MORPHINE SULFATE generics — when can they launch?
MORPHINE SULFATE (MORPHINE SULFATE) · · 71 active US patents · 0 expired
Where MORPHINE SULFATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for MORPHINE SULFATE expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Formulation — 42 patents
- Method of Use — 29 patents
FDA U-codes carved out by MORPHINE SULFATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1510 | (no description) |
U-1640 | (no description) |
U-1556 | (no description) |
U-43 | (no description) |
U-55 | (no description) |
Sample patent estate
Showing 6 of 71 active US patents. View full estate on the MORPHINE SULFATE drug page →
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This patent protects a multi-layer pharmaceutical composition that includes an opioid antagonist and an opioid agonist, such as morphine sulfate, separated by a seal coat.USPTO title: Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
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This patent protects a pharmaceutical composition that combines an antagonist, an agonist, a seal coat, and a sequestering polymer in a single unit.USPTO title: Pharmaceutical compositions for the deterrence and/or prevention of abuse
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This patent protects a pharmaceutical composition that combines an antagonist, an agonist, a seal coat, and a sequestering polymer in a single unit.USPTO title: Pharmaceutical compositions
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This patent protects a method of manufacturing a pharmaceutical composition that includes an antagonist, an agonist, a seal coat, and a sequestering polymer in a single unit.USPTO title: Pharmaceutical composition
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This patent protects a pharmaceutical composition that combines an antagonist, an agonist, a seal coat, and a sequestering polymer in a single unit.USPTO title: Pharmaceutical compositions
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This patent protects a multi-layer pharmaceutical composition that includes an opioid antagonist and an opioid agonist, such as morphine sulfate, separated by a seal coat.USPTO title: Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Sources
- FDA Orange Book — patents listed against MORPHINE SULFATE (NDA filed 1984)
- MORPHINE SULFATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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