SAXAGLIPTIN HYDROCHLORIDE generics — when can they launch?
SAXAGLIPTIN HYDROCHLORIDE (SAXAGLIPTIN HYDROCHLORIDE) · · 2 active US patents · 0 expired
Where SAXAGLIPTIN HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for SAXAGLIPTIN HYDROCHLORIDE expires in 2028 (~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 — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the SAXAGLIPTIN HYDROCHLORIDE drug page →
-
This patent protects a coated tablet formulation that includes saxagliptin hydrochloride, a DPP4-inhibitor, and various conventional excipients.USPTO title: Coated tablet formulation and method
-
This patent protects a coated tablet formulation that includes saxagliptin hydrochloride, a DPP4-inhibitor, and various conventional excipients.USPTO title: Coated tablet formulation and method
Sources
- FDA Orange Book — patents listed against SAXAGLIPTIN HYDROCHLORIDE (NDA filed 2009)
- SAXAGLIPTIN HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- 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.
Get generic entry alerts
Free Pharma CI alerts on SAXAGLIPTIN HYDROCHLORIDE — 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 →