PREDNISONE | N202020 | HORIZON THERAPEUTICS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
HORIZON PHARMA AG et al v. PAR PHARMACEUTICAL COMPANIES, INC. et al 5 patentsANDA 204700prednisone | D.N.J. | 2013-10-22 | Terminated 2013-12-06 | — |
Horizon Pharma AG et al v. Watson Laboratories, Inc. - Florida et al 5 patentsANDA 204867prednisone | S.D. Fla. | 2013-08-28 | Terminated 2013-09-05 | — |
HORIZON PHARMA AG et al v. WATSON LABORATORIES, INC. - FLORIDA et al 5 patentsANDA 204867prednisone | D.N.J. | 2013-08-26 | Terminated 2016-03-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Horizon Pharma, Inc. - Citizen Petition FDA-2013-P-1283 · 3 docket documents Horizon Pharma, Inc. filed this citizen petition on October 4, 2013, requesting that FDA require any ANDA referencing RAYOS (prednisone) delayed-release tablets 1 mg, 2 mg, or 5 mg as the reference listed drug establish bioequivalence by demonstrating that the generic product has an equivalent lag t | 505(q) | 2013-11-14 | Partially Denied | — |
Horizon Pharma, Inc. - Citizen Petition FDA-2013-P-1082 · 3 docket documents Horizon Pharma, Inc. filed this citizen petition on September 3, 2013, requesting that the FDA require any ANDA referencing NDA No. 202020 for RAYOS (prednisone delayed-release tablets) as the reference listed drug must demonstrate bioequivalence under fed conditions with data showing the generic pr | 505(q) | 2013-09-23 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9504699 | Aug 3, 2027 | — | — | — | — |