Linzess Patent Expiration

Linzess is a drug owned by Abbvie Inc. It is protected by 12 US drug patents filed from 2013 to 2020. Out of these, 7 drug patents are active and 5 have expired. Linzess's patents have been open to challenges since 30 August, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 16, 2033. Details of Linzess's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7304036 Methods and compositions for the treatment of gastrointestinal disorders
Aug, 2026

(1 year, 10 months from now)

Active
US7371727 Methods and compositions for the treatment of gastrointestinal disorders
Jan, 2024

(8 months ago)

Expired
US7704947 Methods and compositions for the treatment of gastrointestinal disorders
Jan, 2024

(8 months ago)

Expired
US7745409 Methods and compositions for the treatment of gastrointestinal disorders
Jan, 2024

(8 months ago)

Expired
US8080526 Methods and compositions for the treatment of gastrointestinal disorders
Jan, 2024

(8 months ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9708371 Treatments for gastrointestinal disorders
Aug, 2033

(8 years from now)

Active
US8802628 Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Oct, 2031

(7 years from now)

Active
US8748573 Formulations comprising linaclotide
Oct, 2031

(7 years from now)

Active
US10702576 Stable formulations of linaclotide
Aug, 2031

(6 years from now)

Active
US10675325 Stable formulations of linaclotide
Aug, 2031

(6 years from now)

Active
US8933030 Treatments for gastrointestinal disorders
Feb, 2031

(6 years from now)

Active
US8110553 Methods and compositions for the treatment of gastrointestinal disorders
Jan, 2024

(8 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Linzess's patents.

Given below is the list of recent legal activities going on the following patents of Linzess.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 20 Dec, 2023 US10702576
Payment of Maintenance Fee, 4th Year, Large Entity 22 Nov, 2023 US10675325
Payment of Maintenance Fee, 12th Year, Large Entity 26 Jul, 2023 US8110553
Payment of Maintenance Fee, 12th Year, Large Entity 10 May, 2023 US8080526 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 29 Jun, 2022 US8933030 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 26 Jan, 2022 US8802628 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 11 Nov, 2021 US7745409
Payment of Maintenance Fee, 12th Year, Large Entity 09 Sep, 2021 US7704947 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 06 Jan, 2021 US9708371
Patent Issue Date Used in PTA Calculation 07 Jul, 2020 US10702576


FDA has granted several exclusivities to Linzess. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Linzess, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Linzess.

Exclusivity Information

Linzess holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Linzess's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 30, 2017
New Strength(NS) Jan 25, 2020
New Indication(I-921) Jun 12, 2026

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Several oppositions have been filed on Linzess's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Linzess's generic, the next section provides detailed information on ongoing and past EP oppositions related to Linzess patents.

Linzess's Oppositions Filed in EPO

Linzess has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 26, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP10170038A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP12753313A Sep, 2017 Hexal AG Revoked
EP10170038A Mar, 2013 Generics [UK] Limited Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Linzess is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Linzess's family patents as well as insights into ongoing legal events on those patents.

Linzess's Family Patents

Linzess has patent protection in a total of 42 countries. It's US patent count contributes only to 32.2% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Linzess.

Family Patents

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Generic Launch

Generic Release Date:

Linzess's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 16, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Linzess Generics:

Linaclotide is the generic name for the brand Linzess. 2 different companies have already filed for the generic of Linzess, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Linzess's generic

How can I launch a generic of Linzess before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Linzess's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Linzess's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Linzess -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
145 mcg and 290 mcg 30 Aug, 2016 4 09 Feb, 2021 30 Oct, 2031 Deferred
72 mcg 07 Nov, 2017 1 16 Aug, 2033

Alternative Brands for Linzess

Linzess which is used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, and functional constipation in pediatric patients., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Braintree Labs
Pizensy Used for treating chronic idiopathic constipation in adult patients.





About Linzess

Linzess is a drug owned by Abbvie Inc. It is used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, and functional constipation in pediatric patients. Linzess uses Linaclotide as an active ingredient. Linzess was launched by Abbvie in 2017.

Can you believe Linzess received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Approval Date:

Linzess was approved by FDA for market use on 25 January, 2017.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Linzess is 25 January, 2017, its NCE-1 date is estimated to be 30 August, 2016.

Active Ingredient:

Linzess uses Linaclotide as the active ingredient. Check out other Drugs and Companies using Linaclotide ingredient

Treatment:

Linzess is used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, and functional constipation in pediatric patients.

Dosage:

Linzess is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
290MCG CAPSULE Prescription ORAL
145MCG CAPSULE Prescription ORAL
72MCG CAPSULE Prescription ORAL


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