FDA Orange Book
Is there a generic for Procysbi?
Procysbi contains cysteamine. 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 Procysbi (cysteamine). The Orange Book shows its last listed patent expires February 16, 2037.
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Procysbi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, delayed release, oral | EQ 75MG BASE | Marketed (Rx) | None | 0 | None |
| granule, delayed release, oral | EQ 300MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| granule, delayed release, oral | EQ 75MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
NDA 203389, 213491, held by HORIZON THERAPEUTICS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Procysbi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9198882 | January 26, 2027 | Method of use | U-1399 | 203389 |
| 9192590 | January 26, 2027 | Method of use | U-1399 | 203389 |
| 9925158 | January 26, 2027 | Drug substance, Drug product | U-1399 | 203389 |
| 9925157 | January 26, 2027 | Drug substance, Drug product | U-1399 | 203389 |
| 9925156 | January 26, 2027 | Drug substance, Drug product | U-1399 | 203389 |
| 9198882*PED | July 26, 2027 | Method of use | None | 203389 |
| 9192590*PED | July 26, 2027 | Method of use | None | 203389 |
| 9925156*PED | July 26, 2027 | Method of use | None | 203389 |
| 9925157*PED | July 26, 2027 | Method of use | None | 203389 |
| 9925158*PED | July 26, 2027 | Method of use | None | 203389 |
| 8026284 | September 22, 2027 | Method of use | U-1399 | 203389 |
| 8026284*PED | March 22, 2028 | Method of use | None | 203389 |
| 9173851 | June 17, 2034 | Drug product | None | 203389 |
| 9233077 | June 17, 2034 | Drug product | None | 203389 |
| 9233077*PED | December 17, 2034 | Method of use | None | 203389 |
| 9173851*PED | December 17, 2034 | Method of use | None | 203389 |
| 10328037 | August 16, 2036 | Method of use | U-1399 | 203389 |
| 10548859 | August 16, 2036 | Method of use | U-1399 | 203389 |
| 10143665 | August 16, 2036 | Method of use | U-1399 | 203389 |
| 10905662 | August 16, 2036 | Method of use | U-1399 | 203389 |
| 10143665*PED | February 16, 2037 | Method of use | None | 203389 |
| 10548859*PED | February 16, 2037 | Method of use | None | 203389 |
| 10328037*PED | February 16, 2037 | Method of use | None | 203389 |
| 10905662*PED | February 16, 2037 | Method of use | None | 203389 |
Procysbi NDC codes
Questions
Is there a generic for Procysbi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Procysbi (cysteamine). The Orange Book shows its last listed patent expires February 16, 2037.
What is the generic name for Procysbi?
The active ingredient in Procysbi is cysteamine, per the FDA Orange Book.
When does the Procysbi patent expire?
The last patent listed for Procysbi in the Orange Book expires February 16, 2037. 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.