Medication Guide App

Generic Linzess Availability

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

LINZESS (linaclotide - capsule;oral)

  • Manufacturer: FOREST LABS INC
    Approval date: August 30, 2012
    Strength(s): 145MCG, 290MCG [RLD]

Has a generic version of Linzess been approved?

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

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

  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 7,304,036
    Issued: December 4, 2007
    Inventor(s): Currie; Mark G. & Mahajan-Miklos; Shalina & Norman; Thea & Milne; G. Todd
    Assignee(s): Microbia, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Patent use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
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      Drug substance
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      Drug product
  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 7,371,727
    Issued: May 13, 2008
    Inventor(s): Currie; Mark G. & Mahajan-Miklos; Shalina & Fretzen; Angelika & Sun; Li Jing & Norman; Thea & Milne; G. Todd
    Assignee(s): Microbia, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Drug substance
  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 7,704,947
    Issued: April 27, 2010
    Inventor(s): Currie; Mark G. & Mahajan-Miklos; Shalina & Norman; Thea & Milne; G. Todd
    Assignee(s): Ironwood Pharmaceuticals, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation, and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 7,745,409
    Issued: June 29, 2010
    Inventor(s): Currie; Mark G. & Mahajan-Miklos; Shalina & Norman; Thea & Milne; G. Todd
    Assignee(s): Ironwood Pharmaceuticals, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 8,080,526
    Issued: December 20, 2011
    Inventor(s): Currie; Mark & Mahajan-Miklos; Shalina & Milne; G. Todd & Norman; Thea
    Assignee(s): Ironwood Pharmaceuticals, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation, and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods and compositions for the treatment of gastrointestinal disorders
    Patent 8,110,553
    Issued: February 7, 2012
    Inventor(s): Currie; Mark G. & Mahajan-Miklos; Shalina & Milne; G. Todd & Norman; Thea
    Assignee(s): Ironwood Pharmaceuticals, Inc.
    The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
    Patent expiration dates:
    • January 28, 2024
      ✓ 
      Patent use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
  • Formulations comprising linaclotide
    Patent 8,748,573
    Issued: June 10, 2014
    Assignee(s): Ironwood Pharmaceuticals, Inc.
    The present invention relates to stable compositions comprising linaclotide, as well as to various methods and processes for the preparation and use of the compositions.
    Patent expiration dates:
    • June 20, 2031
      ✓ 
      Patent use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
    • June 20, 2031
      ✓ 
      Patent use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.

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:
    • August 30, 2017 -

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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