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 Mylan and Allergan, and is included in two 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 eight patent family members in forty-two 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: | 208 |
US Patents: | 12 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 41 |
Patent Applications: | 1,337 |
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 |
---|---|
Zhiguo Liu | N/A |
National Cancer Institute (NCI) | Early Phase 1 |
Affiliated Hospital of Zunyi Medical University | N/A |
Generic filers with tentative approvals for LINACLOTIDE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
---|---|---|---|
Hong Kong | 1161978 | 適合口服給藥的鳥苷酸環化酶- 受體激動劑多肽的穩定的固體製劑 (STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION -C) | See Plans and Pricing |
Turkey | 201711271 | See Plans and Pricing | |
Philippines | 12015501579 | STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION | See Plans and Pricing |
Russian Federation | 2014153593 | СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЖЕЛУДОЧНО-КИШЕЧНЫХ РАССТРОЙСТВ | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for linaclotide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2246360 | 300594 | Netherlands | See Plans and Pricing | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 |
1594517 | PA2013013,C1594517 | Lithuania | See Plans and Pricing | PRODUCT NAME: LINAKLOTIDAS; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126 |
1594517 | 1390024-6 | Sweden | See Plans and Pricing | PRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126 |
1594517 | C300593 | Netherlands | See Plans and Pricing | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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