FDA Orange Book
Generic for Ravicti
Ravicti contains glycerol phenylbutyrate. 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 Ravicti is glycerol phenylbutyrate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
Run it in Rivvi
Map Ravicti and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ravicti products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| liquid, oral | 1.1GM/ML | Marketed (Rx) | AA | 7 | AA |
NDA 203284, held by HORIZON THERAPEUTICS US HOLDING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glycerol phenylbutyrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 205742 | AA (A-rated, therapeutically equivalent) | December 2, 2021 | 1.1GM/ML |
| AUROBINDO PHARMA LTD | 220313 | AA (A-rated, therapeutically equivalent) | April 15, 2026 | 1.1GM/ML |
| MSN LABORATORIES PRIVATE LTD | 219540 | AA (A-rated, therapeutically equivalent) | April 15, 2026 | 1.1GM/ML |
| TEVA PHARMACEUTICALS INC | 218738 | AA (A-rated, therapeutically equivalent) | April 15, 2026 | 1.1GM/ML |
| NAVINTA LLC | 220568 | AA (A-rated, therapeutically equivalent) | April 23, 2026 | 1.1GM/ML |
| LUPIN LTD | 207694 | AA (A-rated, therapeutically equivalent) | April 30, 2026 | 1.1GM/ML |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 220579 | AA (A-rated, therapeutically equivalent) | July 28, 2026 | 1.1GM/ML |
Ravicti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9962359 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 9561197 | September 22, 2030 | Method of use | U-1383 | 203284 |
| 10183003 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10183002 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10183004 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 8642012 | September 22, 2030 | Method of use | U-1383 | 203284 |
| 10045959 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 9999608 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 9326966 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10668040 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10183005 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10183006 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 10045958 | September 22, 2030 | Method of use | U-1816 | 203284 |
| 9254278 | September 22, 2030 | Method of use | U-1816 | 203284 |
Ravicti NDC codes
Questions
Is there a generic for Ravicti?
Yes. The generic name for Ravicti is glycerol phenylbutyrate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Ravicti?
The active ingredient in Ravicti is glycerol phenylbutyrate, per the FDA Orange Book.
When does the Ravicti patent expire?
The last patent listed for Ravicti in the Orange Book expires September 22, 2030. 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.