NIACIN Drug Patent Profile
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Which patents cover Niacin, and what generic alternatives are available?
Niacin is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Eywa, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt. and is included in thirty NDAs.
The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Niacin
A generic version of NIACIN was approved as niacin by BARR on April 14th, 2005.
Summary for NIACIN
Recent Clinical Trials for NIACIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rhode Island Hospital | Early Phase 1 |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
University of Alabama at Birmingham | Phase 2 |
Pharmacology for NIACIN
Drug Class | Nicotinic Acid |
Medical Subject Heading (MeSH) Categories for NIACIN
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | NIACIN | niacin | TABLET;ORAL | 083306-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Yichang Humanwell | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 212017-001 | Jun 10, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | NIACIN | niacin | TABLET;ORAL | 085172-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 200484-002 | Apr 23, 2014 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Yichang Humanwell | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 212017-002 | Jun 10, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 200484-001 | Apr 23, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amneal Pharms | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 203578-002 | Jul 24, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |