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Generic TOBI Podhaler Availability

Last updated on Sep 8, 2021.

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

TOBI PODHALER (tobramycin - powder;inhalation)

  • Manufacturer: MYLAN SPECIALITY LP
    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: Generic Drug FAQ.

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.

  • Aerosolization apparatus with capsule puncture alignment guide
    Patent 10,207,066
    Issued: February 19, 2019
    Assignee(s): BGP Products Operations GmbH

    An aerosolization apparatus comprises a housing defining a chamber having one or more air inlets. The chamber is sized to receive a capsule which contains an aerosolizable pharmaceutical formulation. The aerosolization apparatus further comprises a puncturing mechanism within the housing. The puncturing mechanism comprises an alignment guide and a puncture member, wherein the alignment guide comprises a surface adapted to contact the capsule while the puncture member is advanced into the capsule to create an opening in the capsule. At least a portion of the surface is sloped relative to the longitudinal axis of the capsule. Alternatively or additionally, the surface may comprise one or more protrusions. 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 capsule through the opening created in the capsule. The alignment guide allows for more consistent puncturing of the capsule and a longer lifetime of the apparatus.

    Patent expiration dates:

    • November 4, 2030
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      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
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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
  • 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
  • Methods of treatment of endobronchial infections
    Patent 8,664,187
    Issued: March 4, 2014
    Assignee(s): Novartis AG

    The present invention provides methods for the treatment of an endobronchial infection in a patient by administering to the endobronchial system of the patient a dry powder aerosol composition comprising from 90 to 130 mg of an aminoglycoside antibiotic one to three times a day for a first treatment period of 20 to 36 days.

    Patent expiration dates:

    • June 20, 2025
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      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
  • 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
  • Aerosolization apparatus with capsule puncturing member
    Patent 8,869,794
    Issued: October 28, 2014
    Assignee(s): Novartis Pharma AG

    An aerosolization apparatus comprises a housing defining a chamber having one or more air inlets. The chamber is sized to receive a capsule which contains an aerosolizable pharmaceutical formulation. A puncturing mechanism is provided within the housing and comprising a puncture member. The puncture member comprises a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule. The puncture member also comprises a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end. 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 capsule through the opening created in the capsule.

    Patent expiration dates:

    • September 12, 2028
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      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
      ✓ 
      Drug product
  • Pulmonary delivery of aminoglycoside
    Patent 9,421,166
    Issued: August 23, 2016
    Assignee(s): Novartis AG

    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
      ✓ 
      Patent use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
      ✓ 
      Drug product
  • Patent RE47526

    Patent expiration dates:

    • April 9, 2024
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.