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WAMPOCAP

NDA

NIACIN | N011073 | MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov — 9 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Food Supplement for Longevity NCT07659834	N/A	Active	Sam Treadway	18	2026-03-06 → 2026-08-01
NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome NCT07278492	Phase 1	Not Yet Recruiting	Brigham and Women's Hospital	24	2026-07-31 → 2028-06-30
Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery NCT07013591	Phase 2	Recruiting	Brigham and Women's Hospital	90	2026-06-10 → 2029-01-01
Adiposity and Iron Requirements in Pregnancy NCT06425796	N/A	Recruiting	University of Ulster	312	2024-05-20 → 2027-03-19
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.NCT06843148	N/A	Recruiting	Université de Sherbrooke	36	2026-06-22 → 2030-07
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder NCT05452772	Phase 2	Recruiting	Johns Hopkins University	66	2023-11-01 → 2027-05
Assessing the Safety and Tolerability of NMN in DHDDS-CDG NCT07572825	Phase 1	Recruiting	Eva Morava-Kozicz	8	2026-05-08 → 2027-08-01
Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus NCT06032923	Phase 1/2	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	78	2024-03-13 → 2028-08-01
Clinical Trial on the Protective Role of Vitamin B3 in Enhancing Immunotherapy for Bladder Cancer Patients NCT07119996	Phase 1	Recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	12	2025-08-01 → 2027-02-01
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy NCT06200155	Phase 2	Recruiting	M.D. Anderson Cancer Center	30	2024-04-16 → 2026-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Niacin ER (2023)

Total Spending

$18.3M

Total Claims

173,079

Beneficiaries

42,698

Avg Cost/Unit

$1.21

Spending Trend

$43.8M(2019)→$34.1M(2020)→$25.6M(2021)→$24.2M(2022)→$18.3M(2023)

YoY Change:-16.4%

5yr CAGR:-11.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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 PHARMOVA 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 (1)

#003 — 500MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.