Zohydro Er

(Hydrocodone Bitartrate)

Small molecule

Teva

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Moderate Hepatic Impairment1 trial

A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

Completed·CCephalon·Phase 1·NCT01319279·16 enrolled

Renal Impairment1 trial

A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment

Completed·CCephalon·Phase 1·NCT01319266·55 enrolled

Drug Interactions1 trial

Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate

Completed·RReckitt Benckiser LLC·Phase 1·NCT03642873·24 enrolled

Chronic pain1 trial

Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

Completed·ZZogenix, Inc.·Phase 3·NCT01115569·424 enrolled

Low back pain1 trial

Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

Completed·ZZogenix, Inc.·Phase 3·NCT01081912·510 enrolled

1 more indication

Unspecified1 trial

A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers

Completed·QQuivive Pharma, Inc.·Phase 1·NCT06585163·8 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 25, 2013

ZOHYDRO ER

NDA NDA202880

Nov 20, 2014

HYSINGLA ER

NDA NDA206627

Jan 17, 2017

VANTRELA ER

NDA NDA207975

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Hydrocodone Bitartrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hydrocodone Bitartrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA207975). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Zohydro Er. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Teva

Patent Landscape[4]

Patent Cliff

Aug 24, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9770416Aug 24, 2027

9545380Aug 24, 2027

9492391Aug 24, 2027

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32 more patents

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