 2016
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      Drug product
  • Pulmonary delivery of aminoglycosides
    Patent 7,368,102
    Issued: May 6, 2008
    Inventor(s): Tarara; Thomas E. & Weers; Jeffry G. & Venthoye; Geraldine
    Assignee(s): Nektar Therapeutics
    The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.
    Patent expiration dates:
    • December 19, 2022
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      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
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      Drug product
  • Phospholipid-based powders for drug delivery
    Patent 7,442,388
    Issued: October 28, 2008
    Inventor(s): Weers; Jeffry G. & Tarara; Thomas E. & Dellamary; Luis A. & Riess; Jean G. & Schutt; Ernest G.
    Phospholipid based powders for drug delivery applications are disclosed. The powders comprise a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.
    Patent expiration dates:
    • May 10, 2020
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      Drug product
  • Aerosolization apparatus with feedback mechanism
    Patent 7,516,741
    Issued: April 14, 2009
    Inventor(s): Glusker; Mark J. & Wood; Jeff R. & Burr; John D.
    Assignee(s): Novartis AG
    An aerosolization apparatus comprises a housing defining a chamber having an air inlet and an air outlet, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation. A puncturing member is moveable within the chamber to contact the capsule and to provide an opening in the capsule, and a feedback mechanism provides an indication, such as a tactile indication, to a user when the puncturing member has been moved to a position where it provides the opening into the capsule. When air flows through the inlet, the pharmaceutical formulation is aerosolized and the aerosolized pharmaceutical formulation is delivered through the outlet.
    Patent expiration dates:
    • January 11, 2024
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      Drug product
  • Aerosolization apparatus with air inlet shield
    Patent 7,559,325
    Issued: July 14, 2009
    Inventor(s): Dunkley; Michael John & Tuckwell; Jon David & Vernon Harcourt; Edward William & Shirgoankar; Sameer
    Assignee(s): Novartis Pharma AG
    An aerosolization apparatus comprises a housing defining a chamber having a plurality of air inlets. The chamber contains an aersolizable pharmaceutical formulation or is sized to receive a receptacle which contains an aerosolizable pharmaceutical formulation. A shield covers at least one of the air inlets or a portion of at least one of the air inlets. The shield prevents blockage of the air inlet by a user grasping the apparatus and inadvertently covering the air inlet. An end section is associated with the housing. The end section is sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the receptacle.
    Patent expiration dates:
    • October 27, 2025
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      Drug product
  • Aeorosolization apparatus with air inlet shield
    Patent 8,069,851
    Issued: December 6, 2011
    Inventor(s): Dunkley; Michael John & Tuckwell; Jon David & Vernon-Harcourt; Edward William & Shirgoankar; Sameer
    Assignee(s): Novartis AG
    An aerosolization apparatus comprises a housing defining a chamber having a plurality of air inlets. The chamber contains an aerosolizable pharmaceutical formulation or is sized to receive a receptacle which contains an aerosolizable pharmaceutical formulation. A shield covers at least one of the air inlets or a portion of at least one of the air inlets. The shield prevents blockage of the air inlet by a user grasping the apparatus and inadvertently covering the air inlet. An end section is associated with the housing. The end section is sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the receptacle.
    Patent expiration dates:
    • September 24, 2024
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      Drug product
  • Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
    Patent 8,349,294
    Issued: January 8, 2013
    Inventor(s): Dellamary; Luis A & Riess; Jean & Schutt; Ernest G & Weers; Jeffry G & Tarara; Thomas E
    Assignee(s): Novartis AG
    Microparticle compositions comprising metal ion-lipid complexes for drug delivery are described including methods of making the microparticle compositions and methods of treating certain conditions and disease states by administering the microparticle compositions. The metal ion-lipid complexes can be combined with various drugs or active agents for therapeutic administration. The microparticle compositions of the present invention have superior stability to other microparticle compositions resulting in a microparticle composition with longer shelf life and improved dispersability. The microparticle compositions of the present invention have a transition temperature (Tg) of at least 20° C. above the recommended storage temperature (Tst) for drug delivery.
    Patent expiration dates:
    • May 10, 2020
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      Drug product
  • Pulmonary delivery of aminoglycoside
    Patent 8,715,623
    Issued: May 6, 2014
    Assignee(s): Novartis AG
    A dispersible powder composition comprises aminoglycoside for delivery to the lungs. The composition is effective to provide a therapeutically effective therapy via administration of less than 6 respirable unit doses by inhalation, wherein each unit dose comprises a volume of 0.30 to 0.95 mL.
    Patent expiration dates:
    • December 19, 2022
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      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • March 22, 2016 - NEW PRODUCT

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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