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KERYDIN

NDA

TAVABOROLE | N204427 | ANACOR PHARMACEUTICALS 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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Anacor Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al 1:2019cv00632	D. Del.	2019-04-04	Terminated 2019-10-28	—
In re: Kerydin (Tavaborole) Topical Solution 5% Patent Litigation 1:2019md02884 tavaborole	D. Del.	2019-04-03	Terminated 2020-09-11	—
Anacor Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al 1:2018cv01699 4 patentsANDA 212065tavaborole	D. Del.	2018-10-29	Terminated 2019-03-04	—
Anacor Pharmaceuticals, Inc. v. Ascent Pharmaceuticals, Inc. et al 1:2018cv01673	D. Del.	2018-10-25	Terminated 2020-09-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents NCT03405818	Phase 4	Completed	Pfizer	55	2015-10-22 → 2017-07-27

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

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Tavaborole (2024)

Total Spending

$20.4M

Total Claims

34,010

Beneficiaries

11,464

Avg Cost/Unit

$50.71

YoY Change:+16.5%

5yr CAGR:-17.9%

Kerydin (2023)

Total Spending

$19K

Total Claims

Beneficiaries

Avg Cost/Unit

$138.44

Spending Trend

$8.4M(2019)→$6.4M(2020)→$723K(2021)→$152K(2022)→$19K(2023)

YoY Change:+2.8%

5yr CAGR:-1.8%

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

API Supply Chain6 active DMFs

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

ALIVUS LIFE SCIENCES LTDTAVABOROLE

DMF 312832017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTAVABOROLE

DMF 314312017

TARO PHARMACEUTICAL INDUSTRIES LTDTAVABOROLE

DMF 320832018

MSN LIFE SCIENCES PRIVATE LTDTAVABOROLE

DMF 321542017

WAVELENGTH ENTERPRISES LTDTAVABOROLE

DMF 323152017

HONOUR LAB LTDTAVABOROLE

DMF 325332018

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 3, 2018	SUPPL -6	View Letter (PDF)
Mar 2, 2015	SUPPL -3	View Letter (PDF)
Jul 9, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Jul 7, 2014

No patent or exclusivity listings for this strength.