Tavaborole - USA

IPR decision: Jun 05, 2019

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Final Written Decision
IPR2018-00168	11/21/2017	06/08/2018	FlatWing & Mylan	9,549,938	Anacor Pharma	Claims 1–6 are unpatentable
IPR2018-00169	11/21/2017	06/08/2018	FlatWing & Mylan	9,566,289	Anacor Pharma	Claims 1–15 are unpatentable
IPR2018-00170	11/21/2017	06/14/2018	FlatWing & Mylan	9,566,290	Anacor Pharma	Claims 1–12 are unpatentable
IPR2018-00171	11/21/2017	06/14/2018	FlatWing & Mylan	9,572,823	Anacor Pharma	Claims 1–6 are unpatentable

Note: Mylan’s IPRs joined with Faltwing’s IPR petitions

US 9,549,938 (Anacor Pharmaceuticals, Inc.; Exp: 08/16/2026 with PED) – OB listed

1. A method of treating a Tinea unguium infection of a toenail of a human, the method comprising: topically administering to the toenail of the human a pharmaceutical composition comprising 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof in an amount sufficient to treat the infection.

US 9,566,289 (Anacor Pharmaceuticals, Inc.; Exp: 08/16/2026 with PED) – OB listed

1. A pharmaceutical formulation, comprising: 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable topical carrier.

12. A pharmaceutical formulation, comprising: about 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof; propylene glycol; ethanol; and ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof.

US 9,566,290 (Anacor Pharmaceuticals, Inc.; Exp: 08/16/2026 with PED) – OB listed

1. A method of treating a human having onychomycosis of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising: topically administering to the toenail a pharmaceutical composition comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes.

US 9,572,823 (Anacor Pharmaceuticals, Inc.; Exp: 08/16/2026 with PED) – OB listed

1. A method of delivering a compound, in a human, from a dorsal layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising: contacting the dorsal layer of the nail plate with a pharmaceutical composition comprising a compound that penetrates the nail plate, the compound being 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.

Orange book lists 1 more patent for Tavaborole (KERYDIN) solution; US 7,582,621 (expiring on 11/26/2027). On US 7,582,621 patent, Coalition for Affordable Drugs filed IPR (IPR2015-01776) on Aug 20, 2015. PTAB issued final written decision on Feb 23, 2017 & held claims 1–12 unpatentable. Anacor Pharmaceuticals appealed this IPR decision (cafc 17-1947) & Federal Circuit affirmed PTAB decision on May 05, 2018.

With respect to Hatch-Waxman litigation, many ANDA filers (Lupin, Encube, Glasshouse, Flatwing, Aleor, Amneal, Apotex, Ascent, Aurobindo, Cipla, Perrigo, Taro, Zydus  & Mylan) filed ANDA for tavaborole on NCE-1 date of Jul 07, 2018. These cases are under discovery phase in Delaware court. Bench trial is scheduled on Apr 12, 2021.