Linaclotide - Generic Drug Details
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What are the generic drug sources for linaclotide and what is the scope of freedom to operate?
Linaclotide
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Mylan, and Abbvie, and is included in three NDAs. There are seven 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 eighteen patent family members in forty-five 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: | 218 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 44 |
Patent Applications: | 777 |
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 |
---|---|
Jinling Hospital, China | N/A |
AbbVie | Phase 2 |
AbbVie | Phase 3 |
Generic filers with tentative approvals for LINACLOTIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for linaclotide
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
Expired US Patents for linaclotide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Try for Free | ⤷ Try for Free |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Try for Free | ⤷ Try for Free |
>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 |
---|---|---|---|
Eurasian Patent Organization | 201290799 | ЛЕЧЕНИЕ ЖЕЛУДОЧНО-КИШЕЧНЫХ РАССТРОЙСТВ | ⤷ Try for Free |
Israel | 211028 | תכשירים רוקחיים מוצקים המכילים לינקלוטידין, קטיון ואמין ראשוני בעל הפרעה סטרית ושימושם להכנת תרופה לטיפול במחלות במערכת העיכול (Solid pharmaceutical compositions comprising linaclotide, a cation and a sterically hindered primary amine and use thereof in the preparation of medicaments for treating gastrointestinal disorders) | ⤷ Try for Free |
South Africa | 200607433 | Methods and compositions for the treatment of gastroin-testinal disorders | ⤷ Try for Free |
South Korea | 20230025926 | 경구 투여를 위한 리나클로타이드-함유 제형 (- LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2012021715 | ⤷ Try for Free | |
Russian Federation | 2433133 | ПОЛИПЕПТИД ДЛЯ УВЕЛИЧЕНИЯ АКТИВНОСТИ РЕЦЕПТОРА ГУАНИЛАТЦИКЛАЗЫ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СПОСОБ ЛЕЧЕНИЯ ЖЕЛУДОЧНО-КИШЕЧНОГО РАССТРОЙСТВА У ПАЦИЕНТА, СПОСОБ ПОВЫШЕНИЯ АКТИВНОСТИ РЕЦЕПТОРА ГУАНИЛАТЦИКЛАЗЫ У ПАЦИЕНТА, СПОСОБ ЛЕЧЕНИЯ ВИСЦЕРАЛЬНОЙ БОЛИ, СПОСОБ ПОЛУЧЕНИЯ ПОЛИПЕПТИДА (ВАРИАНТЫ), ИЗОЛИРОВАННАЯ МОЛЕКУЛА НУКЛЕИНОВОЙ КИСЛОТЫ, БАКТЕРИАЛЬНЫЙ ВЕКТОР ЭКСПРЕССИИ И ИЗОЛИРОВАННАЯ БАКТЕРИАЛЬНАЯ КЛЕТКА (POLYPEPTIDE FOR INCREASING GUANYLATE CYCLASE RECEPTOR ACTIVITY, PHARMACEUTICAL COMPOSITION, METHOD OF TREATING GASTROINTESTINAL DISORDER IN PATIENT, METHOD OF INCREASING GUANYLATE CYCLASE RECEPTOR ACTIVITY IN PATIENT, METHOD OF TREATING VISCERAL PAIN, METHOD OF OBTAINING POLYPEPTIDE (VERSIONS), ISOLATED NUCLEIC ACID MOLECULE, BACTERIAL EXPRESSION VECTOR AND ISOLATED BACTERIAL CELL) | ⤷ Try for Free |
Luxembourg | 92201 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for linaclotide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1594517 | C20130011 00400 | Estonia | ⤷ Try for Free | PRODUCT NAME: LINAKLOTIID;REG NO/DATE: K(2012)8832 (LOPLIK) 28.11.2012 |
1594517 | 122013000044 | Germany | ⤷ Try for Free | PRODUCT NAME: LINACLOTID, EINSCHLIESSLICH DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 |
1594517 | CR 2013 00026 | Denmark | ⤷ Try for Free | PRODUCT NAME: LINACLOTID OG FARMACEUTISKE ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/12/801/001-004 20121128 |
1594517 | 466 | Finland | ⤷ Try for Free | |
1594517 | CA 2013 00026 | Denmark | ⤷ Try for Free | |
1594517 | 92200 | Luxembourg | ⤷ Try for Free | 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 | 2013C/032 | Belgium | ⤷ Try for Free | PRODUCT NAME: LINACLOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Linaclotide
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