Tavaborole – USA

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.

Leave a Reply

Leave a Reply

Your email address will not be published.

Disclaimer
All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2022 Pharma IP Circle. All Rights Reserved