Is there a generic for Linzess? Availability, timeline, and cost

In this article:

• Generic Linzess
• Generic vs. brand-name Linzess
• Generic Linzess cost
• Off-label uses
• Does insurance cover Linzess?
• How to get coverage
• Alternatives
• How to switch
• Long-term use

In this article

• Generic Linzess
• Generic vs. brand-name Linzess
• Generic Linzess cost
• Off-label uses
• Does insurance cover Linzess?
• How to get coverage
• Alternatives
• How to switch
• Long-term use

Linzess is a brand-name medication that contains linaclotide as its active ingredient. It was FDA-approved in 2012 to treat chronic constipation and irritable bowel syndrome with constipation (IBS-C), and it works by increasing intestinal fluid and speeding up bowel movements. There’s no generic version of Linzess currently available, and one won’t be available until at least March 2029 based on patent agreements.

Is there a generic for Linzess?

As mentioned, the generic form of Linzess isn’t available yet, so you’ll have to stick with the brand name. That shouldn’t create a problem, doctors say. “Linzess has been very available to my patients, [in terms of insurance coverage]” Dr. Khapra says. More good news: The generic version may be coming.

“According to my research, pursuant to the terms of a settlement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg version of Linzess in the United States beginning March 31, 2029,” says Dr. David Clarke, MD, a doctor who’s board-certified in internal medicine and gastroenterology and the president of the Association for Treatment of Neuroplastic Symptoms.

Essentially, Linzess (and Constella) are the intellectual property and trademarks of Ironwood Pharmaceuticals, so their “permission” is needed to make a generic version.

The generic may be referred to by Linzess’s active ingredient: linaclotide. Linzess contains linaclotide-coated beads in hard gelatin capsules. It belongs to the guanylate cyclase-C agonist (GC-C) drug class. This class of medications is known for treating chronic constipation.

What are the differences between generic vs. brand-name Linzess?

The brand-name version (and eventual generic version) of this prescription drug is largely the same, so you’d experience similar therapeutic effects. 

However, it’s worth noting that brand-name drugs—while more expensive—may at times lead to more positive results than generic drugs, according to some studies. That’s one reason people may opt for the brand name even when the generic comes out.

Research backs up the benefits of brand-name medications. A 2020 study in the International Journal of Neuropsychopharmacology found that brand-name antidepressants outperform their generic counterparts, at least when it comes to preventing hospitalization. 

In addition, a 2017 study in Circulation: Cardiovascular Quality and Outcomes found that patients who took generic versions of blood pressure medications experienced increased rates of side effects.

Whether that goes for any given drug is unclear, but per usual, the best bet is to talk through options with a prescribing doctor.

Linzess is taken by mouth and comes in white, cream, or gray capsules. As for dosage, Linzess comes in 72 mcg, 145 mcg, or 290 mcg capsules, depending on the patient’s age and condition (see the chart below). 

How much does generic Linzess cost?

Linzess is only available as a brand-name drug, which means that it can come with higher prices than generic medications. For a 30-day supply of 145 mcg capsules of Linzess without insurance, the average cost is around $718.

The cost will depend on factors such as insurance coverage, dosage, and the quantity prescribed. In addition, the pharmacy and location can influence costs. Without insurance, the cost of Linzess could be reduced with a prescription discount card. A SingleCare card could reduce the retail price to around $252 for 30, 145 mcg capsules.

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What are the off-label uses for Linzess?

Chronic idiopathic constipation isn’t the only reason people may buy Linzess; the medicine has other possible uses. For example, while it’s typically given to patients with IBS-C or functional constipation, Dr. Khapra says healthcare providers may prescribe it to patients with general constipation symptoms, regardless of the cause.

“Of course, you cannot use it if patients have an active obstruction,” she adds. (When there’s an intestinal obstruction in the GI tract, a constipation medication could worsen the issue.)

Some patients have also misused linaclotide, particularly those who want to lose weight or have eating disorders and are using the medication as a laxative. “However, this use is not recommended, and [Linzess] is considered contraindicated in patients with inflammatory bowel disease (IBD) or mechanical bowel obstruction (MBO),” Dr. Clarke says.

Does insurance cover Linzess?

Linzess is often covered by commercial insurance and Medicare prescription drug plans. However, actual coverage may vary from plan to plan. In addition, having insurance coverage doesn’t mean the drug is more affordable.

Even if Linzess is covered by insurance, you may be responsible for a copay or coinsurance amount. Whether you’ve met your plan’s deductible can also play into the cost you’ll pay at the pharmacy. It’s always best to consult your insurance provider or pharmacy for more information on the cost.

For those without insurance, Linzess can be costly as a brand-name drug. However, patient assistance programs, manufacturer savings cards, and prescription discount cards may lower the cost.

How do you get Linzess covered by insurance?

If Linzess isn’t covered, you may want to verify your coverage details or contact your insurance provider to see why. They might require prior authorization, which means your doctor or healthcare provider will have to send documentation of your medical history, overall condition, and why Linzess is medically necessary. 

Some insurance plans may require step therapy, or trying other generic, lower-cost alternatives, before covering Linzess. After trying a different medication and showing it didn’t work as well or caused intolerable side effects, insurance may then offer coverage for a drug like Linzess. Even after a denied claim, you can always file an appeal with help from your healthcare provider.

Generic alternatives to Linzess

If Linzess isn’t the best choice because of cost, side effects, or another reason, you may be recommended an alternative. Other medications are available to treat chronic constipation and may also be available in generic versions, which may be more accessible.

Alternatives to Linzess include:

• Amitiza (lubiprostone) 
• Motegrity (prucalopride succinate) 
• Lactulose 

• Trulance (plecanatide)
• Ibsrela (tenapanor) 

Amitiza and Motegrity are alternatives to Linzess that are available in generic forms. Still, you’ll want to consult a healthcare provider to determine the most appropriate treatment based on your overall condition. 

How to switch from Linzess to linaclotide

Linzess-treated patients may want to switch to the generic when it becomes available. Thankfully, it should be easy to do so safely. Patients don’t need to worry about tapering or withdrawal effects with Linzess (though stopping it abruptly may lead to the return of constipation).

“When switching, there is no need to do anything different,” Dr. Khapra says. “You can stop Linzess one day and start the linaclotide the following day.”

That’s because the two medications are identical, Dr. Clarke says. If you miss a dose, just skip it and take your next dose at the regular time.

Other good-to-know information from these gastroenterology doctors:

• There isn’t usually a specific need or medical condition in which a provider would want a patient to take a brand-name over a generic. At the same time, a clinician may prefer prescribing a brand-name drug because of its “established efficacy and safety profile documented in clinical trials,” as well as the fact that brand-name medications “often come with patient support programs,” according to Dr. Clarke.
• If the prescription says “brand medically necessary,” the pharmacist must give the brand name. Otherwise, they can switch to the generic if the generic is available. It just depends on state laws and insurance policies.
• If a patient doesn’t keep up with the daily dosage or there’s a shortage, they won’t experience any withdrawal symptoms, per se; however, constipation will quickly return. But again, that’s a resumption of previous symptoms, not “withdrawal.”

Long-term use of Linzess 

Linzess can be taken long-term. “Linzess is designed for long-term use, provided it remains effective and well-tolerated by the patient,” Dr. Clarke says. “There is no evidence of diminished response over time, making it suitable for extended treatment.”

Some long-term side effects people may face, he adds, include diarrhea, bloating, and abdominal pain. Dr. Khapra agrees that the medication is safe long-term and that it’s meant to be taken as a maintenance medication.

Last but not least, it’s important to note that this health information is only for educational purposes; it doesn’t replace the individualized expertise of a licensed healthcare provider or doctor. Talking to a medical professional who knows your history is a paramount first step.