FDA Orange Book
Is there a generic for Orladeyo?
Orladeyo contains berotralstat. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orladeyo (berotralstat). The Orange Book shows its last listed patent expires May 1, 2040 and its last listed exclusivity ends June 11, 2029.
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Orladeyo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 110MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 108MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 132MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 72MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 96MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
NDA 214094, 219776, held by BIOCRYST PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orladeyo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11230530 | March 9, 2035 | Method of use | U-3300 | 214094 |
| 11708333 | March 9, 2035 | Method of use | U-3300 | 214094 |
| 10689346 | March 9, 2035 | Method of use | U-3010 | 214094 |
| 10329260 | March 9, 2035 | Drug substance | None | 214094 |
| 12116346 | March 9, 2035 | Drug substance | None | 214094 |
| 11708333 | March 9, 2035 | Method of use | U-4535 | 219776 |
| 11230530 | March 9, 2035 | Method of use | U-4535 | 219776 |
| 10689346 | March 9, 2035 | Method of use | U-4535 | 219776 |
| 10125102 | April 7, 2035 | Drug substance | U-3010 | 214094 |
| 10125102 | April 7, 2035 | Drug substance | U-4535 | 219776 |
| 12116346*PED | September 9, 2035 | Method of use | None | 214094 |
| 11708333*PED | September 9, 2035 | Method of use | None | 214094 |
| 11230530*PED | September 9, 2035 | Method of use | None | 214094 |
| 10689346*PED | September 9, 2035 | Method of use | None | 214094 |
| 10329260*PED | September 9, 2035 | Method of use | None | 214094 |
| 10125102*PED | October 7, 2035 | Method of use | None | 214094 |
| 11117867 | November 1, 2039 | Drug product | U-3010 | 214094 |
| 12344585 | November 1, 2039 | Method of use | U-3010 | 214094 |
| 10662160 | November 1, 2039 | Drug substance | U-3010 | 214094 |
| 11618733 | November 1, 2039 | Method of use | U-3300 | 214094 |
| 12552750 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12590068 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12545647 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12545645 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12590069 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12545646 | November 1, 2039 | Drug substance, Drug product | None | 214094 |
| 12344585 | November 1, 2039 | Method of use | U-4535 | 219776 |
| 11618733 | November 1, 2039 | Method of use | U-4535 | 219776 |
| 11117867 | November 1, 2039 | Drug product | U-4535 | 219776 |
| 10662160 | November 1, 2039 | Drug substance | U-4535 | 219776 |
| 12344585*PED | May 1, 2040 | Method of use | None | 214094 |
| 11618733*PED | May 1, 2040 | Method of use | None | 214094 |
| 12590069*PED | May 1, 2040 | Method of use | None | 214094 |
| 12590068*PED | May 1, 2040 | Method of use | None | 214094 |
| 11117867*PED | May 1, 2040 | Method of use | None | 214094 |
| 12552750*PED | May 1, 2040 | Method of use | None | 214094 |
| 12545647*PED | May 1, 2040 | Method of use | None | 214094 |
| 12545646*PED | May 1, 2040 | Method of use | None | 214094 |
| 12545645*PED | May 1, 2040 | Method of use | None | 214094 |
| 10662160*PED | May 1, 2040 | Method of use | None | 214094 |
Orladeyo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-333 | Orphan drug exclusivity | December 3, 2027 | 214094 |
| PED | Pediatric exclusivity | June 3, 2028 | 214094 |
| NP | New product | December 11, 2028 | 219776 |
| PED | Pediatric exclusivity | June 11, 2029 | 219776 |
Orladeyo NDC codes
Questions
Is there a generic for Orladeyo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orladeyo (berotralstat). The Orange Book shows its last listed patent expires May 1, 2040 and its last listed exclusivity ends June 11, 2029.
What is the generic name for Orladeyo?
The active ingredient in Orladeyo is berotralstat, per the FDA Orange Book.
When does the Orladeyo patent expire?
The last patent listed for Orladeyo in the Orange Book expires May 1, 2040. 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.