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ELUXADOLINE

ANDA

ELUXADOLINE | A213522 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan USA, Inc., et al. v. MSN Laboratories Private Limited, et al. 1:2019cv01727 6 patentsANDA 213511, 213613, 213427, 213576, 213447, 213522eluxadoline	D. Del.	2019-09-13	Terminated 2025-01-02	—

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

API Supply Chain6 active DMFs

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

MSN LIFE SCIENCES PRIVATE LTDELUXADOLINE

DMF 321482017

ALKEM LABORATORIES LTDELUXADOLINE

DMF 333722019

HONOUR LAB LTDELUXADOLINE

DMF 333842018

SUN PHARMACEUTICAL INDUSTRIES LTDELUXADOLINE

DMF 335682019

APITORIA PHARMA PRIVATE LTDELUXADOLINE

DMF 335902019

LEE PHARMA LTDELUXADOLINE

DMF 424682025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 14, 2025

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 14, 2025