EFINACONAZOLE | N203567 | BAUSCH HEALTH AMERICAS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2017-00190 | 7214506 | IPR | Acrux DDS Pty Ltd. et al. | Final Written Decision | 2016-11-02 | — |
| IPR2017-01429 | 7214506 | IPR | Argentum Pharmaceuticals LLC et al. | Terminated-Settled | 2017-05-12 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bausch Health US, LLC et al v. Mylan Pharmaceuticals Inc. 12 patentsANDA 212064efinaconazole | WVND | 2020-03-13 | Terminated 2021-01-05 | — |
BAUSCH HEALTH US, LLC et al v. ALKEM LABORATORIES LTD. 3 patentsANDA 212195efinaconazole | D.N.J. | 2020-03-12 | Terminated 2020-04-21 | — |
BAUSCH HEALTH US, LLC et al v. ALEOR DERMACEUTICALS LTD. 3 patentsANDA 212027efinaconazole | D.N.J. | 2020-03-12 | Terminated 2020-05-14 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. MYLAN PHARMACEUTICALS INC. et al 9 patentsANDA 212064efinaconazole | D.N.J. | 2019-03-08 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. APOTEX INC. et al 9 patentsANDA 212101efinaconazole | D.N.J. | 2019-02-15 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 9 patentsANDA 212178efinaconazole | D.N.J. | 2019-02-08 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. TEVA PHARMACEUTICALS USA, INC. et al 9 patentsANDA 211827efinaconazole | D.N.J. | 2019-01-23 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. CIPLA LTD. et al 1 patentANDA 212111efinaconazole | D.N.J. | 2019-01-23 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. STRIDES PHARMA INC. et al 1 patentANDA 211985efinaconazole | D.N.J. | 2019-01-04 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. AMNEAL PHARMACEUTICALS LLC et al 8 patentsANDA 212085efinaconazole | D.N.J. | 2018-09-28 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. KVK-TECH, INC. 8 patentsANDA 212213efinaconazole | E.D. Pa. | 2018-09-27 | Terminated 2019-02-05 | — |
Bausch Health US, LLC et al v. Mylan Pharmaceuticals Inc. et al 8 patentsANDA 212064efinaconazole | WVND | 2018-09-27 | Terminated 2021-01-05 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. MYLAN PHARMACEUTICALS INC. et al 8 patentsANDA 212064efinaconazole | D.N.J. | 2018-09-26 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. KVK-TECH, INC. 8 patentsANDA 212213efinaconazole | D.N.J. | 2018-09-26 | Terminated 2019-04-15 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. PAR PHARMACEUTICAL, INC. 8 patentsANDA 211742efinaconazole | D.N.J. | 2018-09-09 | Terminated 2018-12-12 | — |
VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. SOLARIS PHARMA CORP. 8 patentsANDA 212159efinaconazole | D.N.J. | 2018-09-07 | Terminated 2019-04-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubliant Generics Limited FDA-2017-P-7033 Jubilant Generics Limited submitted this petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting the FDA determine that Oxcarbazepine Oral Tablet 450 mg (dual scored) is suitable for consideration in an ANDA, with TRILEPTAL Tablets (150, 300, and 600 mg) under NDA 0 | Other | 2017-12-29 | Open | Jubliant Generics Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7214506 | Feb 22, 2026 | — | — | — | — | |
| 8039494 | Jul 8, 2030 | — | — | — | — | |
| 8486978 | Oct 24, 2030 | — | — | Yes | — | — |
| 9302009 | Oct 24, 2030 | — | — | Yes | — | — |
| 9566272 | Jan 3, 2028 | — | — | — | — | |
| 9662394 | Oct 2, 2034 | — | — | Yes | — | — |
| 9861698 | Jul 8, 2030 | — | — | Yes | — | — |
| 9877955 | Jan 3, 2028 | — | — | — | — | |
| 10105444 | Jul 8, 2030 | — | — | Yes | — | — |
| 10342875 | Oct 2, 2034 | — | — | Yes | — | |
| 10478601 | Apr 25, 2035 | — | — | Yes | — | |
| 10512640 | Jan 3, 2028 | — | — | — | — | |
| 10828293 | Oct 2, 2034 | — | — | — | — | |
| 10828369 | Jan 3, 2028 | — | — | Yes | — | — |
| 10864274 | Oct 2, 2034 | — | — | — | — | |
| 11213519 | Jan 3, 2028 | — | — | — | — | |
| 11654139 | Oct 2, 2034 | — | — | — | — | |
| 11872218 | Jan 3, 2028 | — | — | — | — |