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Generic Orenitram Availability

Orenitram is a brand name of treprostinil, approved by the FDA in the following formulation(s):

ORENITRAM (treprostinil diolamine - tablet, extended release;oral)

  • Manufacturer: UNITED THERAP
    Approval date: December 20, 2013
    Strength(s): EQ 0.125MG BASE [RLD], EQ 0.25MG BASE [RLD], EQ 1MG BASE [RLD], EQ 2.5MG BASE [RLD]
  • Manufacturer: UNITED THERAP
    Approval date: October 7, 2016
    Strength(s): EQ 5MG BASE [RLD]

Has a generic version of Orenitram been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Orenitram. 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 FAQs.

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.

  • Compounds and methods for delivery of prostacyclin analogs
    Patent 7,417,070
    Issued: August 26, 2008
    Inventor(s): Phares; Ken & Mottola; David
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula:

    Patent expiration dates:

    • July 30, 2026
      ✓ 
      Drug substance
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 7,544,713
    Issued: June 9, 2009
    Inventor(s): Phares; Ken & Mottola; David
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula:

    Patent expiration dates:

    • July 14, 2024
      ✓ 
      Patent use: USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 8,252,839
    Issued: August 28, 2012
    Inventor(s): Phares; Ken & Mottola; David
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula.

    Patent expiration dates:

    • May 24, 2024
      ✓ 
      Drug product
  • Solid formulations of prostacyclin analogs
    Patent 8,349,892
    Issued: January 8, 2013
    Inventor(s): Phares; Kenneth R.
    Assignee(s): United Therapeutics Corporation

    Moderate moisture levels, such as greater than 3% but no greater than 7%, may be beneficial for solid formulations of certain prostacyclin analogs. Accordingly, a solid formulation containing a prostacyclin analog may be packaged inside a pharmaceutical packaging with such amount of a desiccant or a drying agent that after the storage the solid formulation may have a moderate level of moisture in it.

    Patent expiration dates:

    • January 22, 2031
      ✓ 
      Drug product
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 8,410,169
    Issued: April 2, 2013
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula:

    Patent expiration dates:

    • February 13, 2030
      ✓ 
      Drug product
  • Process to prepare treprostinil, the active ingredient in Remodulin®
    Patent 8,497,393
    Issued: July 30, 2013
    Assignee(s): United Therapeutics Corporation

    This present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance
      ✓ 
      Sponsor has requested patent be delisted
  • Osmotic drug delivery system
    Patent 8,747,897
    Issued: June 10, 2014
    Assignee(s): Supernus Pharmaceuticals, Inc.

    An oral osmotic pharmaceutical delivery system comprises a highly water-soluble drug exhibiting an erratic or an incomplete release profile when formulated in a elementary osmotic pump delivery system and at least one release enhancing agent.

    Patent expiration dates:

    • August 11, 2031
      ✓ 
      Patent use: A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
      ✓ 
      Drug product
    • August 11, 2031
      ✓ 
      Patent use: A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
      ✓ 
      Drug product
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 9,050,311
    Issued: June 9, 2015
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula:

    Patent expiration dates:

    • May 24, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 9,278,901
    Issued: March 8, 2016
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin formulations and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis.

    Patent expiration dates:

    • May 24, 2024
      ✓ 
      Patent use: USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
  • Osmotic drug delivery system
    Patent 9,393,203
    Issued: July 19, 2016
    Assignee(s): Supernus Pharmaceuticals, Inc.

    An oral osmotic pharmaceutical delivery system comprises a highly water-soluble drug exhibiting an erratic or an incomplete release profile when formulated in an elementary osmotic pump delivery system and at least one release enhancing agent.

    Patent expiration dates:

    • April 27, 2026
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      Patent use: METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
      ✓ 
      Drug product
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 9,422,223
    Issued: August 23, 2016
    Assignee(s): United Therapeutics Corporation

    This invention pertains generally to prostacyclin formulations and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis.

    Patent expiration dates:

    • May 24, 2024
      ✓ 
      Drug product
  • Process to prepare treprostinil, the active ingredient in remodulin®
    Patent 9,593,066
    Issued: March 14, 2017
    Assignee(s): United Therapeutics Corporation

    This present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance
  • Process to prepare treprostinil, the active ingredient in Remodulin®
    Patent 9,604,901
    Issued: March 28, 2017
    Assignee(s): United Therapeutics Corporation

    This present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.

    Patent expiration dates:

    • December 15, 2028
      ✓ 
      Drug substance

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:

    • October 18, 2022 - INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
    • October 18, 2026 -

Further information

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

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.