Generic Opsumit Availability
Last updated on Jan 11, 2023.
Opsumit is a brand name of macitentan, approved by the FDA in the following formulation(s):
OPSUMIT (macitentan - tablet;oral)
Has a generic version of Opsumit been approved?
No. There is currently no therapeutically equivalent version of Opsumit available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Opsumit. 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 10,946,015
Patent expiration dates:
- September 11, 2026✓✓
- September 11, 2026
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Sulfamides and their use as endothelin receptor antagonists
Patent 7,094,781
Issued: August 22, 2006
Inventor(s): Bolli; Martin & Boss; Christoph & Fischli; Walter & Clozel; Martine & Weller; Thomas
Assignee(s): Actelion Pharmaceuticals Ltd.The invention relates to novel sulfamides and their use as active ingredients in the preparation of pharmaceutical compositions. The invention also concerns related aspects including processes for the preparation of the compounds, pharmaceutical compositions containing one or more of those compounds and especially their use as endothelin receptor antagonists.
Patent expiration dates:
- December 5, 2025✓✓
- December 5, 2025
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Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Patent 8,268,847
Issued: September 18, 2012
Inventor(s): Clozel; Martine
Assignee(s): Actelion Pharmaceuticals, Ltd.The invention relates to a product containing the compound of formula (I) below or a pharmaceutically acceptable salt of this compound, in combination with at least one compound having PDE5-inhibitory properties, or a pharmaceutically acceptable salt thereof, for therapeutic use, simultaneously, separately or over a period of time, in the treatment of a disease wherein vasoconstriction is involved.
Patent expiration dates:
- April 18, 2029✓
- April 18, 2029
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Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent 8,367,685
Issued: February 5, 2013
Assignee(s): Actelion Pharmaceuticals, Ltd.Stable pharmaceutical compositions include the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof:
Patent expiration dates:
- October 4, 2028✓✓
- October 4, 2028
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Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent 9,265,762
Issued: February 23, 2016
Assignee(s): ACTELION PHARMACEUTICALS LTD.The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof.
Patent expiration dates:
- May 29, 2027✓✓
- May 29, 2027
More about Opsumit (macitentan)
- Check interactions
- Pricing & coupons
- Reviews (8)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: agents for pulmonary hypertension
- En español
Patient resources
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Related treatment guides
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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.