IMATINIB MESYLATE | N021588 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation et al v. Wockhardt Bio AG et al 2 patentsANDA 208429imatinib mesylate | D. Del. | 2016-01-26 | Terminated 2016-12-20 | — |
Novartis Pharmaceuticals Corporation et al v. Shilpa Medicare Limited 2 patentsANDA 208302imatinib mesylate | D. Del. | 2015-11-30 | Terminated 2016-07-27 | — |
Novartis Pharmaceuticals Corporation et al v. Natco Pharma Ltd. 2 patentsANDA 207818imatinib mesylate | D. Del. | 2015-10-28 | Terminated 2017-01-04 | — |
Novartis Pharmaceuticals Corporation et al v. Roxane Laboratories, Inc. 2 patentsANDA 207586imatinib mesylate | D. Del. | 2015-10-09 | Terminated 2017-04-05 | — |
Novartis Pharmaceuticals Corporation et al v. Ranbaxy Inc. et al 2 patentsANDA 206723imatinib mesylate | D. Del. | 2014-12-29 | Terminated 2015-10-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Zydus Pharmaceuticals Inc. - Citizen Petition FDA-2013-P-1002 · 3 docket documents Zydus Pharmaceuticals Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Imatinib Mesylate Tablets in a 300 mg strength is suitable for submission in an ANDA, based on the reference listed drug Gleevec | Other | 2013-09-16 | Open | — |
Natco Pharma Limited - Citizen Petition FDA-2012-P-0479 · 2 docket documents Natco Pharma Limited submitted this suitability petition under Section 505(j)(2)(C) on May 8, 2012, requesting FDA approval to file an abbreviated new drug application for Imatinib Oral Solution 400 mg/5mL as a generic version of Gleevec (Imatinib mesylate) tablets, with the change in dosage form fr | Other | 2012-05-14 | Open | — |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2010-P-0360 · 9 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that the FDA determine that Imatinib Mesylate Capsules in strengths of 200 mg, 400 mg, and 600 mg are suitable for submission in an Abbreviated New Drug Applicati | Other | 2010-07-30 | Granted | — |
Hyman Phelps & Mcnamara, P.C, - Citizen Petition FDA-2010-P-0341 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Imatinib Mesylate Tablets in strengths of 50 mg, 200 mg, and 600 mg are suitable for submission in an Abbreviated New Drug Appli | Other | 2010-06-30 | Granted | — |
Hyman Phelps & McNamara, P.C. - Citizen Petition FDA-2010-P-0275 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of a client requesting that the FDA determine whether GLEEVEC imatinib mesylate capsules in 50 mg and 100 mg strengths, approved under NDA No. 21-335 and manufactured by Novartis Pharmaceutical Corp., were voluntarily withdrawn from the ma | 505(q) | 2010-06-14 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.