Clinical Competition Candidate

EMBEDA

Pain · Chronic pain, opioid-tolerant patients (morphine / naltrexone ER, abuse-deterrent)

EMBEDA carries product and use-code patents, moderate complexity (3/5), and meaningful clinical competition (4/5). The listed expiry window is approximately 40 months away. Active clinical competition may compress the generic entry window.

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LOE window

40months

to latest listed patent expiry (November 7, 2029)

Expiry attractiveness: 4/5

Patent profile

Substance patent (none)

Product / formulation patent (listed)

Use-code patent (listed)

Patent count: 7

Complexity score: 3/5

Clinical competition

Score: 4/5

Active trials linked: 339

Phase 2/3 trials: 72

Higher scores indicate more trial activity for this ingredient — a proxy for competitive generic interest.

Drug overview

Active ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Applicant (NDA holder): ALPHARMA PHARMACEUTICALS LLC

Confidence: High

Market context

Therapeutic area: Pain

Indication: Chronic pain, opioid-tolerant patients (morphine / naltrexone ER, abuse-deterrent)

U.S. market size (est.)< $100M

Estimated U.S. net sales tier. Verify current figures before commercial diligence.