Viewing data from:

VEREGEN

NDA

SINECATECHINS | N021902 | ANI PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

Today

7858662

Oct. 2, 2026

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

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males NCT04055142	Phase 3	Completed	Hospital Universitari Vall d'Hebron Research Institute	108	2020-09-18 → 2024-07-02
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment NCT02147353	N/A	Completed	Icahn School of Medicine at Mount Sinai	42	2011-09 → 2012-12
Topical Green Tea Ointment in Treatment of Superficial Skin Cancer NCT02029352	Phase 2/3	Completed	Maastricht University Medical Center	42	2014-11 → 2016-02
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment NCT03682601	Phase 2	Terminated	GTO Pharmaceutical, LLC	32	2018-08-30 → 2021-02-13

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$51.51

per gm

Lowest NADAC/Unit

$51.51

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559038530VEREGEN 15% OINTMENT	$51.51	GM	Brand	—	2025-11-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$918.67

Highest Price

$918.67

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0385-30VEREGEN 15% OINT,TOP	$918.67	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0385-30VEREGEN 15% OINT,TOP	$918.67	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Veregen (2024)

Total Spending

$223K

Total Claims

126

Beneficiaries

Avg Cost/Unit

$51.68

Spending Trend

$335K(2019)→$223K(2020)→$273K(2021)→$239K(2022)→$235K(2023)→$223K(2024)

YoY Change:-8.3%

5yr CAGR:-8.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -33	View Letter (PDF)
Mar 4, 2013	SUPPL -26	View Letter (PDF)
Nov 21, 2012	SUPPL -25	View Letter (PDF)
Sep 23, 2008	SUPPL -17	View Letter (PDF)
Jan 9, 2008	SUPPL -2	View Letter (PDF)
Jun 7, 2007	SUPPL -1	View Letter (PDF)
Nov 6, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15%

RLD

1 patent0 exclusivities▴

OINTMENT;TOPICAL | Approved: Oct 31, 2006

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7858662	Oct 2, 2026	—	—	Yes		—