FDA Orange Book · active-ingredient family
Apremilast
Apremilast: 2 brands, 13 generics; first approved Mar 21, 2014; generic available.
Generic available22 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
13
Listed patents
11
Next patent expiry
Feb 16, 2028
in 1 yr 6 mo
Brand (NDA) products
Originator applications
- AMGEN INCNDA 2107452025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET, EXTENDED RELEASE ORAL Rx — - OTEZLARLDAMGEN INCNDA 20543720143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB
Generic (ANDA) products (13)
Abbreviated applications
- APREMILASTTORRENTANDA 21183420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTMSNANDA 21188720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - APREMILASTMACLEODS PHARMS LTDANDA 21178820243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTMANKIND PHARMAANDA 21173420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - APREMILASTGLENMARK PHARMS LTDANDA 21167420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTANNORAANDA 21187820233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - APREMILASTAUROBINDO PHARMA LTDANDA 21171620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTDR REDDYSANDA 21175620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTSHILPAANDA 21177420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - APREMILASTTEVA PHARMS USA INCANDA 21189720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTALKEM LABS LTDANDA 21176120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - APREMILASTAMNEALANDA 21178220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - APREMILASTUNICHEMANDA 21181920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-299New use / labeling-change exclusivity (3 years)
22 d ago
- ODE*FDA marketing exclusivity
23 d ago
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- M-299New use / labeling-change exclusivity (3 years)
22 d ago
- NPPNew patient population exclusivity (3 years)
in 9 mo
- ODE-248Orphan-drug exclusivity (7 years)
23 d ago
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- M-299New use / labeling-change exclusivity (3 years)
22 d ago
- NPPNew patient population exclusivity (3 years)
in 9 mo
- ODE-248Orphan-drug exclusivity (7 years)
23 d ago
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- M-299New use / labeling-change exclusivity (3 years)
22 d ago
- NPPNew patient population exclusivity (3 years)
in 9 mo
- ODE-248Orphan-drug exclusivity (7 years)
23 d ago
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 5 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7427638 | in 1 yr 6 mo | SubstanceProduct | |
| 7427638*PED | in 2 yr 1 mo | ||
| 12576034 | in 7 yr 5 mo | ProductU-4291 | |
| 10092541 | in 7 yr 11 mo | U-2659 | |
| 9872854 | in 7 yr 11 mo | U-2232 | |
| 12576034*PED | in 7 yr 11 mo | ||
| 9872854*PED | in 8 yr 5 mo | ||
| 10092541*PED | in 8 yr 5 mo | ||
| 11752129 | in 16 yr | ProductU-4264 | |
| 12427136 | in 16 yr | U-1858 | |
| 11969409 | in 16 yr | Product |
Approval history
FDA approval span
First approval
12 yr 7 mo ago
Most recent approval
1 yr ago
Approvals span 2014–2025 across 15 FDA applications.
Brand (NDA) 213%
Generic (ANDA) 1387%
Apremilast: 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.
