Zohydro Er

(Hydrocodone Bitartrate)

Phase 3Small molecule

Teva

Zohydro Er is one of 66 small molecule programs targeting Low back pain. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Low Back PainActive, not recruiting

Chronic PainActive, not recruiting

Low Back PainPhase 3

Active, not recruiting

Chronic PainPhase 3

Active, not recruiting

Competition

Competitive Landscape

237 competitors in Low Back Pain

#DrugCompanyPhaseTrials

Arcoxia

Novartis

Phase 3

1 2

Sympazan

Lundbeck

Phase 3

1 3

Pred Forte

Suboxone

4 5

Keterol

PPamukkale University

Phase 3

3 6

Ultram

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

1 7

Voltaren

CCerimon Pharmaceuticals

Phase 3

1 8

Tanezumab

Pfizer

Phase 3

4 9

Anjeso

Boehringer Ingelheim

Phase 3

1 10

Remicade

OOrganon and Co

Phase 3

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

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

Oral1 trial

Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension

Not yet recruiting·QQuivive Pharma, Inc.·Phase 1·NCT06585163·8 enrolled

Drug Interactions1 trial

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

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

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

1 more indication

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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for Hydrocodone Bitartrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA207975). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zohydro Er. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Teva

Patent Landscape[5]

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

9492390Aug 24, 2027

11304908Aug 24, 2027

32 more patents

9486412Aug 24, 2027

9775809Aug 24, 2027

9095614Aug 24, 2027

11304909Aug 24, 2027

9492389Aug 24, 2027

9084816Aug 24, 2027

9095615Aug 24, 2027

9486413Aug 24, 2027

9216176Sep 13, 2027

9572803Sep 13, 2027

8445018Jul 31, 2029

9572779Dec 21, 2031

9872837Dec 21, 2031

8808740Dec 21, 2031

9750703Dec 21, 2031

9861584Dec 21, 2031

10322120Jul 25, 2033

9265760Jul 25, 2033

9421200Jul 25, 2033

9433619Jul 25, 2033

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9610286Jul 25, 2033

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10028946Jul 25, 2033

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9452163Sep 12, 2034

10092559Sep 12, 2034

9713611Sep 12, 2034

9486451Sep 12, 2034

9132096Sep 12, 2034

Zohydro Er

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic pain1 trial

Oral1 trial

Drug Interactions1 trial

Low back pain1 trial

Renal Impairment1 trial

Moderate Hepatic Impairment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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