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, 3 months from now) | Active |
| US7371727 | Methods and compositions for the treatment of gastrointestinal disorders |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US7704947 | Methods and compositions for the treatment of gastrointestinal disorders |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US7745409 | Methods and compositions for the treatment of gastrointestinal disorders |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8080526 | Methods and compositions for the treatment of gastrointestinal disorders |
Jan, 2024
(1 year, 3 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 |
| US8748573 | Formulations comprising linaclotide |
Oct, 2031
(6 years from now) | Active |
| US8802628 | Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration |
Oct, 2031
(6 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
(5 years from now) | Active |
| US8110553 | Methods and compositions for the treatment of gastrointestinal disorders |
Jan, 2024
(1 year, 3 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||
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 |