BENDAMUSTINE HYDROCHLORIDE | N022249 | CEPHALON INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-00503 | 8436190 | IPR | AGILA SPECIALTIES INC. | Terminated-Settled | 2014-12-24 | — |
| IPR2016-00098 | 8791270 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2015-10-28 | — |
| IPR2016-00026 | 8791270 | IPR | AGILA SPECIALTIES INC. et al. | Institution Denied | 2015-10-09 | — |
| IPR2016-00111 | 8895756 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2015-11-02 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-07-17 | Terminated 2020-07-31 | — | |
| D. Del. | 2017-08-16 | Terminated 2020-07-06 | — | |
Cephalon Inc. v. Sun Pharma Global FZE et al 2 patentsANDA 205653bendamustine hydrochloride | D. Del. | 2013-12-26 | Terminated 2015-03-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hahn Loeser and Parks LLP FDA-2018-P-0339 · 6 docket documents Hahn Loeser & Parks LLP filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Bendamustine Hydrochloride for Injection at 200 mg/vial suitable for submission in an Abbreviated New Drug Application, with the listed drug being | Other | 2018-01-24 | Open | Hahn Loeser and Parks LLP |
Citizen Petition from Teva Pharmaceutical Industries, Ltd. FDA-2015-P-3980 · 19 docket documents Teva Pharmaceutical Industries, Ltd. filed this petition under section 21 USC 355(q) on behalf of its subsidiary Cephalon, Inc., requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing Treanda (bendamustine hydrochloride) before May 1, 2016, if the prop | 505(q) | 2015-10-30 | Denied | Teva Pharmaceutical Industries, Ltd. |
Citizen Petition from Teva Pharmaceuticals (Cephalon, Inc) FDA-2015-P-1431 · 24 docket documents Teva Pharmaceuticals submitted this citizen petition under section 355(q) on behalf of its subsidiary Cephalon, requesting that FDA not approve any abbreviated new drug application for bendamustine (Treanda) referencing the chronic lymphocytic leukemia indication until expiration of the drug's orpha | 505(q) Stay Request | 2015-04-30 | Denied | Teva Pharmaceuticals (Cephalon, Inc) |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0769 · 4 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Bendamustine Hydrochloride for Injection at 200 mg/vial suitable for submission in an Abbreviated New Drug Application, with the listed drug bei | Other | 2013-07-12 | Denied | — |
Center for Medicine in the Public Interest - Citizen Petition FDA-2013-P-0693 · 3 docket documents The Center for Medicine in the Public Interest filed this citizen petition pursuant to 21 CFR Section 10.30 requesting that the FDA refrain from approving any NDA, NDA submitted under section 505(b)(2), or sNDA for a liquid bendamustine formulation (Treanda LQ) until safety conditions are satisfied, | 505(q) Stay Request | 2013-06-19 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8436190 | Oct 26, 2030PED: Apr 26, 2031 | PED | — | Yes | — | — |
| 8445524 | Mar 26, 2029PED: Sep 26, 2029 | PED | Yes | Yes | — | |
| 8609863 | Jan 12, 2026PED: Jul 12, 2026 | PED | — | Yes | — | — |
| 8669279 | Mar 26, 2029PED: Sep 26, 2029 | PED | — | Yes | — | |
| 8791270 | Jan 12, 2026PED: Jul 12, 2026 | PED | — | Yes | — | |
| 8883836 | Mar 26, 2029PED: Sep 26, 2029 | PED | — | Yes | — | |
| 8895756 | Jan 12, 2026PED: Jul 12, 2026 | PED | — | Yes | — | — |
| 9533955 | Mar 26, 2029PED: Sep 26, 2029 | PED | — | Yes | — |