FDA Orange Book
Generic for Bosulif
Bosulif contains bosutinib. 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 Bosulif is bosutinib. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Bosulif products the Orange Book lists.
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Bosulif products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 400MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 500MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 217729, 203341, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bosutinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 209543 | AB (A-rated, therapeutically equivalent) | May 23, 2025 | EQ 100MG BASE, EQ 500MG BASE |
| MSN LABORATORIES PRIVATE LTD | 209624 | AB (A-rated, therapeutically equivalent) | June 12, 2026 | EQ 400MG BASE |
Bosulif patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7417148 | December 11, 2025 | Method of use | U-3707 | 217729 |
| 7417148 | December 11, 2025 | Method of use | U-3708 | 217729 |
| 7919625 | December 11, 2025 | Drug product | None | 217729 |
| 7417148 | December 11, 2025 | Method of use | U-1283 | 203341 |
| 7919625*PED | June 11, 2026 | Method of use | None | 217729 |
| 7417148*PED | June 11, 2026 | Method of use | None | 217729 |
| 7767678 | November 23, 2026 | Drug substance, Drug product | None | 217729 |
| 7767678*PED | May 23, 2027 | Method of use | None | 217729 |
| 11103497 | February 28, 2034 | Method of use | U-3216 | 217729 |
| 11103497 | February 28, 2034 | Method of use | U-3217 | 217729 |
| 11103497*PED | August 28, 2034 | Method of use | None | 217729 |
Bosulif exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | September 26, 2026 | 217729 |
| I-923 | New indication | September 26, 2026 | 203341 |
| PED | Pediatric exclusivity | March 26, 2027 | 217729 |
| ODE-444 | Orphan drug exclusivity | September 26, 2030 | 217729 |
| PED | Pediatric exclusivity | March 26, 2031 | 217729 |
Bosulif NDC codes
Questions
Is there a generic for Bosulif?
Yes. The generic name for Bosulif is bosutinib. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Bosulif products the Orange Book lists.
What is the generic name for Bosulif?
The active ingredient in Bosulif is bosutinib, per the FDA Orange Book.
When does the Bosulif patent expire?
The last patent listed for Bosulif in the Orange Book expires August 28, 2034. 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.