FDA Orange Book · active-ingredient family
Pomalidomide
Pomalidomide: 1 brand, 11 generics; first approved Feb 08, 2013; generic available.
Generic available20 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
6
Next patent expiry
May 19, 2030
in 3 yr 9 mo
Brand (NDA) products
Originator applications
- POMALYSTRLDBRISTOLNDA 20402620134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB
Generic (ANDA) products (11)
Abbreviated applications
- POMALIDOMIDEMSNANDA 21024520263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDECIPLAANDA 21971820264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDEDR REDDYSANDA 21323420264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDESANDOZANDA 22074120264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDESPILANDA 21023220264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDEHETERO LABS LTD VANDA 21023620244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDEAPOTEXANDA 21016420244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDETEVA PHARMS USAANDA 20995620224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDEMYLANANDA 21027520224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Discontinued — 2MG CAPSULE ORAL Discontinued — 3MG CAPSULE ORAL Discontinued — 4MG CAPSULE ORAL Discontinued — - POMALIDOMIDEBRECKENRIDGEANDA 21011120204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB - POMALIDOMIDEEUGIA PHARMAANDA 21024920204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx AB 2MG CAPSULE ORAL Rx AB 3MG CAPSULE ORAL Rx AB 4MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- PCPatent-challenge (180-day generic) exclusivity
24 d ago
- PCPatent-challenge (180-day generic) exclusivity
24 d ago
- PCPatent-challenge (180-day generic) exclusivity
24 d ago
- PCPatent-challenge (180-day generic) exclusivity
24 d ago
- ODE-296Orphan-drug exclusivity (7 years)
in 8 mo
- ODE-297Orphan-drug exclusivity (7 years)
in 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- ODE-296Orphan-drug exclusivity (7 years)
in 8 mo
- ODE-297Orphan-drug exclusivity (7 years)
in 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- ODE-296Orphan-drug exclusivity (7 years)
in 8 mo
- ODE-297Orphan-drug exclusivity (7 years)
in 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- ODE-296Orphan-drug exclusivity (7 years)
in 8 mo
- ODE-297Orphan-drug exclusivity (7 years)
in 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 2 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10555939 | in 3 yr 9 mo | Product | |
| 9993467 | in 3 yr 9 mo | Product | |
| 9993467*PED | in 4 yr 3 mo | ||
| 10555939*PED | in 4 yr 3 mo | ||
| 8828427 | in 4 yr 10 mo | SubstanceProduct | |
| 8828427*PED | in 5 yr 4 mo |
Approval history
FDA approval span
First approval
13 yr 10 mo ago
Most recent approval
20 d ago
Approvals span 2013–2026 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Pomalidomide: 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.
