Generic Linzess Availability
Last updated on Nov 6, 2024.
Linzess is a brand name of linaclotide, approved by the FDA in the following formulation(s):
LINZESS (linaclotide - capsule;oral)
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Manufacturer: ABBVIE
Approval date: August 30, 2012
Strength(s): 145MCG [RLD], 290MCG [RLD] -
Manufacturer: ABBVIE
Approval date: January 25, 2017
Strength(s): 72MCG [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: 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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Stable formulations of linaclotide
Patent 10,675,325
Issued: June 9, 2020
Inventor(s): Mo Yun & Fretzen Angelika & Cali Brian & Dedhiya MahendraThe present invention relates to stable pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.
Patent expiration dates:
- August 11, 2031✓
- August 11, 2031
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Stable formulations of linaclotide
Patent 10,702,576
Issued: July 7, 2020
Inventor(s): Mo Yun & Fretzen Angelika & Cali Brian & Dedhiya MahendraThe present invention relates to stable pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.
Patent expiration dates:
- August 11, 2031✓
- August 11, 2031✓
- August 11, 2031
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Patent 7,304,036
Patent expiration dates:
- August 30, 2026✓✓✓
- August 30, 2026✓✓✓
- August 30, 2026✓✓✓
- August 30, 2026
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Patent 7,371,727
Patent expiration dates:
- January 28, 2024✓
- January 28, 2024
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Patent 7,704,947
Patent expiration dates:
- January 28, 2024✓✓
- January 28, 2024
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Patent 7,745,409
Patent expiration dates:
- January 28, 2024✓✓
- January 28, 2024
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Patent 8,080,526
Patent expiration dates:
- January 28, 2024✓✓
- January 28, 2024
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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✓
- January 28, 2024✓
- January 28, 2024✓
- January 28, 2024
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Formulations comprising linaclotide
Patent 8,748,573
Issued: June 10, 2014
Inventor(s): Fretzen Angelika & Witowski Steven & Grossi Alfredo & Zhao Hong & Dedhiya Mahendra & Mo Yun
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:
- October 30, 2031✓
- October 30, 2031✓
- October 30, 2031
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Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Patent 8,802,628
Issued: August 12, 2014
Inventor(s): Fretzen Angelika & Witowski Steven & Grossi Alfredo & Zhao Hong & Dedhiya Mahendra & Mo YunSolid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (“linaclotide”; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.
Patent expiration dates:
- October 30, 2031✓
- October 30, 2031
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Treatments for gastrointestinal disorders
Patent 8,933,030
Issued: January 13, 2015
Inventor(s): Fretzen Angelika & Zhao Hong & Kessler Marco
Assignee(s): Ironwwod Pharmaceuticals, Inc.The present invention features peptides, compositions, and related methods for treating gastrointestinal disorders and conditions, including but not limited to, irritable bowel syndrome (IBS), gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, inflammatory bowel disease, functional heartburn, dyspepsia, visceral pain, gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), disorders and conditions associated with constipation, and other conditions and disorders are described herein, using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Patent expiration dates:
- February 17, 2031✓✓
- February 17, 2031✓✓
- February 17, 2031✓
- February 17, 2031
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Treatments for gastrointestinal disorders
Patent 9,708,371
Issued: July 18, 2017
Inventor(s): Kessler Marco & Fretzen Angelika & Zhao Hong & Solinga Robert & Volchenok Vladimir
Assignee(s): Ironwood Pharmaceuticals, Inc.The present invention features peptides, compositions, and related methods for treating gastrointestinal disorders and conditions, including but not limited to, irritable bowel syndrome (IBS), gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, inflammatory bowel disease, functional heartburn, dyspepsia, visceral pain, gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), disorders and conditions associated with constipation, and other conditions and disorders are described herein, using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Patent expiration dates:
- August 16, 2033✓✓
- August 16, 2033✓✓
- August 16, 2033✓✓
- August 16, 2033
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:
- June 12, 2026 - TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
More about Linzess (linaclotide)
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- Drug class: guanylate cyclase-C agonists
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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.
