FDA Orange Book
Generic for Imbruvica
Imbruvica contains ibrutinib. 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 Imbruvica is ibrutinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 7 Imbruvica products the Orange Book lists.
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Imbruvica products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 140MG | Marketed (Rx) | AB | 1 | AB |
| capsule, oral | 70MG | Marketed (Rx) | None | 0 | None |
| suspension, oral | 70MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 140MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 280MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 420MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 560MG | Discontinued | None | 0 | None |
NDA 205552, 217003, 210563, held by PHARMACYCLICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ibrutinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 211182 | AB (A-rated, therapeutically equivalent) | September 8, 2026 | 140MG |
Imbruvica patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8952015 | December 28, 2026 | Method of use | U-1650 | 205552 |
| 8952015 | December 28, 2026 | Method of use | U-1946 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-1946 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-1491 | 205552 |
| 8703780 | December 28, 2026 | Method of use | U-1491 | 205552 |
| 8476284 | December 28, 2026 | Method of use | U-1946 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-1650 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-2241 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-2242 | 205552 |
| 8476284 | December 28, 2026 | Method of use | U-1650 | 205552 |
| 8952015 | December 28, 2026 | Method of use | U-1491 | 205552 |
| 8497277 | December 28, 2026 | Method of use | U-3422 | 205552 |
| 8735403 | December 28, 2026 | Drug substance, Drug product | None | 205552 |
| 7514444 | December 28, 2026 | Drug substance, Drug product | None | 205552 |
| 8957079 | December 28, 2026 | Drug substance, Drug product | None | 205552 |
| 9181257 | December 28, 2026 | Drug substance | None | 205552 |
| 8754091 | December 28, 2026 | Drug product | None | 205552 |
| 8697711 | December 28, 2026 | Drug substance, Drug product | None | 205552 |
| 8703780 | December 28, 2026 | Method of use | U-2666 | 217003 |
| 8703780 | December 28, 2026 | Method of use | U-3842 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-2666 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-3842 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-3843 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-3844 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-3845 | 217003 |
| 8476284 | December 28, 2026 | Method of use | U-3843 | 217003 |
| 8476284 | December 28, 2026 | Method of use | U-3844 | 217003 |
| 8476284 | December 28, 2026 | Method of use | U-3845 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-3842 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-3843 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-3845 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-3844 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-2666 | 217003 |
| 8497277 | December 28, 2026 | Method of use | U-2970 | 217003 |
| 8952015 | December 28, 2026 | Method of use | U-2241 | 210563 |
| 8952015 | December 28, 2026 | Method of use | U-2242 | 210563 |
| 8703780 | December 28, 2026 | Method of use | U-2242 | 210563 |
| 8476284 | December 28, 2026 | Method of use | U-2241 | 210563 |
| 8952015 | December 28, 2026 | Method of use | U-1456 | 210563 |
| 8952015 | December 28, 2026 | Method of use | U-1947 | 210563 |
| 8476284 | December 28, 2026 | Method of use | U-1456 | 210563 |
| 8497277 | December 28, 2026 | Method of use | U-1947 | 210563 |
| 8476284 | December 28, 2026 | Method of use | U-1947 | 210563 |
| 8497277 | December 28, 2026 | Method of use | U-1456 | 210563 |
| 8563563 | April 26, 2027 | Method of use | U-2219 | 205552 |
| 8563563 | April 26, 2027 | Method of use | U-1946 | 205552 |
| 8563563 | April 26, 2027 | Method of use | U-1650 | 205552 |
| 8563563 | April 26, 2027 | Method of use | U-1491 | 205552 |
| 8563563 | April 26, 2027 | Method of use | U-3844 | 217003 |
| 8563563 | April 26, 2027 | Method of use | U-3843 | 217003 |
| 8563563 | April 26, 2027 | Method of use | U-3842 | 217003 |
| 8563563 | April 26, 2027 | Method of use | U-2666 | 217003 |
| 8563563 | April 26, 2027 | Method of use | U-3845 | 217003 |
| 8563563 | April 26, 2027 | Method of use | U-2242 | 210563 |
| 8563563 | April 26, 2027 | Method of use | U-2241 | 210563 |
| 7514444*PED | June 28, 2027 | Method of use | None | 205552 |
| 8476284*PED | June 28, 2027 | Method of use | None | 205552 |
| 8497277*PED | June 28, 2027 | Method of use | None | 205552 |
| 8703780*PED | June 28, 2027 | Method of use | None | 205552 |
| 8735403*PED | June 28, 2027 | Method of use | None | 205552 |
Showing 60 of 192 listed patents.
Imbruvica exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | August 24, 2025 | 205552 |
| NP | New product | August 24, 2025 | 217003 |
| PED | Pediatric exclusivity | February 24, 2026 | 205552 |
| ODE-405 | Orphan drug exclusivity | August 24, 2029 | 205552 |
| PED | Pediatric exclusivity | February 24, 2030 | 205552 |
Imbruvica NDC codes
Questions
Is there a generic for Imbruvica?
Yes. The generic name for Imbruvica is ibrutinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 7 Imbruvica products the Orange Book lists.
What is the generic name for Imbruvica?
The active ingredient in Imbruvica is ibrutinib, per the FDA Orange Book.
When does the Imbruvica patent expire?
The last patent listed for Imbruvica in the Orange Book expires June 14, 2039. 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.