Viewing data from:

PALLADONE

NDA

HYDROMORPHONE HYDROCHLORIDE | N021044 | PURDUE PHARMA LP

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Kirk Van Rooyan and Barbara Van Rooyan - Citizen Petition FDA-2005-P-0325 · 11 docket documents Kirk Van Rooyan and Barbara Van Rooyan filed this citizen petition under Section 505(b) of the Federal Food, Drug and Cosmetic Act requesting that the FDA temporarily recall and permanently amend approvals for OxyContin (NDA 020553) and Palladone (NDA 021044), specifically seeking chemical reformula	Other	2008-12-22	Partially Denied	—
Purdue Pharma L.P. FDA-2007-P-0003 · 9 docket documents Purdue Pharma L.P. filed this citizen petition regarding Palladone (hydromorphone hydrochloride extended-release capsules) in 12 mg, 16 mg, 24 mg, and 32 mg strengths for opioid-tolerant patients. The document presents the drug label and prescribing information for this Schedule II controlled-releas	Other	2008-05-06	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

153 trials from ClinicalTrials.gov — 2 recruiting, 3 active, 111 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain NCT04296305	Phase 4	Active	M.D. Anderson Cancer Center	84	2020-09-10 → 2027-12-31
Multimodal Analgesia Effect on Post Surgical Patient NCT04240626	Phase 4	Active	University of California, Davis	60	2021-01-20 → 2026-06-24
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery NCT03214510	Phase 3	Active	M.D. Anderson Cancer Center	101	2017-10-04 → 2026-07-31
Spinal Anesthesia For Enhanced Recovery After Liver Surgery NCT03715517	N/A	Recruiting	University of Manitoba	128	2018-10-04 → 2031-12-31
Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery NCT03893734	Phase 4	Recruiting	Endeavor Health	140	2018-05-01 → 2020-12-23
Association Between Body Size and Response to Hydromorphone in ED NCT01675778	Phase 2	Completed	Albert Einstein College of Medicine	174	2011-10 → 2012-12
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery NCT02423876	Phase 3	Completed	University of Wisconsin, Madison	104	2015-03-17 → 2022-01-03
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.NCT02437669	Phase 2	Completed	Columbia University	35	2015-05 → 2018-04
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)NCT00385541	Phase 4	Completed	Columbia University	50	2003-11 → 2007-10
The Discriminative Effects of Tramadol in Humans NCT00499746	Phase 1/2	Completed	National Institute on Drug Abuse (NIDA)	20	2007-11 → 2011-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs6 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

NORAMCO LLCHYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 195612006

SIEGFRIED USA LLCHYDROMORPHONE HYDROCHLORIDE USP

DMF 220822008

SPECGX LLCHYDROMORPHONE HYDROCHLORIDE USP (NP)

DMF 257662012

CHATTEM CHEMICALS INCHYDROMORPHONE HYDROCHLORIDE, USP

DMF 309952016

DIOSYNTH BVInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70111987

TAKEDA PHARMACEUTICAL CO LTDInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70711987

SPECGX LLCInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 72371987

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 163512002

CODY LABORATORIES INCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 288042014

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 319942020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 17, 2014	SUPPL -13	View Letter (PDF)
Sep 27, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 12MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 24, 2004

No patent or exclusivity listings for this strength.

#002 — 16MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 24, 2004

#003 — 24MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 24, 2004

#004 — 32MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 24, 2004