Medication Guide App

Generic Tyvaso Availability

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

TYVASO (treprostinil - solution;inhalation)

  • Manufacturer: UNITED THERAP
    Approval date: July 30, 2009
    Strength(s): EQ 0.6MG BASE/ML [RLD]

Has a generic version of Tyvaso been approved?

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

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

  • Method of treating pulmonary hypertension with benzidine prostaglandins
    Patent 5,153,222
    Issued: October 6, 1992
    Inventor(s): Tadepalli; Anjaneyulu S. & Long; Walker A. & Crow; James W. & Klein; Kenneth B.
    Assignee(s): Burroughs Wellcome Co.
    The present invention is concerned with methods for the prophylaxis, treatment and diagnosis of pulmonary hypertension which comprise the administrative of an effective amount of a compound of formula (I) ##STR1## wherein a is an integer of from 1 to 3; X and Y, which may be the same or different, are selected from --O-- and --CH.sub.2 --; R is --(CH.sub.2).sub.5 R.sup.1 wherein R.sup.1 is hydrogen or methyl, or R is cyclohexyl, or R is --CH(CH.sub.3)CH.sub.2 C.tbd.CCH.sub.3 ; and the dotted line represents an optional double bond; or of a physiologically acceptable salt or acid derivative thereof. Medicaments and diagnostic aids for use in the methods of the invention are also within the scope of the invention.
    Patent expiration dates:
    • October 16, 2014
      ✓ 
      Patent use: TREATMENT OF PULMONARY HYPERTENSION
  • Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation
    Patent 6,521,212
    Issued: February 18, 2003
    Inventor(s): Gilles; Cloutier & James; Crow & Michael; Wade & Richard E.; Parker & James E.; Loyd
    Assignee(s): United Therapeutics Corporation
    A method of delivering benzindene prostaglandins to a patient by inhalation is discussed. A benzindene prostaglandin known as UT-15 has unexpectedly superior results when administered by inhalation compared to parenterally administered UT-15 in sheep with induced pulmonary hypertension.
    Patent expiration dates:
    • November 13, 2018
      ✓ 
      Patent use: TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
  • Method for delivering benzindene prostaglandins by inhalation
    Patent 6,756,033
    Issued: June 29, 2004
    Inventor(s): Gilles; Cloutier & James; Crow & Michael; Wade & Richard E.; Parker & James E.; Loyd
    Assignee(s): United Therapeutics Corporation
    A method of delivering benzindene prostaglandins to a patient by inhalation is discussed. A benzindene prostaglandin known as UT-15 has unexpectedly superior results when administered by inhalation compared to parenterally administered UT-15 in sheep with induced pulmonary hypertension.
    Patent expiration dates:
    • November 13, 2018
      ✓ 
      Patent use: TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
  • 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
  • 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

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:
    • July 30, 2016 -

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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