Intelligence Report · ~15 min read

CNS · Cough Suppressant Therapeutic Area Assessment

1 signals · 1 insights · 5 regulatory precedents

Type

Therapeutic Area Assessment

Generated

Jul 24, 2026

Confidence

High Confidence · 88%

Evidence

7 items

Sources

Executive Summary

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

Therapeutic area assessment for CNS · Cough Suppressant integrates 1 signals, 1 executive insights, and 5 regulatory precedents from the Humanexa intelligence graph. 0 portfolio assets maintain indication overlap in this area. Regulatory and competitive dynamics require cross-functional monitoring across linked entities.

Key Developments

Material intelligence events ranked by strategic relevance.

signalJul 4, 2026
Aurobindo Pharma's Dextromethorphan Polistirex Receives AP Status from FDA
Aurobindo Pharma's application for Dextromethorphan Polistirex has received an Abbreviated Approval (AP) status from the FDA.
View detail
regulatoryJul 4, 2026
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
Application ANDA074278. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
View detail
regulatoryJul 4, 2026
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
View detail
regulatoryJul 4, 2026
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
View detail
regulatoryJul 4, 2026
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
View detail
insightJul 4, 2026
Aurobindo Pharma's Regulatory Approval Enhances Competitive Position in Cough Suppressants
Aurobindo Pharma's receipt of Abbreviated Approval (AP) for Dextromethorphan Polistirex signifies a notable regulatory milestone that could shift competitive dynamics in the cough suppressant market. Pharma strategy teams should closely monitor this development to assess its implications on market positioning and competitive responses. Regulatory context from FDA (FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)) supports the near-term read. Assessment grounded in 8 ranked evidence items (8 high-relevance).
View detail

Strategic Implications

Portfolio and competitive decisions informed by this intelligence profile.

Executive insights surface 1 risk-calibrated assessments for portfolio review. 5 Regunera precedents provide regulatory context for pathway and timing decisions. Monitor 1 companies with active signal exposure for competitive and portfolio shifts.

Supporting Evidence

Evidence-backed items with source attribution and confidence disclosure.

FDA AP — LEVORPHANOL TARTRATE (SUPPL)
77%
Application ANDA074278. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
66%
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
66%
Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
66%
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Source: FDA
View evidence
FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)
66%
Application ANDA218417. Sponsor: AUROBINDO PHARMA LTD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DEXTROMETHORPHAN POLISTIREX.
Source: FDA
View evidence
Aurobindo Pharma's Regulatory Approval Enhances Competitive Position in Cough Suppressants
88%
Aurobindo Pharma's receipt of Abbreviated Approval (AP) for Dextromethorphan Polistirex signifies a notable regulatory milestone that could shift competitive dynamics in the cough suppressant market. Pharma strategy teams should closely monitor this development to assess its implications on market positioning and competitive responses. Regulatory context from FDA (FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)) supports the near-term read. Assessment grounded in 8 ranked evidence items (8 high-relevance).
Source: Humanexa Insight
View evidence

Related Intelligence

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

Executive Summary

Key Developments

Aurobindo Pharma's Dextromethorphan Polistirex Receives AP Status from FDA

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

Aurobindo Pharma's Regulatory Approval Enhances Competitive Position in Cough Suppressants

Strategic Implications

Supporting Evidence

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — LEVORPHANOL TARTRATE (SUPPL)

FDA AP — BUTORPHANOL TARTRATE (SUPPL)

FDA AP — DEXTROMETHORPHAN POLISTIREX (ORIG)

Aurobindo Pharma's Regulatory Approval Enhances Competitive Position in Cough Suppressants

Related Intelligence

Signals

Insights

Companies