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LINACLOTIDE

ANDA

LINACLOTIDE | A209564 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Forest Laboratories, LLC et al v. Mylan Pharmaceuticals Inc. 1:2017cv01728 10 patentsANDA 209564linaclotide	D. Del.	2017-11-30	Terminated 2018-08-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain14 active DMFs2 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

CORDEN PHARMA COLORADO INCLINACLOTIDE

DMF 249922011

POLYPEPTIDE LABORATORIES SWEDEN ABLINACLOTIDE DRUG SUBSTANCE

DMF 250212011

POLYPEPTIDE LABORATORIES INCLINACLOTIDE DRUG SUBSTANCE

DMF 250252011

AURO PEPTIDES LTDLINACLOTIDE

DMF 297082015

SUN PHARMACEUTICAL INDUSTRIES LTDLINACLOTIDE

DMF 302662016

TAPI NL BVLINACLOTIDE

DMF 302742016

MSN LIFE SCIENCES PRIVATE LTDLINACLOTIDE

DMF 313512017

HYBIO PHARMACEUTICAL CO LTDLINACLOTIDE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 323142017

CHENGDU SHENGNUO BIOPHARM CO LTDLINACLOTIDE

DMF 358122021

HYBIO PHARMACEUTICAL CO LTDLINACLOTIDE NON-STERILE DRUG SUBSTANCE

DMF 373702022

HANGZHOU THINHEAL PHARMA-TECH CO LTDLINACLOTIDE

DMF 399012024

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDLINACLOTIDE

DMF 420402025

ZHEJIANG PEPTITES BIOTECH CO LTDLINACLOTIDE

DMF 420492025

SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTDLINACLOTIDE

DMF 426352025

BACHEM AMERICAS INCInactiveLINACLOTIDE (BULK)

DMF 282732014

MSN LIFE SCIENCES PRIVATE LTDInactiveLINACLOTIDE [ROUTE CODE LE]

DMF 304212016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 10, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 145MCG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 9, 2021

No patent or exclusivity listings for this strength.

#002 — 290MCG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 9, 2021