HYDROCODONE BITARTRATE | N206627 | KNOA PHARMA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Purdue Pharma L.P. et al v. Alvogen Pine Brook, LLC et al 5 patentsANDA 208269, 208389hydrocodone bitartrate | D. Del. | 2017-08-11 | Terminated 2018-04-24 | — |
| D. Del. | 2016-01-20 | Terminated 2018-04-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmacists Planning Services, Inc. FDA-2013-P-1606 Pharmacists Planning Services, Inc., in conjunction with the National Coalition Against Prescription Drug Abuse and other pharmacy organizations, filed a citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue federal regulations requiring all hydrocodone schedule II | Other | 2014-01-13 | Partially Denied | Pharmacists Planning Services |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 | Other | 2011-05-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8808740 | Dec 21, 2031 | — | — | Yes | — | |
| 9084816 | Aug 24, 2027 | — | — | Yes | — | — |
| 9095614 | Aug 24, 2027 | — | — | — | — | |
| 9095615 | Aug 24, 2027 | — | — | Yes | — | — |
| 9486412 | Aug 24, 2027 | — | — | Yes | — | — |
| 9486413 | Aug 24, 2027 | — | — | Yes | — | — |
| 9492389 | Aug 24, 2027 | — | — | Yes | — | — |
| 9492390 | Aug 24, 2027 | — | — | — | — | |
| 9492391 | Aug 24, 2027 | — | — | — | — | |
| 9545380 | Aug 24, 2027 | — | — | — | — | |
| 9572779 | Dec 21, 2031 | — | — | Yes | — | — |
| 9750703 | Dec 21, 2031 | — | — | Yes | — | — |
| 9763933 | Aug 24, 2027 | — | — | Yes | — | — |
| 9770416 | Aug 24, 2027 | — | — | Yes | — | — |
| 9775809 | Aug 24, 2027 | — | — | Yes | — | — |
| 9861584 | Dec 21, 2031 | — | — | Yes | — | — |
| 9872837 | Dec 21, 2031 | — | — | Yes | — | — |
| 11304908 | Aug 24, 2027 | — | — | Yes | — | — |
| 11304909 | Aug 24, 2027 | — | — | — | — |
KNOA PHARMA LLC became the applicant of record for Hysingla ER (hydrocodone bitartrate) NDA 206627, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
HYSINGLA ER (hydrocodone bitartrate) applicant changed from Purdue Pharma LP to KNOA Pharma LLC for NDA 206627.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
Hydrocodone bitartrate (Hysingla ER) applicant changed from Purdue Pharma LP to KNOA Pharma LLC for NDA 206627.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA Pharma became the applicant of record for Hysingla ER (hydrocodone bitartrate) NDA 206627, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA PHARMA LLC became the applicant of record for Hysingla ER (hydrocodone bitartrate) NDA 206627, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA Pharma replaces Purdue Pharma LP as the applicant for Hysingla ER (hydrocodone bitartrate) NDA 206627.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA PHARMA LLC replaced PURDUE PHARMA LP as the NDA 206627 applicant for Hysingla ER (hydrocodone bitartrate).
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
HYSINGLA ER (hydrocodone bitartrate) applicant changed from Purdue Pharma LP to Knoa Pharma.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA PHARMA became the applicant for Hysingla ER (hydrocodone bitartrate) NDA 206627, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma assumed ownership of the Hysingla ER (hydrocodone bitartrate) NDA from Purdue Pharma LP, as reflected in the product record update.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma replaced Purdue Pharma LP as the applicant for Hysingla ER (hydrocodone bitartrate) NDA 206627, supplement 005.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
HYSINGLA ER (hydrocodone bitartrate) applicant changed from PURDUE PHARMA LP to KNOA PHARMA for NDA 206627.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
Hydrocodone bitartrate (Hysingla ER) applicant changed from Purdue Pharma LP to Knoa Pharma LLC.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA Pharma LLC replaced Purdue Pharma LP as the applicant for Hysingla ER (hydrocodone bitartrate) NDA 206627.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC