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Generic Adempas Availability

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

ADEMPAS (riociguat - tablet;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: October 8, 2013
    Strength(s): 0.5MG, 1MG, 1.5MG, 2MG, 2.5MG [RLD]

Has a generic version of Adempas been approved?

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

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

  • Substituted pyrazole derivatives condensed with six-membered heterocyclic rings
    Patent 6,743,798
    Issued: June 1, 2004
    Inventor(s): Alexander; Straub & Achim; Feurer & Cristina; Alonso-Alija & Johannes-Peter; Stasch & Elisabeth; Perzborn & Joachim; Hütter & Klaus; Dembowsky & Elke; Stahl
    Assignee(s): Bayer Aktiengesellschaft
    The present invention relates to novel substituted pyrazole derivatives of the general formula (I) in which R1, R2, R3 and A are each as defined, and to processes for their preparation and to their use as medicaments, in particular as medicaments for the treatment of cardiovascular disorders.
    Patent expiration dates:
    • July 16, 2019
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  • Carbamate-substituted pyrazolopyridines
    Patent 7,173,037
    Issued: February 6, 2007
    Inventor(s): Alonso-Alija; Cristina & Bischoff; Erwin & Münter; Klaus & Stasch; Johannes-Peter & Stahl; Elke & Weigand; Stefan & Feurer; Achim
    Assignee(s): Bayer HealthCare AG
    The present invention relates to compounds which stimulate soluble guanylate cyclase, to the preparation thereof and to the use thereof as medicaments, in particular as medicaments for the treatment of cardiovascular disorders and/or sexual dysfunction.
    Patent expiration dates:
    • April 25, 2023
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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 8, 2018 - NEW CHEMICAL ENTITY
    • October 8, 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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