DICLOFENAC POTASSIUM | N022165 | ASSERTIO SPECIALTY PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| N.D. Ill. | 2020-08-27 | Terminated 2021-03-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition for Reconsideration from Pharmobedient Consulting, LLC FDA-2024-P-4134 · 11 docket documents Pharmobedient Consulting, LLC filed this petition for reconsideration requesting FDA approval of a suitability petition to submit an ANDA for Diclofenac Potassium Tablets at 37.5 mg strength, a dose different from the Reference Listed Drug Cataflam at 25 mg and 50 mg strengths. The FDA had denied th | Suitability | 2025-03-20 | Denied | — |
Amendment for Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2779 · 12 docket documents Hyman, Phelps & McNamara, P.C. filed an amendment for a suitability petition regarding diclofenac potassium tablets in three strengths (12.5 mg, 25 mg, and 50 mg), which are indicated for treatment of primary dysmenorrhea, mild to moderate pain, osteoarthritis, and rheumatoid arthritis. The petition | Suitability | 2024-07-02 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 1 current Orange Book entry for ZIPSOR Capsules re Suitability Pet... FDA-2023-P-4975 · 8 docket documents # Cannot Complete Summary I cannot provide the requested summary because the text provided does not contain the actual petition content. The material shown only includes a title and reference line indicating this is an attachment related to a suitability petition for ZIPSOR Capsules filed by Hyman, | Suitability | 2023-11-13 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 1 - Diclofenac Potassium Tablets, USP 12.5 mg RE: Suitability Peti... FDA-2023-P-4464 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Diclofenac Potassium Tablets, USP 12.5 mg, seeking a determination of regulatory suitability for the drug product under FDA's abbreviated new drug application (ANDA) pathway. | Suitability | 2023-10-30 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 2 - ZIPSOR- diclofenac potassium capsule, liquid filled RE Suitabi... FDA-2023-P-4659 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding ZIPSOR, a liquid-filled capsule formulation of diclofenac potassium, requesting a suitability determination for the drug product as part of the regulatory approval process. | Suitability | 2023-10-23 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 2 Prescribing Information for CATAFLAM re Suitability Petition fro... FDA-2023-P-4444 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a petition regarding the prescribing information for CATAFLAM, a nonsteroidal anti-inflammatory drug. The petition addresses suitability matters related to the product's labeling and prescribing information requirements. | Suitability | 2023-10-11 | Granted | Hyman, Phelps & McNamara, P.C. |
Attachment 2 DICLOFENAC POTASSIUM re Suitability Petition from Pharmobedient ... FDA-2023-P-4282 · 12 docket documents Pharmobedient Consulting, LLC filed a suitability petition regarding diclofenac potassium, requesting that the FDA determine the suitability of this active pharmaceutical ingredient for use in drug products and establish appropriate regulatory pathways for its approval. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Attachment 1 Current Orange Book entry for CATAFLAM Tablets, 25 mg and 50 mg ... FDA-2023-P-0174 · 6 docket documents Hyman Phelps and McNamara PC filed a petition requesting that the FDA reconsider the Orange Book suitability status of CATAFLAM tablets in 25 mg and 50 mg strengths. The petition challenges the current regulatory classification of these diclofenac potassium products to determine whether they remain | Suitability | 2023-01-18 | Withdrawn | Hyman Phelps and McNamara PC |
Attachment 2 - DICLOFENAC POTASSIUM TABLETS USP, 50 mg RE Suitability Petitio... FDA-2022-P-0052 · 9 docket documents Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a petition requesting a suitability determination for diclofenac potassium tablets USP 50 mg to establish reference standards for regulatory purposes under an ANDA submission pathway for generic drug approval. | Suitability | 2022-01-06 | Withdrawn | Amici Pharmaceuticals LLC |
Attachment 1 - CATAFLAM - Discontinued Drug Product List RE Suitability Petit... FDA-2021-P-0509 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Cataflam, requesting that the FDA consider the drug's inclusion on the Discontinued Drug Product List or make a determination regarding its regulatory status and suitability for continued marketing or approval of generic versions. | Suitability | 2021-05-26 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from The Weinberg Group, Inc. FDA-2003-P-0127 · 4 docket documents The Weinberg Group, Inc. filed a suitability petition requesting that the FDA declare Diclofenac Potassium Capsules 25 mg suitable for submission as an ANDA, referencing the approved but discontinued Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142), with the proposed product differing only | Other | 2009-12-17 | Withdrawn | The Weinberg Group, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$12.11
per ea
Lowest NADAC/Unit
$12.11
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69315050609DICLOFENAC POT 50 MG POWDR PKT | $12.11 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.