Skip to content

Are linaclotide and Linzess the same? Understanding Brand vs. Generic Medication

4 min read

Over 2 million prescriptions for Linzess were filled in the U.S. in 2023, making it a highly common medication. For those prescribed this treatment, a common question arises: Are linaclotide and Linzess are the same? The short answer is yes, with one referring to the active ingredient and the other to the brand-name product.

Quick Summary

Linaclotide is the active chemical component in the brand-name medication Linzess. Both names refer to the same prescription treatment for chronic constipation and irritable bowel syndrome with constipation (IBS-C), but linaclotide is not yet available as a lower-cost generic product in the U.S..

Key Points

  • Active Ingredient: Linaclotide is the active ingredient in the brand-name drug Linzess.

  • Brand vs. Generic: Linzess is the proprietary brand name, whereas linaclotide is the generic, chemical name.

  • Not Yet Generic (U.S.): As of early 2025, there is no generic version of linaclotide available for purchase in the United States.

  • Delayed Release: Generic linaclotide is expected to be available after March 2029 due to a patent settlement agreement.

  • Identical Function: Both the brand-name Linzess and the future generic linaclotide are bioequivalent and will work identically to treat conditions like IBS-C and CIC.

  • Cost Difference: Once available, the generic version is expected to be significantly more affordable than the brand-name version.

  • Dosage and Formulation: Dosage strengths and overall formulations (e.g., capsule) will be the same for the brand and its future generic equivalent.

In This Article

Before taking any medication, including Linzess, it is important to consult with a healthcare professional to determine the appropriate treatment and dosage for your specific condition. The information provided here is for general knowledge and should not be considered medical advice.

What is Linaclotide? The Active Ingredient Explained

Linaclotide is the official, or generic, name for the active chemical ingredient found in the prescription medication Linzess. It is a guanylate cyclase-C (GC-C) agonist, a class of drugs that works directly in the intestinal tract to increase fluid secretion. Linaclotide is minimally absorbed into the bloodstream, meaning it acts locally in the gastrointestinal (GI) tract to produce its effects.

The pharmacological action of linaclotide involves binding to the GC-C receptor on the surface of intestinal cells. This triggers a cascade that increases the level of cyclic guanosine monophosphate (cGMP), ultimately stimulating the secretion of chloride and bicarbonate into the intestinal lumen. This increased fluid softens the stool and accelerates bowel transit, helping to alleviate constipation and associated abdominal pain in certain conditions.

What is Linzess? The Brand-Name Medication

Linzess is the specific, copyrighted brand name given to the medication that contains linaclotide. Manufactured by AbbVie in the United States in partnership with Ironwood Pharmaceuticals, Linzess is the proprietary product that has been marketed and sold since its FDA approval in 2012. The brand name is what patients see on the prescription bottle and is the version initially available exclusively on the market due to patent protection. In other countries, the brand name for the same medication is Constella.

Brand vs. Generic: Why the Names Matter

While the names refer to the same active medication, understanding the brand-generic distinction is critical for patients, particularly regarding cost and availability. Here are the key differences:

  • Active vs. Inactive Ingredients: By law, a generic drug must contain the same active ingredient as its brand-name counterpart. However, inactive ingredients—such as fillers, binders, and flavorings—can vary. This difference is largely cosmetic and does not affect the medication's effectiveness or safety profile.
  • Efficacy and Bioequivalence: The U.S. Food and Drug Administration (FDA) requires that generic medications be 'bioequivalent' to the brand-name version, meaning they must work in the same way and provide the same clinical benefit. For linaclotide, this means both versions will produce the same increase in intestinal fluid and transit time.
  • Cost: Once a brand-name drug's patent expires, other companies can manufacture and sell a generic version. Generic drugs typically cost significantly less than their brand-name counterparts because the generic manufacturers do not bear the initial research and development costs. This is the primary reason patients often switch to a generic when available.
  • Timeline and Availability: As of late 2025, there is no generic version of linaclotide commercially available in the U.S. due to patent protection. However, pharmaceutical agreements have been reached for a generic version of linaclotide to potentially enter the U.S. market after March 31, 2029.

A Side-by-Side Comparison: Linaclotide vs. Linzess

Feature Linaclotide (Generic Name) Linzess (Brand Name)
Active Ingredient Linaclotide Linaclotide
Manufacturer Manufactured by various companies after patent expiry (e.g., Teva post-2029). Marketed by AbbVie (and originally Ironwood Pharmaceuticals).
Availability (U.S.) Not yet commercially available due to patent. Widely available as a prescription medication.
Cost Will likely be lower-cost once available. Typically more expensive, though manufacturer savings programs may exist.
Inactive Ingredients Can vary from the brand-name product. Specific, proprietary inactive ingredients.
Prescription Status Requires a prescription. Requires a prescription.
Efficacy Bioequivalent to the brand name; same clinical effect. Same clinical effect as the generic version.

The Future of Linaclotide and Linzess

For patients currently taking Linzess, the eventual release of a generic linaclotide will offer a more affordable treatment option. The introduction of generic versions typically drives down costs for consumers and the healthcare system as a whole. A key step towards this was a settlement agreement that granted Teva a license to market its generic version of linaclotide starting in 2029.

For individuals with health insurance, the availability of a generic version may lead to lower co-pays, provided their plan covers the generic. In many cases, pharmacists are able to automatically substitute a brand-name prescription with an FDA-approved generic unless the physician specifies otherwise.

Conclusion

To put it simply, linaclotide and Linzess are the same in terms of their core medicinal purpose and active component. Linaclotide is the generic name for the active drug, while Linzess is the brand name under which it is marketed. While the two are medically equivalent, differences in inactive ingredients and, most importantly, cost and availability set them apart. As of late 2025, only the brand-name Linzess is available in the U.S., but a lower-cost generic is expected to become available in the coming years, following patent expiration.

For further information on generic drugs, a resource is available from the U.S. Food and Drug Administration: https://www.fda.gov/drugs/generic-drugs-questions-answers.

Frequently Asked Questions

Linaclotide is the generic name for the active ingredient, while Linzess is the brand name for the medication containing that ingredient. They are medically identical, providing the same treatment effects.

As of late 2025, a generic version of Linzess (linaclotide) is not yet commercially available in the United States due to ongoing patent protection. Patent settlements indicate a generic may be available after March 2029.

The primary reason to switch would be cost. Generic versions are typically much less expensive than brand-name drugs because the manufacturer did not incur the original research and development costs. The clinical benefits would remain the same.

Linzess (linaclotide) is a prescription medication used to treat Irritable Bowel Syndrome with Constipation (IBS-C), Chronic Idiopathic Constipation (CIC) in adults, and Functional Constipation (FC) in pediatric patients aged 6 to 17.

As a guanylate cyclase-C (GC-C) agonist, the medication works by increasing the fluid in your intestines and accelerating transit. This helps soften stools and leads to more regular bowel movements.

Yes. Since the generic version must contain the exact same active ingredient and be bioequivalent, the side effect profile is expected to be the same. The most common side effect is diarrhea, which can sometimes be severe.

No. Linzess (linaclotide) is a prescription-only medication and cannot be purchased over-the-counter. It requires a prescription from a licensed healthcare provider.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.