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Generic Remodulin Availability

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

REMODULIN (treprostinil - injectable;iv (infusion), subcutaneous)

  • Manufacturer: UNITED THERAP
    Approval date: May 21, 2002
    Strength(s): 1MG/ML, 2.5MG/ML, 5MG/ML, 10MG/ML [RLD]

Has a generic version of Remodulin been approved?

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

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

  • Process for stereoselective synthesis of prostacyclin derivatives
    Patent 6,765,117
    Issued: July 20, 2004
    Inventor(s): Robert M.; Moriarty & Raju; Penmasta & Liang; Guo & Munagala S.; Rao & James P.; Staszewski
    Assignee(s): United Therapeutic Corporation
    An improved method is described for making 9-deoxy-PGF1-type compounds. In contrast to the prior art, the method is stereoselective and requires fewer steps than the known methods for making these compounds. The invention also relates to novel intermediates prepared during the synthesis of the 9-deoxy-PGF1-type compounds.
    Patent expiration dates:
    • October 24, 2017
      ✓ 
      Drug substance
  • Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
    Patent 7,999,007
    Issued: August 16, 2011
    Inventor(s): Jeffs; Roger & Zaccardelli; David
    Assignee(s): United Therapeutics Corporation
    Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
    Patent expiration dates:
    • March 29, 2029
      ✓ 
      Patent use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
      ✓ 
      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
  • Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
    Patent 8,653,137
    Issued: February 18, 2014
    Assignee(s): United Therapeutics Corporation
    Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
    Patent expiration dates:
    • September 5, 2028
      ✓ 
      Patent use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
  • Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
    Patent 8,658,694
    Issued: February 25, 2014
    Assignee(s): United Therapeutics Corporation
    Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
    Patent expiration dates:
    • September 5, 2028
      ✓ 
      Patent use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
  • Compounds and methods for delivery of prostacyclin analogs
    Patent 9,199,908
    Issued: December 1, 2015
    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: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION

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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