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Lupin Intelligence Report

Intelligence report

Intelligence Report · ~12 min read

Lupin Intelligence Report

Generated from 10 signals · 2 evidence sources

Type

Company Intelligence Report

Generated

Aug 4, 2026

Confidence

Moderate Confidence · 68%

Evidence

55 items

Sources

11

Executive Summary

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

Lupin maintains an active intelligence profile across Respiratory, Bronchodilator, Gastroenterology, H2 Antagonist, Women's Health. 10 signals are linked with 0 investigate-priority items requiring leadership attention. Competitive pressure is low with high portfolio impact. Evidence coverage stands at 68% across 2 tracked sources. Highest-priority development: FDA AP — BUPRENORPHINE HYDROCHLORIDE (SUPPL). Regulatory precedent. Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Lupin; the same agency is already in play for this signal, so precedent weight is higher.

Key Developments

Material intelligence events ranked by strategic relevance.

  1. regulatory

    FDA AP — BUPRENORPHINE HYDROCHLORIDE (SUPPL)

    Regulatory precedent may inform portfolio positioning

    View detail
  2. regulatory

    Wild Arabic Herbs - 729192 - 06/17/2026

    Regulatory precedent may inform portfolio positioning

    View detail
  3. regulatory

    FDA TA — ANDA218552

    Regulatory precedent may inform portfolio positioning

    View detail
  4. regulatory

    FDA AP — CHILDREN'S ZYRTEC HIVES (SUPPL)

    Regulatory precedent may inform portfolio positioning

    View detail
  5. regulatory

    FDA AP — CHILDREN'S ADVIL-FLAVORED (SUPPL)

    Regulatory precedent may inform portfolio positioning

    View detail
  6. regulatory

    FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs

    Regulatory precedent may inform portfolio positioning

    View detail
  7. regulatory

    Ongoing | Cancer Accelerated Approvals

    Regulatory precedent may inform portfolio positioning

    View detail
  8. regulatory

    CDER proposes to withdraw approval of TAVNEOS

    Regulatory precedent may inform portfolio positioning

    View detail
  9. regulatory

    Withdrawn | Cancer Accelerated Approvals

    Regulatory precedent may inform portfolio positioning

    View detail
  10. regulatory

    Oncology (Cancer)/Hematologic Malignancies Approval Notifications

    Regulatory precedent may inform portfolio positioning

    View detail
  11. regulatory

    FDA AP — ADRENALIN (SUPPL)

    Regulatory precedent may inform portfolio positioning

    View detail
  12. regulatory

    FDA AP — TWIRLA (SUPPL)

    Regulatory precedent may inform portfolio positioning

    View detail

Strategic Implications

Portfolio and competitive decisions informed by this intelligence profile.

Opportunity score 660 with buyer quality 4 (Low Priority). Competitive pressure: Low. Portfolio impact: High.

Supporting Evidence

Evidence-backed items with source attribution and confidence disclosure.

  • FDA AP — BUPRENORPHINE HYDROCHLORIDE (SUPPL)

    Moderate Confidence · 77%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Wild Arabic Herbs - 729192 - 06/17/2026

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA TA — ANDA218552

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA AP — CHILDREN'S ZYRTEC HIVES (SUPPL)

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA AP — CHILDREN'S ADVIL-FLAVORED (SUPPL)

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Ongoing | Cancer Accelerated Approvals

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • CDER proposes to withdraw approval of TAVNEOS

    Moderate Confidence · 84%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Withdrawn | Cancer Accelerated Approvals

    Moderate Confidence · 84%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Oncology (Cancer)/Hematologic Malignancies Approval Notifications

    Moderate Confidence · 84%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA AP — ADRENALIN (SUPPL)

    Moderate Confidence · 77%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • FDA AP — TWIRLA (SUPPL)

    Moderate Confidence · 77%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • eCTD Submission Standards for eCTD v3.2.2 and Regional M1

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • eCTD Submission Standards for eCTD v4.0 and Regional M1

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Data Standards Program Strategic Plan and Board

    Moderate Confidence · 66%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

  • Ongoing | Cancer Accelerated Approvals

    Moderate Confidence · 77%

    Regulatory precedent may inform portfolio positioning

    Source: FDA, FDA, Regunera

    View evidence

Related Intelligence

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

Signals

  • Lupin's Lenalidomide ANDA214398 Receives Abbreviated Approval

    Oncology · Immunomodulator

  • Lupin's Glycerol Phenylbutyrate Receives FDA Approval Status

    Metabolic Disorders · Urea Cycle Disorder

  • Lupin's Famotidine ANDA217432 Receives Abbreviated Approval from FDA

    Gastroenterology · H2 Antagonist

  • Lupin's ANDA201446 for Levonorgestrel Receives Standard Review Status

    Women's Health · Contraceptive

  • Lupin's ANDA for Fosaprepitant Dimeglumine Receives AP Status from FDA

    Oncology · Antiemetic

  • Lupin's Doxycycline ANDA204234 Receives AP Status from FDA

    Infectious Disease · Antibiotic

  • Lupin Inc. Submits ANDA for Revefenacin to FDA

    Respiratory · Bronchodilator

  • Lupin's ANDA091440 for Levonorgestrel and Ethinyl Estradiol Receives AP Status

    Women's Health · Contraception

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