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Levorphanol Tartrate Intelligence Report

Intelligence report

Intelligence Report · ~10 min read

Levorphanol Tartrate Intelligence Report

Sun Pharma · Pain Management · Opioid · Approved

Type

Asset Intelligence Report

Generated

Jul 24, 2026

Confidence

High Confidence · 91%

Evidence

26 items

Sources

20

Executive Summary

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

The FDA's approval of Sun Pharma's ANDA for Levorphanol Tartrate signifies a new entry into the pain management market, which could disrupt existing pricing structures and market shares. Competitors must be vigilant in adjusting their strategies to maintain their positions in this evolving landscape. Regulatory context from FDA (FDA AP — LEVORPHANOL TARTRATE (SUPPL)) supports the near-term read. Assessment grounded in 9 ranked evidence items (8 high-relevance).

Key Developments

Material intelligence events ranked by strategic relevance.

  1. watchJun 28, 2026

    Sun Pharma's Levorphanol Tartrate Approval Disrupts Pain Management Landscape

    Monitor the launch date and market uptake of Sun Pharma's Levorphanol Tartrate.

    View detail
  2. watchJun 28, 2026

    Sun Pharma's Levorphanol Tartrate Approval Disrupts Pain Management Landscape

    Watch for competitive responses, including pricing adjustments and new product launches from other manufacturers.

    View detail
  3. watchJun 28, 2026

    Sun Pharma's Levorphanol Tartrate Approval Disrupts Pain Management Landscape

    Any shifts in regulatory guidance or competitor label expansions in the same sub-indication could heighten competitive pressure.

    View detail
  4. watchJun 28, 2026

    Sun Pharma's Levorphanol Tartrate Approval Disrupts Pain Management Landscape

    This becomes more urgent if Monitor the launch date and market uptake of Sun Pharma's Levorphanol Tartrate, as well as any competitive responses from other manufacturers.

    View detail
  5. regulatoryJun 27, 2026

    FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)

    Application ANDA218417. Sponsor: AUROBINDO PHARMA LTD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DEXTROMETHORPHAN POLISTIREX.

    View detail
  6. regulatoryJun 27, 2026

    FDA AP — BUTORPHANOL TARTRATE (SUPPL)

    Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.

    View detail
  7. regulatoryJun 27, 2026

    FDA AP — BUTORPHANOL TARTRATE (SUPPL)

    Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.

    View detail
  8. regulatoryJun 27, 2026

    FDA AP — LEVORPHANOL TARTRATE (SUPPL)

    Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.

    View detail

Strategic Implications

Portfolio and competitive decisions informed by this intelligence profile.

Strategic consideration for competitors includes adjusting pricing strategies and assessing market entry timing for their own products. The strongest clinical anchor is Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain (ClinicalTrials.gov), weak alignment to signal sub-indication and entities. In rare disease, 8 regulatory and 1 competitive items passed relevance filtering for Sun Pharma. This becomes more urgent if Monitor the launch date and market uptake of Sun Pharma's Levorphanol Tartrate, as well as any competitive responses from other manufacturers. Timeline shift beyond near 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 POLISTIREX (ORIG)

    FDA

    Source: FDA

    View evidence

  • FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)

    FDA

    Source: FDA

    View evidence

  • FDA AP — PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ORIG)

    FDA

    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 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 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 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 — 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 — PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ORIG)

    high relevance

    Application ANDA220869. Sponsor: RUBICON RESEARCH. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE.

    Source: FDA

    View evidence

Related Intelligence

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

Signals

  • FDA Grants AP Status for Levorphanol Tartrate ANDA213906 by Sun Pharma

    Regulatory Approval

Insights

  • Sun Pharma's Levorphanol Tartrate Approval Disrupts Pain Management Landscape

    Pain Management · Opioid

Companies

  • Sun Pharma

    Sponsor

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