Sandimmune generics — when can they launch?
Sandimmune (cyclosporine) · Novartis AG (originally Sandoz) · 17 active US patents · 5 expired
Where Sandimmune sits in the generic timeline
Imminent generic cliff: earliest active US patent for Sandimmune 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 — 10 patents
- Method of Use — 7 patents
FDA U-codes carved out by Sandimmune 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-1483 | (no description) |
U-3627 | (no description) |
U-1900 | (no description) |
Sample patent estate
Showing 6 of 17 active US patents. View full estate on the Sandimmune drug page →
-
This patent protects a well-tolerated oil-in-water emulsion for delivering hydrophobic ingredients, such as pharmaceutical drugs, with a net positive charge.USPTO title: Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential
-
This patent protects compositions containing quaternary ammonium compounds used in ophthalmic oil-in-water formulations.USPTO title: Compositions containing quaternary ammonium compounds
-
This patent protects novel pharmaceutical compositions for treating dry eye syndrome that include semifluorinated alkanes and macrolide immunosuppressants.USPTO title: Pharmaceutical composition for treatment of dry eye syndrome
-
This patent protects a dispensing device for liquid media with a housing, reservoir, and cap that protects the outlet opening and closes the inlet opening in a gas-tight manner.USPTO title: Dispensing device
-
This patent protects a dispensing device for dispensing liquid media, such as a medication like Sandimmune, with a flow brake feature.USPTO title: Dispensing device
-
This patent protects formulations for topical administration, such as ophthalmic solutions, and methods of using these formulations to treat or prevent diseases or conditions.USPTO title: Topical aqueous nanomicellar, ophthalmic solutions and uses thereof
Sources
- FDA Orange Book — patents listed against Sandimmune (NDA filed 1983)
- Sandimmune drug profile — full patent estate, indications, clinical trials, pricing
- Novartis AG (originally Sandoz) patent portfolio
- 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.
Get generic entry alerts
Free Pharma CI alerts on Sandimmune — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →