Generic Tryvio Availability
Last updated on May 9, 2024.
Tryvio is a brand name of aprocitentan, approved by the FDA in the following formulation(s):
TRYVIO (aprocitentan - tablet;oral)
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Manufacturer: IDORSIA
Approval date: March 19, 2024
Strength(s): 12.5MG [RLD]
Has a generic version of Tryvio been approved?
No. There is currently no therapeutically equivalent version of Tryvio available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tryvio. 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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Patent 10,919,881
Patent expiration dates:
- February 26, 2038✓✓
- February 26, 2038
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Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
Patent 11,174,247
Issued: November 16, 2021
Inventor(s): Bellet Marc & Bolli Martin & Clozel Martine & Iglarz Marc
Assignee(s): IDORSIA PHARMACEUTICALS LTDThe present invention concerns the compound aprocitentan, {5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl}-sulfamide, and its use as endothelin receptor antagonist, in combination with other active ingredients or therapeutic agents including an angiotenin receptor blocker, and/or a calcium channel blocker, and preferably a diuretic which is a thiazide-like diuretic, in the prophylaxis or treatment of certain endothelin related diseases. The invention further relates to pharmaceutical compositions comprising aprocitentan in combination with said other active ingredients or therapeutic agents. The invention further relates to such pharmaceutical compositions comprising novel crystalline forms of aprocitentan.
Patent expiration dates:
- November 6, 2037✓
- November 6, 2037
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Patent 11,680,058
Patent expiration dates:
- July 26, 2038✓
- July 26, 2038
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Patent 11,787,782
Patent expiration dates:
- March 2, 2038✓
- March 2, 2038
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4-pyrimidinesulfamide derivative
Patent 8,324,232
Issued: December 4, 2012
Inventor(s): Bolli Martin & Boss Christoph & Treiber Alexander
Assignee(s): Actelion Pharmaceuticals Ltd.The invention relates to the compound of structural formula (I) and the salts thereof. Said compound is useful as endothelin receptor antagonist. The invention further relates to a process for preparing said compound.
Patent expiration dates:
- September 21, 2029✓✓✓
- September 21, 2029
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:
- March 22, 2029 - NEW CHEMICAL ENTITY
More about Tryvio (aprocitentan)
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Glossary
Term | Definition |
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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.