Niacin Patent Expiration

Niacin is Used for treating hyperlipidemia by dosing once daily in the evening or at night to reduce elevated total cholesterol, LDL cholesterol, and triglyceride levels, and increase HDL cholesterol levels. It was first introduced by Medpointe Pharmaceuticals Medpointe Healthcare Inc in its drug Wampocap on Approved Prior to Jan 1, 1982. Other drugs containing Niacin are Niaspan Titration Starter Pack, Niaspan. 29 different companies have introduced drugs containing Niacin.


Niacin Patents

Given below is the list of patents protecting Niacin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Niaspan US6469035 Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acid Mar 15, 2018

(Expired)

Abbvie
Niaspan US6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor May 27, 2017

(Expired)

Abbvie
Niaspan Titration Starter Pack US6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor May 27, 2017

(Expired)

Abbvie
Niaspan US6818229 Intermediate release nicotinic acid compositions for treating hyperlipidemia Feb 15, 2014

(Expired)

Abbvie
Niaspan US6129930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night Sep 20, 2013

(Expired)

Abbvie
Niaspan US6406715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles Sep 20, 2013

(Expired)

Abbvie
Niaspan US6676967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia Sep 20, 2013

(Expired)

Abbvie
Niaspan US6746691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics Sep 20, 2013

(Expired)

Abbvie
Niaspan US6818229 Intermediate release nicotinic acid compositions for treating hyperlipidemia Sep 20, 2013

(Expired)

Abbvie
Niaspan US7011848 Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor Sep 20, 2013

(Expired)

Abbvie
Niaspan US7998506 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor Sep 20, 2013

(Expired)

Abbvie
Niaspan Titration Starter Pack US6129930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night Sep 20, 2013

(Expired)

Abbvie
Niaspan Titration Starter Pack US6406715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles Sep 20, 2013

(Expired)

Abbvie
Niaspan Titration Starter Pack US6746691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics Sep 20, 2013

(Expired)

Abbvie
Niaspan Titration Starter Pack US7011848 Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor Sep 20, 2013

(Expired)

Abbvie



Niacin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Niacin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants University of California, Davis NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Study of Niacin in Glioblastoma AHS Cancer Control Alberta NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery Henry Ford Health System NA TERMINATED
(Aug 1, 2026)
PHASE2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain Yale University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Sirtuin-NAD Activator in Alzheimer's Disease Brigham and Women's Hospital NA COMPLETED
(Jun 1, 2026)
PHASE1, PHASE2
Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer Sunstone Medical NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Study of Psilocybin for Major Depressive Disorder (MDD) Usona Institute NA COMPLETED
(Mar 1, 2026)
PHASE2


Niacin Generic API Manufacturers

Several generic applications have been filed for Niacin. The first generic version for Niacin was by Everylife and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Mpp Pharma Llc and was approved on Jul 25, 2025.

Given below is the list of companies who have filed for Niacin generic, along with the locations of their manufacturing plants worldwide.