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Generic Fulyzaq Availability

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

FULYZAQ (crofelemer - tablet, delayed release;oral)

  • Manufacturer: NAPO PHARMS INC
    Approval date: December 31, 2012
    Strength(s): 125MG [RLD]

Has a generic version of Fulyzaq been approved?

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

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

  • Enteric formulations of proanthocyanidin polymer antidiarrheal compositions
    Patent 7,323,195
    Issued: January 29, 2008
    Inventor(s): Rozhon; Edward James & Khandwala; Atul S. & Sabouni; Akram & Balwani; Gul P. & Chan; Jody Wai-Han & Sesin; David F.
    Assignee(s): Napo Pharmaceuticals, Inc.
    Pharmaceutical compositions containing a proanthocyanidin polymer composition which are useful for the treatment and prevention of secretory diarrhea are provided. The invention specifically relates to pharmaceutical formulations of a proanthocyanidin polymer composition which has been isolated from a Croton spp. or a Calophyllum spp. In particular, the invention relates to a formulation of a proanthocyanidin polymer composition which protects the composition from the effects of stomach acid after oral administration, particularly to those formulations which are enteric coated. The invention also relates to methods of producing a directly compressible proanthocyanidin polymer composition, as well as compositions containing the directly compressible proanthocyanidin polymer composition.
    Patent expiration dates:
    • June 7, 2018
      ✓ 
      Drug product
  • Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer
    Patent 7,341,744
    Issued: March 11, 2008
    Inventor(s): Rozhon; Edward James & Khandwala; Atul S. & Sabouni; Akram & Balwani; Gul P. & Chan; Jody Wai-Han & Sesin; David F.
    Assignee(s): Napo Pharmaceuticals, Inc.
    Pharmaceutical compositions containing a proanthocyanidin polymer composition which are useful for the treatment and prevention of secretory diarrhea are provided. The invention specifically relates to pharmaceutical formulations of a proanthocyanidin polymer composition which has been isolated from a Croton spp. or a Calophyllum spp. In particular, the invention relates to a formulation of a proanthocyanidin polymer composition which protects the composition from the effects of stomach acid after oral administration, particularly to those formulations which are enteric coated. The invention also relates to methods of producing a directly compressible proanthocyanidin polymer composition, as well as compositions containing the directly compressible proanthocyanidin polymer composition.
    Patent expiration dates:
    • June 16, 2018
      ✓ 
      Patent use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
  • Compositions and methods of treatment with proanthocyanidin polymer antidiarrheal compositions
    Patent 8,574,634
    Issued: November 5, 2013
    Assignee(s): Napo Pharmaceutcials, Inc.
    Pharmaceutical compositions containing a proanthocyanidin polymer composition which are useful for the treatment and prevention of secretory diarrhea are provided. The invention specifically relates to pharmaceutical formulations of a proanthocyanidin polymer composition which has been isolated from a Croton spp. or a Calophyllum spp. In particular, the invention relates to a formulation of a proanthocyanidin polymer composition which protects the composition from the effects of stomach acid after oral administration, particularly to those formulations which are enteric coated. The invention also relates to methods of producing a directly compressible proanthocyanidin polymer composition, as well as compositions containing the directly compressible proanthocyanidin polymer composition.
    Patent expiration dates:
    • January 11, 2018
      ✓ 
      Patent use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
  • Methods and compositions for treating HIV-associated diarrhea
    Patent 8,962,680
    Issued: February 24, 2015
    Assignee(s): Salix Pharmaceuticals, Ltd. Napo Pharmaceuticals, Inc.
    Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
    Patent expiration dates:
    • October 31, 2031
      ✓ 
      Patent use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA

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:
    • December 31, 2017 - NEW CHEMICAL ENTITY

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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