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TAVABOROLE

ANDA

TAVABOROLE | A211297 | ENCUBE ETHICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Anacor Pharmaceuticals, Inc. v. Lupin Limited et al 1:2018cv01606 4 patentsANDA 212168, 211297, 212116, 2119631,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole (tavaborole)	D. Del.	2018-10-17	Terminated 2020-09-11	—

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

Medicare Part D Spending

CMS annual spending data for Tavaborole (2023)

Total Spending

$17.1M

Total Claims

27,414

Beneficiaries

9,367

Avg Cost/Unit

$43.59

Spending Trend

$808K(2020)→$7.6M(2021)→$15.1M(2022)→$17.1M(2023)

YoY Change:-14.6%

5yr CAGR:-26.9%

Source: CMS Medicare Part D Spending by Drug (2023). 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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Oct 13, 2020

No patent or exclusivity listings for this strength.