LINACLOTIDE - Generic Drug Details
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What are the generic sources for linaclotide and what is the scope of patent protection?
Linaclotide
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Mylan, and Abbvie, and is included in three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Linaclotide has two hundred and nineteen patent family members in forty-four countries.
There are ten drug master file entries for linaclotide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for LINACLOTIDE
International Patents: | 219 |
US Patents: | 12 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 43 |
Patent Applications: | 943 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINACLOTIDE |
What excipients (inactive ingredients) are in LINACLOTIDE? | LINACLOTIDE excipients list |
DailyMed Link: | LINACLOTIDE at DailyMed |
Recent Clinical Trials for LINACLOTIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AbbVie | Phase 2 |
AbbVie | Phase 3 |
Zhiguo Liu | N/A |
Generic filers with tentative approvals for LINACLOTIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 72MCG | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LINACLOTIDE
Drug Class | Guanylate Cyclase-C Agonist |
Mechanism of Action | Guanylate Cyclase Activators |
Paragraph IV (Patent) Challenges for LINACLOTIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LINZESS | Capsules | linaclotide | 72 mcg | 202811 | 1 | 2017-11-07 |
LINZESS | Capsules | linaclotide | 145 mcg and 290 mcg | 202811 | 4 | 2016-08-30 |
US Patents and Regulatory Information for LINACLOTIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LINACLOTIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LINACLOTIDE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AbbVie Deutschland GmbH & Co. KG | Constella | linaclotide | EMEA/H/C/002490 Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults. |
Authorised | no | no | no | 2012-11-26 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LINACLOTIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20220100101 | 경구 투여를 위한 리나클로타이드-함유 제형 (- LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
China | 102020704 | Methods and compositions for the treatment of gastrointestinal disorders | ⤷ Try a Trial |
Croatia | P20200512 | ⤷ Try a Trial | |
Mexico | 2020005326 | FORMULACIONES QUE CONTIENEN LINACLOTIDA PARA ADMINISTRACION ORAL. (LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LINACLOTIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2246360 | PA2013014 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126 |
1594517 | 92200 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUI-CI, PROTEGE PAR LE BREVET DE BASE, Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001-004 20121126 |
1594517 | 466 | Finland | ⤷ Try a Trial | |
1594517 | 2013/023 | Ireland | ⤷ Try a Trial | PRODUCT: LINACLOTIDE AND EVERY THERAPEUTICAL EQUIVALENT FORM THEREOF AS PROTECTED BY THE BASIC PATENT, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS. REGISTRATION NO/DATE IRELAND EU/1/12/801/001, EU/1/12/801/002, EU/1/12/801/003, EU/1/12/801/004 / 26/11/2012 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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