FDA Orange Book
Generic for Pomalyst
Pomalyst contains pomalidomide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Pomalyst is pomalidomide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Pomalyst products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1MG | Marketed (Rx) | AB | 9 | AB |
| capsule, oral | 2MG | Marketed (Rx) | AB | 10 | AB |
| capsule, oral | 3MG | Marketed (Rx) | AB | 10 | AB |
| capsule, oral | 4MG | Marketed (Rx) | AB | 10 | AB |
NDA 204026, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pomalidomide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BRECKENRIDGE PHARMACEUTICAL INC | 210111 | AB (A-rated, therapeutically equivalent) | October 30, 2020 | 1MG, 2MG, 3MG, 4MG |
| EUGIA PHARMA SPECIALITIES LTD | 210249 | AB (A-rated, therapeutically equivalent) | October 30, 2020 | 1MG, 2MG, 3MG, 4MG |
| TEVA PHARMACEUTICALS USA INC | 209956 | AB (A-rated, therapeutically equivalent) | May 4, 2022 | 1MG, 2MG, 3MG, 4MG |
| APOTEX INC | 210164 | AB (A-rated, therapeutically equivalent) | June 11, 2024 | 1MG, 2MG, 3MG, 4MG |
| HETERO LABS LTD UNIT V | 210236 | AB (A-rated, therapeutically equivalent) | September 26, 2024 | 1MG, 2MG, 3MG, 4MG |
| CIPLA LTD | 219718 | AB (A-rated, therapeutically equivalent) | August 31, 2026 | 1MG, 2MG, 3MG, 4MG |
| DR REDDYS LABORATORIES LTD | 213234 | AB (A-rated, therapeutically equivalent) | August 31, 2026 | 1MG, 2MG, 3MG, 4MG |
| SANDOZ INC | 220741 | AB (A-rated, therapeutically equivalent) | August 31, 2026 | 1MG, 2MG, 3MG, 4MG |
| SUN PHARMA INDUSTRIES LTD | 210232 | AB (A-rated, therapeutically equivalent) | August 31, 2026 | 1MG, 2MG, 3MG, 4MG |
| MSN LABORATORIES PRIVATE LTD | 210245 | AB (A-rated, therapeutically equivalent) | September 2, 2026 | 2MG, 3MG, 4MG |
Pomalyst patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10555939 | May 19, 2030 | Drug product | None | 204026 |
| 9993467 | May 19, 2030 | Drug product | None | 204026 |
| 9993467*PED | November 19, 2030 | Method of use | None | 204026 |
| 10555939*PED | November 19, 2030 | Method of use | None | 204026 |
| 8828427 | June 21, 2031 | Drug substance, Drug product | None | 204026 |
| 8828427*PED | December 21, 2031 | Method of use | None | 204026 |
Pomalyst exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-296 | Orphan drug exclusivity | May 14, 2027 | 204026 |
| ODE-297 | Orphan drug exclusivity | May 14, 2027 | 204026 |
| PED | Pediatric exclusivity | November 14, 2027 | 204026 |
Pomalyst NDC codes
Questions
Is there a generic for Pomalyst?
Yes. The generic name for Pomalyst is pomalidomide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Pomalyst?
The active ingredient in Pomalyst is pomalidomide, per the FDA Orange Book.
When does the Pomalyst patent expire?
The last patent listed for Pomalyst in the Orange Book expires December 21, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.