Intelligence Report · ~10 min read

Levorphanol Tartrate Intelligence Report

Acertis Pharmaceuticals · Pain Management · Opioid · Approved

Type

Asset Intelligence Report

Generated

Jul 23, 2026

Confidence

High Confidence · 89%

Evidence

27 items

Sources

Executive Summary

Synthesized assessment from linked signals, findings, and evidence relationships.

The FDA's acceptance of the supplemental application for Levorphanol Tartrate by Acertis Pharmaceuticals is significant as it positions Acertis to strengthen its foothold in the competitive opioid pain management market. This development necessitates close monitoring of market dynamics and potential responses from other manufacturers. Regulatory context from FDA (FDA AP — LEVORPHANOL TARTRATE (SUPPL)) supports the near-term read. Assessment grounded in 8 ranked evidence items (8 high-relevance).

Key Developments

Material intelligence events ranked by strategic relevance.

watchJun 24, 2026
Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application
Monitor the timeline for approval and any subsequent market entry strategies from Acertis.
View detail
watchJun 24, 2026
Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application
A timeline shift beyond the mid-term would necessitate a reassessment of urgency in competitive strategies.
View detail
watchJun 24, 2026
Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application
Watch for competitor label expansions or pivotal clinical readouts that could heighten competitive pressure in the opioid market.
View detail
watchJun 24, 2026
Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application
This becomes more urgent if Monitor the timeline for approval and any subsequent market entry strategies from Acertis.
View detail
regulatoryJun 24, 2026
FDA AP — AUVELITY (SUPPL)
Application NDA215430. Sponsor: AXSOME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BUPROPION HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE.
View detail
regulatoryJun 24, 2026
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
View detail
regulatoryJun 24, 2026
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
View detail
regulatoryJun 24, 2026
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
Application ANDA074278. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
View detail

Strategic Implications

Portfolio and competitive decisions informed by this intelligence profile.

Portfolio teams should assess the potential market impact and prepare for competitive responses from other opioid manufacturers. The strongest clinical anchor is Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management (ClinicalTrials.gov), weak alignment to signal sub-indication and entities. In rare disease, 8 regulatory and 0 competitive items passed relevance filtering for Acertis Pharmaceuticals. This becomes more urgent if Monitor the timeline for approval and any subsequent market entry strategies from Acertis. Timeline shift beyond mid term would change urgency. A competitor label expansion or pivotal readout in the same sub-indication would increase competitive pressure.

Supporting Evidence

Evidence-backed items with source attribution and confidence disclosure.

FDA AP — LEVORPHANOL TARTRATE (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ORIG)
FDA
Source: FDA
View evidence
FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)
FDA
Source: FDA
View evidence
FDA AP — AUVELITY (SUPPL)
FDA
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
high relevance
Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
high relevance
Application ANDA213906. Sponsor: SUN PHARM INDS INC. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
high relevance
Application ANDA074278. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
high relevance
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
high relevance
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ORIG)
high relevance
Application ANDA204196. Sponsor: SUN PHARM. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE.
Source: FDA
View evidence
FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)
high relevance
Application ANDA218417. Sponsor: AUROBINDO PHARMA LTD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DEXTROMETHORPHAN POLISTIREX.
Source: FDA
View evidence
FDA AP — AUVELITY (SUPPL)
high relevance
Application NDA215430. Sponsor: AXSOME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BUPROPION HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE.
Source: FDA
View evidence

Related Intelligence

Deep links to signals, insights, companies, and assets in the Humanexa graph.

Signals

FDA Accepts Supplement Application for Levorphanol Tartrate by Acertis Pharmaceuticals
Regulatory Approval

Insights

Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application
Pain Management · Opioid

Executive Summary

Key Developments

Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application

Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application

Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application

Acertis Pharmaceuticals Gains Regulatory Momentum with Levorphanol Tartrate Application

FDA AP — AUVELITY (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

Strategic Implications

Supporting Evidence

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ORIG)

FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)

FDA AP — AUVELITY (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ORIG)

FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)

FDA AP — AUVELITY (SUPPL)

Related Intelligence

Signals

Insights