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Generated: May 23, 2018

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Niacin - Generic Drug Details

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What are the generic drug sources for niacin and what is the scope of niacin freedom to operate?

Niacin
is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Sun Pharma Global, Abbvie, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Niacin has five patent family members in five countries.

There are fourteen drug master file entries for niacin. Twenty-two suppliers are listed for this compound.
Pharmacology for niacin
Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid
Medical Subject Heading (MeSH) Categories for niacin
Synonyms for niacin
.beta.-Pyridinecarboxylic acid
[3H]-Nicotinic acid
[3H]nicotinic acid
[5, 6-3H]-niacin
10361-13-4 (iron(2+) salt)
11054-EP2269610A2
11054-EP2269990A1
11054-EP2270002A1
11054-EP2270014A1
11054-EP2272825A2
11054-EP2272834A1
11054-EP2272848A1
11054-EP2274983A1
11054-EP2275401A1
11054-EP2277848A1
11054-EP2280001A1
11054-EP2289510A1
11054-EP2292228A1
11054-EP2292610A1
11054-EP2295406A1
11054-EP2295409A1
11054-EP2295424A1
11054-EP2298742A1
11054-EP2298772A1
11054-EP2298776A1
11054-EP2298779A1
11054-EP2301923A1
11054-EP2301929A1
11054-EP2301935A1
11054-EP2301937A1
11054-EP2305651A1
11054-EP2305674A1
11054-EP2308838A1
11054-EP2308839A1
11054-EP2308848A1
11054-EP2308854A1
11054-EP2308858A1
11054-EP2308874A1
11054-EP2311808A1
11054-EP2311816A1
11054-EP2311817A1
11054-EP2311829A1
11054-EP2311830A1
11054-EP2314588A1
11054-EP2316457A1
11054-EP2316458A1
11054-EP2316825A1
11054-EP2316826A1
11054-EP2316827A1
11054-EP2316828A1
123574-58-3
16518-17-5 (potassium salt)
1976-28-9 (aluminum salt)
2679MF687A
28029-53-0 (cobalt(2+) salt)
28029-54-1 (manganese(2+) salt)
3-Carboxylpyridine
3-Carboxypyridine
3-Picolinic acid
3-Picolinic acid; Niacin; Pellagra preventive factor; Pyridine-3-carboxylic acid; Vitamin B3
3-pyridine carboxylic acid
3-pyridinecarboxylic acid
3-Pyridinecarboxylicacid
3-Pyridyl carboxylic acid
3-Pyridylcarboxylic acid
36321-41-2 (ammonium salt)
3789-96-6 (tartrate)
3DDB011E-F3A6-45B6-A2D2-77B2A6E8936E
3PyrCOOH
5-22-02-00057 (Beilstein Handbook Reference)
5-pyridinecarboxylic acid
53890-72-5 (lithium salt)
54-86-4 (hydrochloride salt)
59-67-6
636-79-3 (hydrochloride)
7069-06-9 (magnesium salt)
823-77-8 (calcium salt)
99148-57-9 (tosylate)
AB00052050
AB00052050_14
AB00052050_15
AB00052050-13
AB1002056
ABT-919
AC-22484
AC-907/25014105
AC1L1AD5
AC1Q73P3
Acide nicotinique
Acide nicotinique [INN-French]
Acido nicotinico
Acido nicotinico [INN-Spanish]
Acidum nicotinicum
Acidum nicotinicum [INN-Latin]
ACMC-1AS6M
AI3-18994
AJ-08093
AK-46486
AKOS000118980
Akotin
AM81316
AN-23622
anti-Pellagra vitamin
antipellagra vitamin
ANW-75276
Apelagrin
Astra Brand of Niacinamide
BDBM23515
beta-pyridinecarboxylic acid
BIDD:GT0644
Bionic
bmse000104
BP-21419
BPBio1_000730
BRN 0109591
BSPBio_000662
BSPBio_002069
BT000120
C00253
C6H5NO2
CAS-59-67-6
Caswell No. 598
CCG-38340
CCRIS 1902
CHEBI:15940
CHEMBL573
CPD000059024
CS-1946
D00049
D06NVJ
Daskil
Davitamon PP
DB-007765
DB00627
Diacin
Direktan
DivK1c_000695
DSSTox_CID_932
DSSTox_GSID_20932
DSSTox_RID_75875
DTXSID1020932
EBD2198325
EC 200-441-0
Efacin
EINECS 200-441-0
Enduracin
EPA Pesticide Chemical Code 056701
F2191-0082
FC1287
FT-0082580
FT-0600004
GTPL1588
GTPL1594
HE019840
HE300411
HE302887
HMS1570B04
HMS1920P17
HMS2091H22
HMS2097B04
HMS2236A05
HMS3259K21
HMS3371E07
HMS3655K08
HMS502C17
HSDB 3134
HY-B0143
I02-0699
I14-92791
IDI1_000695
InChI=1/C6H5NO2/c8-6(9)5-2-1-3-7-4-5/h1-4H,(H,8,9
Induracin
J-523605
Jenapharm Brand of Niacinamide
KB-259513
KB-33243
KBio1_000695
KBio2_001543
KBio2_004111
KBio2_006679
KBio3_001569
KBioGR_001309
KBioSS_001543
KSC236Q9T
Kyselina nikotinova
Kyselina nikotinova [Czech]
L001199
Linic
LS-2334
M-5918
m-Pyridinecarboxylic acid
MCULE-3788394698
Merck Brand of Niacinamide
MFCD00006391
MLS000069603
MolPort-000-142-273
N0082
N1103
NAH
Naotin
NC00524
NCGC00016268-01
NCGC00016268-02
NCGC00016268-03
NCGC00016268-04
NCGC00016268-05
NCGC00016268-08
NCGC00016268-09
NCGC00094734-01
NCGC00094734-02
NCGC00256537-01
NCGC00258971-01
NCI60_001041
Ncotnc acd
Niac
Niacin (nicotinic acid)
Niacin (Nicotinic Acid), pharmaceutical secondary standard; traceability to USP and BP
Niacin (TN)
Niacin (USP)
Niacin [USAN]
Niacin [USP]
niacin magnesium
niacin potassium
Niacin-Vitamin B3
Niacin, United States Pharmacopeia (USP) Reference Standard
Niacinamide (TN)
Niacinamide Astra Brand
Niacinamide Jenapharm Brand
Niacinamide Merck Brand
Niacinamide Pharmagenix Brand
Niacinamide, Nicotinic acid amide, Nicotinamide
niacine
Niacor
Niacor (TN)
Niaspan
Niaspan (TN)
NIASPAN TITRATION STARTER PACK
Nicacid
Nicagin
nicamin
Nicangin
NICO
Nico-400
Nico-Span
nicobid
nicocap
Nicocidin
Nicocrisina
Nicodan
Nicodelmine
Nicodon
nicolar
Niconacid
Niconat
Niconazid
Nicorol
Nicosan 3
Nicoside
Nicosyl
Nicotamin
Nicotene
Nicotil
Nicotinamide (JP15/INN)
Nicotinamide (Niacinamide)
Nicotinamide (TN)
Nicotinamide-carbonyl-14C
nicotinate
Nicotine acid
nicotinic acid
Nicotinic acid (JP17/INN)
Nicotinic acid (Vitamin B3) solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Nicotinic acid [INN:BAN]
Nicotinic acid [INN]
Nicotinic Acid [Matrix for MALDI-TOF/MS]
Nicotinic Acid 1.0 mg/ml in Methanol
Nicotinic acid-d3(major)
Nicotinic acid, >=98%
Nicotinic acid, >=99.5% (HPLC)
Nicotinic acid, 99% 250g
Nicotinic acid, analytical standard
Nicotinic acid, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, >=98%
Nicotinic acid, certified reference material, TraceCERT(R)
Nicotinic acid, European Pharmacopoeia (EP) Reference Standard
Nicotinic acid, for inorganic trace analysis, >=99.999% (metals basis)
Nicotinic acid, for synthesis, 99%
Nicotinic acid, matrix substance for MALDI-MS, >=99.5% (HPLC)
Nicotinic acid, meets USP testing specifications
Nicotinic acid, NIST(R) SRM(R) 148
Nicotinic acid, Ph Eur
Nicotinic acid, plant cell culture tested
Nicotinic acid, purum, >=99.0% (HPLC)
Nicotinic acid, SAJ special grade, >=99.5%
Nicotinic acid, Vetec(TM) reagent grade, >=98%
Nicotinicacid
Nicotinipca
Nicotinsaure
Nicotinsaure [German]
Nicovasan
Nicovasen
Nicyl
Nikasan
Nikazan
Nikotinsaeure
NINDS_000695
NIO
Nipellen
NSC 169454
NSC-169454
NSC-757241
NSC169454
NSC757241
Nyclin
Opera_ID_1346
Oprea1_514398
P.P. factor
P.P. factor-pellagra preventive factor
pellagra
Pellagra preventive factor
Pellagramin
Pellagrin
Pelonin
Peviton
Pharmagenix Brand of Niacinamide
Pharmakon1600-01500430
PP Factor
Prestwick0_000881
Prestwick1_000881
Prestwick2_000881
Prestwick3_000881
preventative factor
PS-4255
PubChem2594
PVNIIMVLHYAWGP-UHFFFAOYSA-N
Pyridine-.beta.-carboxylic acid
Pyridine-3-carbonic acid
Pyridine-3-carboxylic acid
Pyridine-beta-carboxylic acid
Pyridine-carboxylique-3
Pyridine-carboxylique-3 [French]
Pyridinecarboxylic acid, 3-
Pyridylcarboxylic Acid
RP00705
S115
s1744
SAM002554917
SBB004279
SBI-0051456.P003
SC-05611
SCHEMBL1433
SDCCGMLS-0066610.P001
SK-Niacin
Slo-niacin
SMR000059024
SPBio_000011
SPBio_002881
Spectrum_001063
SPECTRUM1500430
Spectrum2_000006
Spectrum3_000515
Spectrum4_000965
Spectrum5_001287
SR 4390
SR-01000722017
SR-01000722017-2
ST097540
ST2413625
STK301803
STR00112
Tega-Span
Tinic
Tox21_110337
Tox21_110337_1
Tox21_201420
Tox21_302904
TR-032523
UNII-2679MF687A
vitamin B3
Vitamin B3 (Niacin)
Vitaplex N
wampocap
WLN: T6NJ CVQ
Z56755709
ZINC1795

US Patents and Regulatory Information for niacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt NIACIN niacin TABLET;ORAL 081134-001 Apr 28, 1992 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz NIACIN niacin TABLET;ORAL 083306-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs NIACIN niacin TABLET;ORAL 083305-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Jubilant Generics NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209156-003 May 14, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Baxter
Cerilliant
Cantor Fitzgerald
Julphar
Johnson and Johnson
QuintilesIMS
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.