Viewing data from:

NIACIN

ANDA

NIACIN | A200484 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Abbott Laboratories et al v. Impax Laboratories Inc. 1:2010cv01029 8 patentsANDA 202149, 090446, 090860, 090892, 200478, 200601, 200484, 201273, 201403, 201521niacin extended-release / simvastatin	D. Del.	2010-11-24	Terminated 2012-09-11	—
Abbott Laboratories et al v. Sun Pharmaceutical Industries, Ltd. et al 2:2010cv10656 2 patentsANDA 200484niacin extended-release	E.D. Mich.	2010-02-16	Terminated 2010-04-19	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.2893

per ea

Lowest NADAC/Unit

$0.1492

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47335061381NIACIN ER 1,000 MG TABLET	$0.2893	EA	Generic	—	2026-06-17
47335053981NIACIN ER 500 MG TABLET	$0.1492	EA	Generic	—	2026-06-17

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

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 BIOSYS 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 (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 23, 2014

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 23, 2014