When will generic linzess be available?

Patent Expiration and Generic Availability Timeline

Linzess, also known as linaclotide, is a medication used to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation in adults. The patent for Linzess was granted to Ironwood Pharmaceuticals and Valeant Pharmaceuticals International (now Bausch Health Companies Inc.). [1]

Current Patent Status

According to DrugPatentWatch.com [2], the patent for Linzess, specifically the US Patent No. 9,145,863, is expected to expire on May 23, 2038. However, patent challenges and settlements can extend or abbreviate this timeline.

Generic Availability Expectations

Generic or biosimilar versions of Linzess will likely enter the market after the patent expires. Pharmaceutical companies like Teva Pharmaceuticals and Mylan N.V., among others, have already started generic versions of the medication in various stages of development.

Biosimilar Entry and Patent Exclusivity

While biosimilars cannot enter the market until after the patent has expired, it is not uncommon for biosimilar companies to initiate entry before exclusivity expiry. [3] Companies may seek regulatory approval earlier to secure a first-to-market advantage or mitigate patent litigation risks.

Timeline Risks and Uncertainties

The actual availability timeline may be affected by factors like patent litigation, settlements, or potential reissues of the patent. Any changes to the patent's expiration date could influence the commercial availability of generic Linzess.

Regulatory Approval Process

Before entering the market, generic or biosimilar companies will need to obtain approval from regulatory agencies like the US FDA. This process typically involves submitting a Biologics License Application (BLA) for biosimilars or an Abbreviated New Drug Application (ANDA) for generics.

Patient Access and Pricing

Generic and biosimilar entry will likely lead to increased competition and lower prices for Linzess. Patients can expect to benefit from these market dynamics, although specific pricing and access conditions may vary based on insurance coverage, reimbursement policies, and local market conditions.

References

[1] Ironwood Pharmaceuticals and Valeant Pharmaceuticals International (now Bausch Health Companies Inc.): United States Patent No. 9,145,863.

[2] DrugPatentWatch.com. https://drugpatentwatch.com/

[3] FDA, "Biologics and Biosimilars," accessed March 2023, https://www.fda.gov/drugs/biologics-and-biosimilars/biologics-biosimilars