Linaclotide
Overview
Linaclotide is a guanylate cyclase-C agonist used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation. It works by increasing the secretion of chloride and bicarbonate into the intestinal lumen, resulting in increased intestinal fluid and accelerated transit.
API suppliers (12)
Suppliers of Linaclotide evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 10 of 12 suppliers.
3 of 12 hold a GMP certificate on record in the EU or UK registers
- CORDEN PHARMA COLORADO INC1 active DMF
- AURO PEPTIDES LTD1 active DMF
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- TAPI NL BVNetherlands1 active DMF
- MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
- CHENGDU SHENGNUO BIOPHARM CO LTDChina1 active DMF
- HANGZHOU THINHEAL PHARMA-TECH CO LTDChina1 active DMF
- HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDChina1 active DMF
- ZHEJIANG PEPTITES BIOTECH CO LTDChina1 active DMF
- SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTDChina1 active DMF
- Zhejiang Supor Pharmaceuticals Co., LtdChina1 active DMF GMP on record
- Wisdom Pharmaceutical Co., LtdChina1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (3 approved US products), the latest listed US patent on Linaclotide expires 16 Feb 2034 and exclusivity 21 May 2029. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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