FDA Orange Book · active-ingredient family
Niacin
Niacin is approved as 2 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NIASPAN · NDA 020381
2
Brand (NDA)
34
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIASPANRLD×5 | ABBVIE | NDA 020381 | — | Jul 28, 1997 | |
| WAMPOCAP | MEDPOINTE PHARM HLC | NDA 011073 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIACIN×3 | MPP PHARMA | ANDA 207726 | AB | Jul 25, 2025 | |
| NIACIN×3 | ZYDUS PHARMS | ANDA 203285 | — | Apr 28, 2025 | |
| NIACIN×3 | HIBROW HLTHCARE | ANDA 213090 | AB | Aug 25, 2023 | |
| NIACIN×2 | MACLEODS PHARMS LTD | ANDA 204934 | AB | Mar 03, 2022 | |
| NIACIN×2 | BEIJING | ANDA 214428 | — | Nov 22, 2021 | |
| NIACIN×3 | YICHANG HUMANWELL | ANDA 212017 | — | Jun 10, 2019 | |
| NIACIN×3 | RISING | ANDA 203742 | — | Feb 22, 2019 | |
| NIACIN×3 | JUBILANT GENERICS | ANDA 209156 | — | May 14, 2018 | |
| NIACIN×3 | AUROBINDO PHARMA LTD | ANDA 209236 | AB | Feb 01, 2018 | |
| NIACIN×2 | LANNETT CO INC | ANDA 203899 | AB | Jun 16, 2017 | |
| NIACIN | AMNEAL PHARMS | ANDA 204178 | AB | Dec 11, 2015 | |
| NIACIN×2 | AMNEAL PHARMS | ANDA 203578 | AB | Jul 24, 2015 | |
| NIACIN×2 | SUN PHARM | ANDA 200484 | AB | Apr 23, 2014 | |
| NIACIN | SUN PHARM | ANDA 201273 | AB | Apr 23, 2014 | |
| NIACIN | CHARTWELL RX | ANDA 090446 | AB | Mar 20, 2014 | |
| NIACIN | CHARTWELL RX | ANDA 090860 | AB | Mar 20, 2014 | |
| NIACIN | CHARTWELL RX | ANDA 090892 | AB | Mar 20, 2014 | |
| NIACIN×2 | BARR | ANDA 076378 | AB | Apr 26, 2005 | |
| NIACIN | BARR | ANDA 076250 | AB | Apr 14, 2005 | |
| NIACOR | AVONDALE PHARMS | ANDA 040378 | — | May 03, 2000 | |
| NIACIN | WOCKHARDT | ANDA 081134 | — | Apr 28, 1992 | |
| NIACIN | EVERYLIFE | ANDA 083203 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | HALSEY | ANDA 083453 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | HIKMA | ANDA 083718 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | IMPAX LABS | ANDA 083115 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | IVAX SUB TEVA PHARMS | ANDA 083180 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | MK LABS | ANDA 083525 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | PUREPAC PHARM | ANDA 083271 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | SANDOZ | ANDA 083306 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | TABLICAPS | ANDA 084237 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | WATSON LABS | ANDA 083136 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | WATSON LABS | ANDA 083305 | — | Approved Prior to Jan 1, 1982 | |
| NIACIN | WATSON LABS | ANDA 085172 | — | Approved Prior to Jan 1, 1982 | |
| NICOLARRLD | SANOFI AVENTIS US | ANDA 083823 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Niacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
