Therapeutic Area

Opioid

Therapeutic area intelligence for Opioid with 16 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 16
Catalysts: 0
Companies: 9

Companies

Acertis Pharmaceuticals →

Difgen Pharmaceuticals →

Hikma →

Macleods Pharmaceuticals →

Osmotica Pharmaceuticals →

Pharmaceutical Associates →

Protega Pharmaceuticals →

Rhodes Pharmaceuticals →

Sun Pharma →

Assets

Recent signals(16)

RegulatoryJune 24, 2026

FDA Approval for Methadone Hydrochloride by Sun Pharma

The FDA has approved the supplemental application ANDA208305 for Methadone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 24, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride by Osmotica

The FDA has issued an approval status update for ANDA205629 concerning Hydromorphone Hydrochloride.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for Roxicodone by SPECGX LLC

The FDA has accepted a supplemental application for Roxicodone, indicating ongoing regulatory engagement.

RegulatoryJune 24, 2026

FDA Approves Supplement for Methadone Hydrochloride by Hikma

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Hikma.

StrategyJune 24, 2026

FDA Grants Approval for Tramadol Hydrochloride ANDA209404 by Macleods

The FDA has granted approval for ANDA209404, a supplemental application for Tramadol Hydrochloride by Macleods Pharmaceuticals.

StrategyJune 24, 2026

Hikma's Roxicet ANDA089351 Receives Abbreviated Approval from FDA

Hikma's Abbreviated New Drug Application (ANDA) for Roxicet has received approval from the FDA.

RegulatoryJune 24, 2026

FDA Accepts Supplemental Application for Oxycodone Hydrochloride

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by Pharm Assoc.

RegulatoryJune 24, 2026

FDA Accepts Supplement for Codeine Sulfate by Hikma

The FDA has accepted a supplemental application for Codeine Sulfate submitted by Hikma.

RegulatoryJune 24, 2026

FDA grants AP status for Fentanyl-75 supplement by Difgen Pharms

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for a supplement of Fentanyl-75 submitted by Difgen Pharmaceuticals.

RegulatoryJune 24, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Vistapharm LLC.

RegulatoryJune 24, 2026

FDA Accepts Supplemental NDA for Dilaudid by Rhodes Pharmaceuticals

The FDA has accepted a supplemental NDA for Dilaudid, an opioid pain medication.

RegulatoryJune 24, 2026

FDA Accepts Supplemental NDA for QDOLO by Rosemont

The FDA has accepted a supplemental NDA for QDOLO, a tramadol hydrochloride formulation, submitted by Rosemont.

RegulatoryJune 24, 2026

FDA Accepts Supplemental Application for Tramadol Hydrochloride by Rubicon Research

The FDA has accepted a supplemental application for Tramadol Hydrochloride submitted by Rubicon Research.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for RoxyBond (NDA209777)

The FDA has accepted a supplemental application for RoxyBond, an oxycodone hydrochloride formulation.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for Levorphanol Tartrate by Acertis Pharmaceuticals

The FDA has accepted the supplemental application for Levorphanol Tartrate submitted by Acertis Pharmaceuticals.

RegulatoryJune 24, 2026

FDA Approval Status Update for Oxycodone Hydrochloride by Pharmobedient

The FDA has provided an approval status update for ANDA206456, a supplemental application for Oxycodone Hydrochloride submitted by Pharmobedient.

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Indications

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