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Lurasidone Hydrochloride Intelligence Report

Intelligence report

Intelligence Report · ~10 min read

Lurasidone Hydrochloride Intelligence Report

Torrent Pharmaceuticals · Psychiatry · Antipsychotic · Approved

Type

Asset Intelligence Report

Generated

Jul 23, 2026

Confidence

Moderate Confidence · 69%

Evidence

27 items

Sources

20

Executive Summary

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

Torrent's receipt of Abbreviated Approval (AP) for Lurasidone Hydrochloride positions the company to enhance its competitive stance in the antipsychotic market. This development necessitates strategic planning for portfolio expansion and pricing adjustments to counteract potential responses from established players. Regulatory context from FDA (FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)) supports the near-term read. Assessment grounded in 21 ranked evidence items (10 high-relevance).

Key Developments

Material intelligence events ranked by strategic relevance.

  1. insightJun 23, 2026

    Torrent Pharmaceuticals Gains Competitive Edge with Lurasidone Hydrochloride Approval

    Intelligence brief refreshed — Torrent's receipt of Abbreviated Approval (AP) for Lurasidone Hydrochloride positions the company to enhance its competitive stance in the antipsychotic market. This development necessitates strategic planning for portfolio expansion and pricing adjustments to counteract potential responses from established players. Regulatory context from FDA (FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)) supports the near-term read. Assessment grounded in 21 ranked evidence items (10 high-relevance).

    View detail
  2. watchJun 23, 2026

    Torrent Pharmaceuticals Gains Competitive Edge with Lurasidone Hydrochloride Approval

    Monitor market entry timelines for Lurasidone Hydrochloride and competitive responses from established players.

    View detail
  3. watchJun 23, 2026

    Torrent Pharmaceuticals Gains Competitive Edge with Lurasidone Hydrochloride Approval

    Any timeline shifts beyond mid-term would necessitate urgent strategic reassessments.

    View detail
  4. watchJun 23, 2026

    Torrent Pharmaceuticals Gains Competitive Edge with Lurasidone Hydrochloride Approval

    A competitor's label expansion or pivotal clinical readout in the same indication could heighten competitive pressure.

    View detail
  5. regulatoryJun 13, 2026

    FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    Application ANDA208002. Sponsor: AMNEAL PHARMS CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    View detail
  6. regulatoryJun 13, 2026

    FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    Application ANDA208052. Sponsor: ZYDUS PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    View detail
  7. regulatoryJun 13, 2026

    FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    Application ANDA208055. Sponsor: TORRENT. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    View detail
  8. regulatoryJun 13, 2026

    FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    Application ANDA208055. Sponsor: TORRENT. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    View detail

Strategic Implications

Portfolio and competitive decisions informed by this intelligence profile.

Strategic consideration for portfolio expansion and pricing strategies in the antipsychotic segment. The strongest clinical anchor is EFFECT OF A DİETİTİAN-SUPERVİSED LOW-FODMAP DİET VERSUS STANDARD WRİTTEN ADVİCE ON GASTROİNTESTİNAL SYMPTOMS AND INFLAMMATORY BİOMARKERS İN IRRİTABLE BOWEL SYNDROME: A RANDOMİZED CONTROLLED TRİAL (ClinicalTrials.gov), moderate corpus alignment. In Psychiatry · Antipsychotic, 7 regulatory and 6 competitive items passed relevance filtering for Torrent Pharmaceuticals. This becomes more urgent if Monitor for market entry timelines and potential competitive responses from established players. 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 — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    FDA

    Source: FDA

    View evidence

  • EFFECT OF A DİETİTİAN-SUPERVİSED LOW-FODMAP DİET VERSUS STANDARD WRİTTEN ADVİCE ON GASTROİNTESTİNAL SYMPTOMS AND INFLAMMATORY BİOMARKERS İN IRRİTABLE BOWEL SYNDROME: A RANDOMİZED CONTROLLED TRİAL

    ClinicalTrials.gov

    Source: ClinicalTrials.gov

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208055. Sponsor: TORRENT. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208052. Sponsor: ZYDUS PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208058. Sponsor: HERITAGE PHARMA AVET. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208028. Sponsor: INVAGEN PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208045. Sponsor: AUROBINDO PHARMA LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208047. Sponsor: DR REDDYS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)

    high relevance

    Application ANDA208055. Sponsor: TORRENT. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.

    Source: FDA

    View evidence

  • EFFECT OF A DİETİTİAN-SUPERVİSED LOW-FODMAP DİET VERSUS STANDARD WRİTTEN ADVİCE ON GASTROİNTESTİNAL SYMPTOMS AND INFLAMMATORY BİOMARKERS İN IRRİTABLE BOWEL SYNDROME: A RANDOMİZED CONTROLLED TRİAL

    medium relevance

    Background: Irritable Bowel Syndrome (IBS) is the most prevalent functional gastrointestinal (GI) pathology among GI disorders. Various dietary interventions, particularly the low-FODMAP diet, are employed to alleviate IBS symptoms. Study Population \& Design: This study will include 78 adult patients, aged 18-65, diagnosed with IBS according to Rome IV criteria at the Biruni University Faculty of Medicine Hospital Gastroenterology Outpatient Clinic.

    Source: ClinicalTrials.gov

    View evidence

Related Intelligence

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

Signals

  • Torrent's Lurasidone Hydrochloride ANDA Receives AP Status from FDA

    Regulatory Approval

Insights

  • Torrent Pharmaceuticals Gains Competitive Edge with Lurasidone Hydrochloride Approval

    Psychiatry · Antipsychotic

Companies

  • Torrent Pharmaceuticals

    Sponsor

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