Tegretol generics — when can they launch?
Tegretol (carbamazepine) · Novartis AG (originally Geigy) · 7 active US patents · 0 expired
Where Tegretol sits in the generic timeline
Imminent generic cliff: earliest active US patent for Tegretol expires in 2028 (~2 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 — 6 patents
- Method of Use — 1 patent
FDA U-codes carved out by Tegretol 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-2004 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Tegretol drug page →
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This patent protects a formulation of carbamazepine (Tegretol) that can be administered parenterally using a carbamazepine-cyclodextrin inclusion complex.USPTO title: Parenteral carbamazepine formulation
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This patent protects a formulation of carbamazepine (Tegretol) in the form of a parenteral carbamazepine-cyclodextrin inclusion complex.USPTO title: Parenteral carbamazepine formulation
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them, particularly in relation to a specific absorption measurement.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, particularly in relation to a specific absorption measurement.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects compositions of sulfoalkyl ether cyclodextrin with less than 100 ppm of phosphate that minimize degradation of certain drugs, such as Tegretol, when exposed to UV light.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects low-chloride alkylated cyclodextrin compositions and processes for preparing and using them.USPTO title: Alkylated cyclodextrin compositions and processes for preparing and using the same
Sources
- FDA Orange Book — patents listed against Tegretol (NDA filed 1968)
- Tegretol drug profile — full patent estate, indications, clinical trials, pricing
- Novartis AG (originally Geigy) patent portfolio
- Patent cliff 2028 — 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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