METFORMIN HYDROCHLORIDE generics — when can they launch?
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) · · 23 active US patents · 0 expired
Where METFORMIN HYDROCHLORIDE sits in the generic timeline
All listed Orange Book patents for METFORMIN HYDROCHLORIDE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 9 patents
- Method of Use — 7 patents
- Other — 7 patents
FDA U-codes carved out by METFORMIN 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-802 | (no description) |
U-1227 | (no description) |
U-1036 | (no description) |
Sample patent estate
Showing 6 of 23 active US patents. View full estate on the METFORMIN HYDROCHLORIDE drug page →
-
This patent protects a pharmaceutical formulation containing a controlled release component with an antihyperglycemic drug and a thiazolidinedione derivative.USPTO title: Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
-
This patent protects a pharmaceutical formulation containing a controlled release component with an antihyperglycemic drug and a thiazolidinedione derivative.USPTO title: Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
-
This patent protects a pharmaceutical formulation containing a controlled release component with an antihyperglycemic drug and a thiazolidinedione derivative.USPTO title: Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
-
This patent protects a pharmaceutical formulation containing a controlled release component with an antihyperglycemic drug and a thiazolidinedione derivative.USPTO title: Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
-
This patent protects a crystalline monohydrate of the dihydrogenphosphate salt of a dipeptidyl peptidase-IV inhibitor.USPTO title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
-
This patent protects a crystalline monohydrate of the dihydrogenphosphate salt of a dipeptidyl peptidase-IV inhibitor.USPTO title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Sources
- FDA Orange Book — patents listed against METFORMIN HYDROCHLORIDE (NDA filed 1995)
- METFORMIN HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — 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 METFORMIN 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 →