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Generic Opsumit Availability

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: 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.

  • 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:
    • October 12, 2022
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      Drug substance
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      Drug product
  • 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
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      Patent use: METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
  • 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
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      Patent use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
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      Drug product
  • 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
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      Patent use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 3% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
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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:
    • October 18, 2018 - NEW CHEMICAL ENTITY
    • October 18, 2020 - ORPHAN DRUG EXCLUSIVITY

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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