FDA Orange Book · active-ingredient family
Empagliflozin
Empagliflozin: 1 brand, 1 generic; first approved Aug 01, 2014; generic available.
Generic available5 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
27
Next patent expiry
Apr 15, 2027
in 6 mo
Brand (NDA) products
Originator applications
- JARDIANCERLDBOEHRINGER INGELHEIMNDA 20462920142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx — 25MG TABLET ORAL Rx —
Generic (ANDA) products (1)
Abbreviated applications
- EMPAGLIFLOZINZYDUS PHARMSANDA 21213820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-922New indication exclusivity (3 years)
18 d ago
- NPPNew patient population exclusivity (3 years)
4 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 2 mo
- NPPNew patient population exclusivity (3 years)
4 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 2 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7713938 | in 6 mo | SubstanceProduct | |
| 7713938*PED | in 1 yr | ||
| 7579449 | in 1 yr 10 mo | Substance | |
| 7579449*PED | in 2 yr 4 mo | ||
| 8551957 | in 3 yr 1 mo | U-1651 | |
| 12115179 | in 3 yr 5 mo | U-4023 | |
| 8551957*PED | in 3 yr 7 mo | ||
| 12115179*PED | in 3 yr 11 mo | ||
| 12527810 | in 6 yr 8 mo | U-4403 | |
| 12527810*PED | in 7 yr 2 mo | ||
| 10258637 | in 7 yr 7 mo | U-2290 | |
| 11090323 | in 7 yr 7 mo | U-3191 | |
| 12433906 | in 7 yr 7 mo | U-4304 | |
| 12263153 | in 7 yr 7 mo | U-4171 | |
| 12427162 | in 7 yr 7 mo | U-4287 | |
| 11666590 | in 7 yr 7 mo | U-3691 | |
| 11833166 | in 7 yr 7 mo | U-3776 | |
| 11813275 | in 7 yr 7 mo | U-3759 | |
| 9949997 | in 7 yr 9 mo | U-2292 | |
| 9949998 | in 7 yr 9 mo | U-2290 | |
| 10258637*PED | in 8 yr 1 mo | ||
| 11813275*PED | in 8 yr 1 mo | ||
| 11833166*PED | in 8 yr 1 mo | ||
| 11090323*PED | in 8 yr 1 mo | ||
| 12433906*PED | in 8 yr 1 mo | ||
| 9949997*PED | in 8 yr 3 mo | ||
| 9949998*PED | in 8 yr 4 mo |
Approval history
FDA approval span
First approval
12 yr 4 mo ago
Most recent approval
4 yr 3 mo ago
Approvals span 2014–2022 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Empagliflozin: 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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