Generic Remodulin Availability
Last updated on Oct 9, 2024.
Remodulin is a brand name of treprostinil, approved by the FDA in the following formulation(s):
REMODULIN (treprostinil - injectable;iv (infusion), subcutaneous)
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Manufacturer: UNITED THERAP
Approval date: May 21, 2002
Strength(s): 1MG/ML [RLD] [AP], 2.5MG/ML [RLD] [AP], 5MG/ML [RLD] [AP], 10MG/ML [RLD] [AP] -
Manufacturer: UNITED THERAP
Approval date: July 30, 2021
Strength(s): 20MG/ML [RLD] -
Manufacturer: UNITED THERAP
Approval date: September 28, 2023
Strength(s): 0.1MG/ML [RLD], 0.2MG/ML [RLD], 0.4MG/ML [RLD]
REMODULIN (treprostinil - solution;intravenous, subcutaneous)
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Manufacturer: UNITED THERAP
Approval date: July 30, 2018
Strength(s): 20MG/20ML (1MG/ML) (discontinued), 50MG/20ML (2.5MG/ML) (discontinued), 100MG/20ML (5MG/ML) (discontinued), 200MG/20ML (10MG/ML) (discontinued)
Has a generic version of Remodulin been approved?
A generic version of Remodulin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Remodulin and have been approved by the FDA:
treprostinil injectable;iv (infusion), subcutaneous
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Manufacturer: ALEMBIC GLOBAL
Approval date: February 11, 2021
Strength(s): 1MG/ML [AP], 2.5MG/ML [AP], 5MG/ML [AP], 10MG/ML [AP] -
Manufacturer: DR REDDYS
Approval date: May 22, 2020
Strength(s): 1MG/ML [AP], 2.5MG/ML [AP], 5MG/ML [AP], 10MG/ML [AP] -
Manufacturer: ENDO OPERATIONS
Approval date: September 24, 2019
Strength(s): 1MG/ML [AP], 2.5MG/ML [AP], 5MG/ML [AP], 10MG/ML [AP] -
Manufacturer: SANDOZ
Approval date: November 30, 2017
Strength(s): 1MG/ML [AP], 2.5MG/ML [AP], 5MG/ML [AP], 10MG/ML [AP] -
Manufacturer: TEVA PHARMS USA
Approval date: September 26, 2019
Strength(s): 1MG/ML [AP], 2.5MG/ML [AP], 5MG/ML [AP], 10MG/ML [AP]
Note: No generic formulation of the following product is available.
- treprostinil - solution;intravenous, subcutaneous
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: 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.
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Inhalation formulations of Treprostinil
Patent 10,076,505
Issued: September 18, 2018
Inventor(s): Wade Michael
Assignee(s): United Therapeutics CorporationThe present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 16, 2024✓
- December 16, 2024
-
Inhalation formulations of treprostinil
Patent 10,695,308
Issued: June 30, 2020
Inventor(s): Wade Michael
Assignee(s): United Therapeutics CorporationThe present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 16, 2024✓
- December 16, 2024
-
Patent 11,723,887
Patent expiration dates:
- December 15, 2028✓
- December 15, 2028
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Patent 7,999,007
Patent expiration dates:
- March 29, 2029✓✓
- March 29, 2029
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Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Patent 8,653,137
Issued: February 18, 2014
Inventor(s): Jeffs Roger Andrew & Zaccardelli David
Assignee(s): United Therapeutics CorporationBuffer 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✓
- September 5, 2028
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Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Patent 8,658,694
Issued: February 25, 2014
Inventor(s): Jeffs Roger Andrew & Zaccardelli David
Assignee(s): United Therapeutics CorporationBuffer 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✓
- September 5, 2028
-
Compounds and methods for delivery of prostacyclin analogs
Patent 9,199,908
Issued: December 1, 2015
Inventor(s): Phares Ken & Mottola David & Jeffs Roger & Wade Michael
Assignee(s): United Therapeutics CorporationThis 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✓
- May 24, 2024
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Process to prepare treprostinil, the active ingredient in remodulin®
Patent 9,593,066
Issued: March 14, 2017
Inventor(s): Batra Hitesh & Tuladhar Sudersan M. & Penmasta Raju & Walsh David A.
Assignee(s): United Therapeutics CorporationThis 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✓
- December 15, 2028
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Process to prepare treprostinil, the active ingredient in Remodulin®
Patent 9,604,901
Issued: March 28, 2017
Inventor(s): Batra Hitesh & Tuladhar Sudersan M. & Penmasta Raju & Walsh David A.
Assignee(s): United Therapeutics CorporationThis 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✓✓
- December 15, 2028
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Parenteral formulations of treprostinil
Patent 9,713,599
Issued: July 25, 2017
Inventor(s): Wade Michael
Assignee(s): United Therapeutics CorporationThe present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- December 16, 2024✓
- December 16, 2024
More about Remodulin (treprostinil)
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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. |
AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.