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Prescription medicine

Sinecatechins Brand names: Veregen

Sinecatechins (Veregen) is a prescription medicine with an FDA approval on record since 2006. No generic is listed; pharmacies paid $50.96 per gram (Veregen 15% ointment) in the October 7, 2026 NADAC survey.

  • No generic listed

Check it at the source: the sinecatechins FDA label on DailyMed (effective November 10, 2022, ANI Pharmaceuticals, Inc.); the NDA 21902 record on Drugs@FDA; every sinecatechins label on DailyMed.

Highlights of the record

FDA label of November 10, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1).

Forms and strengths

  • 150 mg/g

Ointment.

On the market

Earliest approval on file
October 31, 2006 Veregen, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
October 2, 2026 Veregen ointment; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$50.96 per gram Veregen 15% ointment
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
54 through July 30, 2026

What is sinecatechins used for?

From the label: indications and usage

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1). […]

Source: FDA drug label (Veregen), NDA021902 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective November 10, 2022 (SPL set f0fc1e21-e3cf-4bce-860c-307f670b192e), via openFDA; the full label on DailyMed

What does the patient leaflet for sinecatechins say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using Veregen Ointment?

Do not apply Veregen Ointment on open wounds or into the vagina or into the anus. • Genital warts are a sexually transmitted disease, and you may infect your partner. • Avoid sexual contact (genital, anal or oral) when Veregen Ointment is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms. Talk to your doctor about safe sex practices. • Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s). • Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina. • Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily. […]

From the patient leaflet: How should I store Veregen Ointment?

Store Veregen Ointment refrigerated or up to 77°F (25°C). • Do not freeze. • Make sure the cap on the tube is tightly closed. • Safely throw away Veregen Ointment tubes that are out of date or are empty. Keep Veregen Ointment and all medicines out of the reach of children. General advice about prescription medicines Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen Ointment for a condition for which it was not prescribed. Do not give Veregen Ointment to other people, even if they have the same symptoms you have. It may harm them. Do not use Veregen Ointment after the expiration date on the tube. This leaflet summarizes the most important information about Veregen Ointment. If you would like more information, talk with your doctor. […]

Source: FDA drug label (Veregen), NDA021902 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective November 10, 2022 (SPL set f0fc1e21-e3cf-4bce-860c-307f670b192e), via openFDA; the full label on DailyMed

Is there a generic for sinecatechins (Veregen)?

No generic sinecatechins is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Veregen ointment, the last expiring on October 2, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2006 earliest approval on file
  • 2026 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for sinecatechins (Veregen)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $50.96 per gram (Veregen 15% ointment), down 1% from $51.51 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Veregen 15% ointment (brand)
$51.51
$50.91
June 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Veregen 15% ointmentBrand$50.96 per gramn/a-1%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What do FAERS reports show for sinecatechins?

The FDA Adverse Event Reporting System holds 54 reports that list sinecatechins among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 13 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Cellulitis6
  • Application Site Pain5
  • Drug Ineffective (a use or a product term, not a reaction)5
  • Pain4
  • Product Use Issue (a use or a product term, not a reaction)4
  • Application Site Erythema3
  • Erythema (named in the label)3
  • Off Label Use (a use or a product term, not a reaction)3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Sinecatechins side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other