Viewing data from:

BETADINE

NDA

POVIDONE-IODINE | N018634 | ALCON PHARMACEUTICALS LTD

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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis:NCT07675915	N/A	Not Yet Recruiting	Tanta University	40	2026-06-30 → 2027-07-30
Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections NCT07232446	—	Completed	Alaattin Karabulut	98	2025-11-25 → 2026-04-15

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

Medicare Part D Spending

CMS annual spending data for Betadine (2023)

Total Spending

$1K

Total Claims

Beneficiaries

Avg Cost/Unit

$0.57

Spending Trend

$1K(2019)→$967.64(2020)→$1K(2021)→$2K(2022)→$1K(2023)

YoY Change:+13.0%

5yr CAGR:-5.0%

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

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

BASF SEPOVIDONE-IODINE

DMF 30171977

SHANGHAI YUKING WATER SOLUBLE MATERIAL TECH CO LTDPOVIDONE-IODINE

DMF 298882015

HUZHOU SUNFLOWER PHARMACEUTICAL CO LTDPOVIDONE-IODINE

DMF 334622018

PRACHI PHARMACEUTICALS PVT LTDPOVIDONE-IODINE USP

DMF 336192019

RN LABORATORIES EUROPE BVPOVIDONE-IODINE USP (1-VINYL-2-PYRROLIDINONE POLYMER, COMPOUND WITH IODINE)

DMF 344872020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2003	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 17, 1986

No patent or exclusivity listings for this strength.