FDA Orange Book
Generic for Erleada
Erleada contains apalutamide. 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 Erleada is apalutamide. 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 2 Erleada products the Orange Book lists.
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Erleada products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 240MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 60MG | Marketed (Rx) | AB | 1 | AB |
NDA 210951, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic apalutamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS LIFESCIENCES GLOBAL FZE | 217113 | AB (A-rated, therapeutically equivalent) | March 17, 2025 | 60MG |
Erleada patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8802689 | March 27, 2027 | Method of use | U-2237 | 210951 |
| 8802689 | March 27, 2027 | Method of use | U-2624 | 210951 |
| 9987261 | March 27, 2027 | Drug product | None | 210951 |
| 9388159 | March 27, 2027 | Drug substance, Drug product | None | 210951 |
| 8445507 | February 14, 2032 | Drug substance, Drug product | U-2624 | 210951 |
| 8445507 | February 14, 2032 | Drug substance, Drug product | U-2237 | 210951 |
| 9481663 | June 4, 2033 | Drug substance, Drug product | U-2624 | 210951 |
| 9481663 | June 4, 2033 | Drug substance, Drug product | U-2237 | 210951 |
| 9884054 | September 23, 2033 | Method of use | U-2237 | 210951 |
| RE50642 | September 23, 2033 | Method of use | U-4450 | 210951 |
| RE49353 | September 23, 2033 | Method of use | U-2381 | 210951 |
| 10849888 | September 23, 2033 | Method of use | U-3013 | 210951 |
| 12303493 | December 3, 2035 | Drug product | None | 210951 |
| 10702508 | April 30, 2038 | Method of use | U-3012 | 210951 |
| 12303497 | January 30, 2040 | Method of use | U-4448 | 210951 |
| 11963952 | January 30, 2040 | Method of use | U-3901 | 210951 |
| 12303497 | January 30, 2040 | Method of use | U-4494 | 210951 |
| 11723898 | January 14, 2041 | Method of use | U-4449 | 210951 |
Erleada NDC codes
Questions
Is there a generic for Erleada?
Yes. The generic name for Erleada is apalutamide. 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 2 Erleada products the Orange Book lists.
What is the generic name for Erleada?
The active ingredient in Erleada is apalutamide, per the FDA Orange Book.
When does the Erleada patent expire?
The last patent listed for Erleada in the Orange Book expires January 14, 2041. 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.