FDA Orange Book · active-ingredient family
Alogliptin benzoate; metformin hydrochloride
Alogliptin benzoate; metformin hydrochloride: 1 brand, 0 generics; first approved Jan 25, 2013; on patent until Jun 27, 2028.
On patent2 exclusivity periods
Generic status & protection
Protected until Jun 27, 2028 (earliest listed patent expiry).
Earliest patent expiry Jun 27, 2028Latest exclusivity ends Jul 27, 2026
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Jun 27, 2028
in 2 yr
Originator applications
Brand (NDA) products
TAKEDA PHARMS USANDA 20341420132 strengths
TAKEDA PHARMS USANDA 20341420132 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 12.5MG BASE;500MG | TABLET | ORAL | Rx | — |
| EQ 12.5MG BASE;1GM | TABLET | ORAL | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- M-300New use / labeling-change exclusivity (3 years)
Jul 27, 2026
in 14 d
- M-300New use / labeling-change exclusivity (3 years)
Jul 27, 2026
in 14 d
Orange Book patent file
Listed patents
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7807689 | Jun 27, 2028 | in 2 yr | SubstanceProductU-1337 |
| 8900638 | May 24, 2029 | in 2 yr 11 mo | Product |
FDA approval span
Approval history
First approval
Jan 25, 2013
13 yr 8 mo ago
Most recent approval
Jan 25, 2013
13 yr 8 mo ago
All 1 application were approved in 2013.
Brand (NDA) 1100%
Generic (ANDA) 00%
Alogliptin benzoate; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
