MELPHALAN HYDROCHLORIDE generics — when can they launch?
MELPHALAN HYDROCHLORIDE (MELPHALAN HYDROCHLORIDE) · · 18 active US patents · 0 expired
Where MELPHALAN HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for MELPHALAN HYDROCHLORIDE expires in 2029 (~3 years 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 — 15 patents
- Method of Use — 3 patents
FDA U-codes carved out by MELPHALAN HYDROCHLORIDE 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-3086 | (no description) |
U-3675 | (no description) |
U-3680 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the MELPHALAN HYDROCHLORIDE drug page →
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects pharmaceutical compositions containing a nitrogen mustard and a cyclodextrin derivative, and methods for making and using them.USPTO title: Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
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This patent protects pharmaceutical compositions containing a nitrogen mustard and a cyclodextrin derivative, and methods for making and using them.USPTO title: Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
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This patent protects pharmaceutical compositions of melphalan and a cyclodextrin derivative, and methods of making and using these compositions.USPTO title: Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
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This patent protects an apparatus and methods for removing chemotherapy compounds, such as melphalan hydrochloride, from blood.USPTO title: Apparatus for removing chemotherapy compounds from blood
Sources
- FDA Orange Book — patents listed against MELPHALAN HYDROCHLORIDE (NDA filed 1992)
- MELPHALAN HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2029 — 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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