FDA Orange Book
Generic for Kuvan
Kuvan contains sapropterin. 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 Kuvan is sapropterin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Kuvan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 100MG/PACKET | Marketed (Rx) | AB | 6 | AB |
| for solution, oral | 500MG/PACKET | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 100MG | Marketed (Rx) | AB | 5 | AB |
NDA 205065, 022181, held by BIOMARIN PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sapropterin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 207200 | AB (A-rated, therapeutically equivalent) | May 10, 2019 | 100MG |
| PH HEALTH LTD | 207207 | AB (A-rated, therapeutically equivalent) | August 20, 2019 | 100MG/PACKET |
| PH HEALTH LTD | 210027 | AB (A-rated, therapeutically equivalent) | August 20, 2019 | 500MG/PACKET |
| DR REDDYS LABORATORIES LTD | 209452 | AB (A-rated, therapeutically equivalent) | March 30, 2021 | 100MG/PACKET |
| DR REDDYS LABORATORIES LTD | 207685 | AB (A-rated, therapeutically equivalent) | June 15, 2021 | 100MG |
| DR REDDYS LABORATORIES LTD | 215798 | AB (A-rated, therapeutically equivalent) | May 13, 2022 | 500MG/PACKET |
| ANNORA PHARMA PRIVATE LTD | 215420 | AB (A-rated, therapeutically equivalent) | August 18, 2022 | 100MG/PACKET, 500MG/PACKET |
| ANNORA PHARMA PRIVATE LTD | 215534 | AB (A-rated, therapeutically equivalent) | August 23, 2022 | 100MG |
| AUCTA PHARMACEUTICALS INC | 218645 | AB (A-rated, therapeutically equivalent) | April 29, 2025 | 100MG/PACKET, 500MG/PACKET |
| AUROBINDO PHARMA LTD | 216797 | AB (A-rated, therapeutically equivalent) | June 9, 2025 | 100MG |
| HIKMA PHARMACEUTICALS USA INC | 218797 | AB (A-rated, therapeutically equivalent) | June 11, 2025 | 100MG |
| HOPEWELL PHARMA VENTURES INC | 216432 | AB (A-rated, therapeutically equivalent) | September 3, 2025 | 100MG/PACKET, 500MG/PACKET |
| MICRO LABS LTD | 219511 | AB (A-rated, therapeutically equivalent) | January 8, 2026 | 100MG/PACKET, 500MG/PACKET |
Kuvan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7566462 | November 16, 2025 | Drug product | None | 022181 |
| 8003126 | November 16, 2025 | Method of use | None | 022181 |
| 7566462*PED | May 16, 2026 | Method of use | None | 022181 |
| 8003126*PED | May 16, 2026 | Method of use | None | 022181 |
| 9216178 | November 1, 2032 | Drug product | None | 205065 |
| 9216178*PED | May 1, 2033 | Method of use | None | 205065 |
Kuvan NDC codes
Questions
Is there a generic for Kuvan?
Yes. The generic name for Kuvan is sapropterin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Kuvan?
The active ingredient in Kuvan is sapropterin, per the FDA Orange Book.
When does the Kuvan patent expire?
The last patent listed for Kuvan in the Orange Book expires May 1, 2033. 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.