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NIASPAN

NDA

NIACIN | N020381 | ABBVIE INC

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Watson Laboratories Inc. - Florida 1:2012cv01409 2 patentsANDA 203570niacin	D. Del.	2012-11-08	Terminated 2013-09-12	—
AbbVie Inc. et al v. Watson Laboratories Inc. - Florida 1:2012cv00324 2 patentsANDA 203570niacin (nicotinic acid)	D. Del.	2012-03-16	Terminated 2013-09-12	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

18 letters from Drugs@FDA

Source: Drugs@FDA application documents.