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 |
|---|---|---|---|---|
Acknowledgement Letter to Horizon Pharma Inc FDA-2013-P-1283 Horizon Pharma Inc filed a citizen petition received on October 17, 2013, requesting that the FDA establish bioequivalence for any ANDA listing RAYOS tablets as the reference listed drug. The petition was assigned docket number FDA-2013-P-1283/CP1 and filed on October 25, 2013. | 505(q) | 2013-11-14 | Partially Denied | — |
Horizon Pharma, Inc. - Citizen Petition FDA-2013-P-1283 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 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drug must demonstrate bioequivalence under fed conditions with data showing the generic pr | 505(q) | 2013-09-23 | Withdrawn | — |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 | — | — | — | — |