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NIACIN

ANDA

NIACIN | A204178 | AMNEAL PHARMACEUTICALS

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Amneal Pharmaceuticals LLC. et al 1:2012cv01088 1 patentANDA 204178niacin (nicotinic acid)	D. Del.	2012-08-30	Terminated 2013-02-14	—

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

API Supply Chain4 active DMFs4 inactive

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

AURORIUM LLCNIACIN USP

DMF 82591989

DIVIS LABORATORIES LTDNIACIN USP

DMF 184812005

AARTI DRUGS LTDNIACIN

DMF 200512006

JUBILANT PHARMOVA LTDNIACIN USP

DMF 313822017

WOCKHARDT LTDInactiveNIACIN

DMF 76421988

LONZA AGInactiveNIACIN USP SPECIAL

DMF 80411989

LONZA LTDInactiveNIACIN USP GRANULAR SPECIAL

DMF 182932005

ABBVIE INCInactiveNIACIN CORE TABLET INTERMEDIATE

DMF 218762008

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

Products (1)

#001 — 750MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 11, 2015

No patent or exclusivity listings for this strength.