Is Linzess generic available?

Linzess (linaclotide) is an expensive brand-name drug that currently has no generic version available. There are deals in place with its manufacturer for Mylan, Teva, and Sandoz to make generic versions of Linzess starting in 2029 and 2030.

Learn more about the earliest possible date for generic Linzess and options to save money on this medication.

What is Linzess (linaclotide)?

Linzess is a prescription medication that is manufactured through a partnership between Allergan and Ironwood Pharmaceuticals, Inc. It was initially approved by the United States Food and Drug Administration (FDA) in 2012 to treat:

• Irritable bowel syndrome with constipation (IBS-C)
• Chronic idiopathic constipation (CIC)

Linzess is classified as a guanylate cyclase-C agonist (GC-C agonist). It binds to the GC-C receptor within the intestinal epithelium, which increases the fluid in your intestines. This moves food and waste through your gastrointestinal (GI) transit to increase bowel movements and relieve chronic constipation. In animal studies, Linzess also reduced stomach pain.

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What dosage forms and strengths of Linzess are available?

Linzess is available as an oral capsule in strengths of 72 mcg, 145 mcg, and 290 mcg.

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Are there cheaper alternatives to Linzess?

There are other FDA-approved prescription medications your healthcare provider can prescribe for you if you cannot take Linzess. These medications have different strengths, dosages, and indications.

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What drug is comparable to Linzess?

If Linzess does not work for you, Trulance (plecanatide) is another medication that belongs to the same drug class as Linzess. If you can’t take Linzess because you had serious adverse effects such as an allergic reaction, you should not take Trulance as you could have the same reaction. Trulance is an oral tablet you typically take once a day to treat IBS-C and CIC. It is contraindicated in patients under 6 years of age and should be avoided in patients under 18 years of age. Trulance’s main side effect is diarrhea. Like Linzess, there is no generic drug alternative available for it. The cost of Trulance without insurance is around $575, which is comparable to Linzess. Talk with your healthcare professional to find out if Trulance could be the right medication for you.

Is there a generic version of Linzess (linaclotide)?

No, there is currently no generic available for Linzess.

Allergan and Ironwood Pharmaceuticals have agreed to license generic versions of Linzess starting in 2029. Teva has a license to market generic Linzess in strengths of 145 mcg and 290 mcg in the United States starting March 31, 2029. Their agreement does not include the 72 mcg strength. Sandoz also reached a settlement to market its generic version of the 145 mcg and 290 mcg strengths in the U.S. starting in February of 2030. Mylan can begin producing its generic version in strengths of 145 mcg and 290 mcg in the U.S. starting February 5, 2030, and 72 mcg starting August 5, 2030. These are all subject to approval by the FDA.

When will the patent for Linzess expire?

The patent for Linzess will expire on August 11, 2031. However, the manufacturer has agreed with multiple generic companies to start producing generic Linzess starting March 31, 2029.

How do you take Linzess?

• Take Linzess exactly as your healthcare provider prescribes it to you. Do not change your dose or stop taking this medication without discussing it with them first.
• Linzess is typically taken once a day on an empty stomach, at least 30 minutes before the first meal of the day.
• If you miss a dose of Linzess, skip the missed dose and take your next dose at the scheduled time. Do not take extra doses or 2 doses at the same time to make up for a missed dose.
• You should swallow the Linzess capsule whole without crushing or chewing them. If you have problems swallowing Linzess capsules whole, you can open the capsule and sprinkle the beads over room-temperature applesauce. You can also mix Linzess beads with bottled water. You should swallow the mixture completely without chewing. You need to wait at least 30 minutes before eating if you take Linzess mixed with applesauce or water.

What should you tell your doctor before starting Linzess?

You should not take Linzess if you have had an allergic reaction to lubiprostone or any of the inactive ingredients in its formulation. You should also avoid this medication if you have a GI obstruction. Make sure your doctor is also aware if you are pregnant, plan on becoming pregnant, or are breastfeeding.

Linzess side effects

The most common side effects of Linzess seen in clinical trials include:

• Diarrhea
• Abdominal pain
• Flatulence (gas)
• Bloating
• Headache
• Vomiting
• Upper respiratory tract infection
• Sinusitis

Linzess can sometimes cause serious side effects such as:

• Severe hypersensitivity reactions, including hives, swelling of your throat or tongue, and shortness of breath
• Severe diarrhea, which can lead to serious dehydration

Speak with your prescribing doctor about the possible drug interactions with any other prescription drugs, over-the-counter products, supplements and vitamins you are taking. These are not all of the possible side effects of Linzess. You should always seek medical advice for any questions or concerns relating to your medical condition or treatment. You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Is Linzess dangerous?

Linzess is typically well tolerated and safe when taken as prescribed. However, it can cause some serious adverse effects. The use of Linzess in animal studies led to severe dehydration and death in some babies. For that reason, Linzess should be avoided in children 2 years of age and younger. Linzess can also cause severe diarrhea, which can lead to life-threatening dehydration. You should be sure to drink plenty of fluids while taking Linzess to help reduce your risk of dehydration. Stop using this medication and seek immediate medical attention if you develop abdominal pain, severe diarrhea, fainting, or bright red or black tar stool.

What is the price of Linzess?

Linzess is an expensive medication that has no generic version available. If you have prescription drug insurance, the cost of Linzess may vary depending on the coverage provided by your healthcare plan. To find out what you may need to pay, your insurance provider or pharmacist should be able to calculate your copay with your current insurance. The average retail price of Linzess without insurance is over $580.

How much does Linzess cost at Walmart?

The average 12-month retail price of Linzess at Walmart is $557 without insurance.

Why is Linzess so expensive?

With no generic available, Linzess has no competition to help lower the price. Once approved by the FDA, generic drugs typically cost about 80% to 85% less than their branded drugs.

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Is Linzess covered by insurance?

According to the pharmaceutical manufacturer, 82% of patients are not required to take an OTC medication before receiving Linzess. It is considered a preferred or covered brand in 10 out of 10 top commercial insurance plans and 7 out of 7 top Medicare Part D plans.

Is Linzess available over the counter?

No, Linzess is not available over the counter and will require a prescription from your doctor. There are several laxatives that you can get over the counter before seeing your doctor if you have constipation, including Miralax (polyethylene glycol), Dulcolax (bisacodyl), and Senokot (senna).