Viewing data from:

FINGOLIMOD HYDROCHLORIDE

ANDA

FINGOLIMOD HYDROCHLORIDE | A207993 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: GILENYA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. et al 1:2020cv00133 2 patentsANDA 207993, 210252, 207927, 207945, 207985, 207939, 207933, 208003, 207971, 207994Fingolimod	D. Del.	2020-01-28	Active	—
Novartis AG et al v. Apotex Inc. et al 0:2015cv62273 1 patentANDA 207993fingolimod	S.D. Fla.	2015-10-28	Terminated 2015-11-23	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$3.29

per ea

Lowest NADAC/Unit

$3.29

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505433203FINGOLIMOD 0.5 MG CAPSULE	$3.29	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain19 active DMFs2 inactive

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

ALIVUS LIFE SCIENCES LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 268072013

MATRIX PHARMACORP PRIVATE LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 277302013

MSN LABORATORIES PRIVATE LTDFINGOLIMOD HYDROCHLORIDE USP [ROUTE CODE "FH"]

DMF 278302013

APOTEX PHARMACHEM INDIA PVT LTDFINGOLIMOD HYDROCHLORIDE

DMF 279832014

ALEMBIC PHARMACEUTICALS LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 280572014

TAI HENG INDUSTRY GROUP CO LTDFINGOLIMOD HYDROCHLORIDE

DMF 281422014

TAPI NL BVFINGOLIMOD HYDROCHLORIDE

DMF 281482014

SHILPA PHARMA LIFESCIENCES LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 281622014

RUYUAN HEC PHARM CO LTDFINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 281652014

HONOUR LAB LTDFINGOLIMOD HYDROCHLORIDE

DMF 282252014

EMCURE PHARMACEUTICALS LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 282352014

BIOCON LTDFINGOLIMOD HYDROCHLORIDE

DMF 282762014

ZYDUS LIFESCIENCES LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 282782014

MAPRIMED SAFINGOLIMOD HYDROCHLORIDE (CODE 50996)

DMF 283222014

SUN PHARMACEUTICAL INDUSTRIES LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 283032014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDFINGOLIMOD HYDROCHLORIDE USP

DMF 283722014

INTAS PHARMACEUTICALS LTDFINGOLIMOD HYDROCHLORIDE (FORM 1)

DMF 283872014

MSN LABORATORIES PRIVATE LTDFINGOLIMOD HYDROCHLORIDE USP (FORM-I)

DMF 325422018

NOVUGEN PHARMA MALAYSIA SDN BHDFINGOLIMOD HYDROCHLORIDE USP

DMF 333282018

DR REDDYS LABORATORIES LTDInactiveFINGOLIMOD HYDROCHLORIDE

DMF 264012012

MSN LABORATORIES PRIVATE LTDInactiveFINGOLIMOD

DMF 323902017

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

Products (1)

#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 18, 2020

No patent or exclusivity listings for this strength.