FDA Orange Book
Is there a generic for Pemazyre?
Pemazyre contains pemigatinib. 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 Pemazyre (pemigatinib). The Orange Book shows its last listed patent expires October 3, 2040 and its last listed exclusivity ends August 26, 2029.
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Pemazyre products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 13.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 4.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 213736, held by INCYTE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pemazyre patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10131667 | April 17, 2034 | Method of use | U-2809 | 213736 |
| 9611267 | January 30, 2035 | Drug substance, Drug product | None | 213736 |
| 11466004 | May 3, 2039 | Method of use | U-3464 | 213736 |
| 11466004 | May 3, 2039 | Method of use | U-3465 | 213736 |
| 11466004 | May 3, 2039 | Method of use | U-3466 | 213736 |
| 11628162 | August 30, 2040 | Method of use | U-3568 | 213736 |
| 11628162 | August 30, 2040 | Method of use | U-3569 | 213736 |
| 11628162 | August 30, 2040 | Method of use | U-3570 | 213736 |
| 11628162 | August 30, 2040 | Method of use | U-3571 | 213736 |
| 12552792 | October 3, 2040 | Drug substance, Drug product | None | 213736 |
Pemazyre exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-292 | Orphan drug exclusivity | April 17, 2027 | 213736 |
| ODE-404 | Orphan drug exclusivity | August 26, 2029 | 213736 |
Pemazyre NDC codes
Questions
Is there a generic for Pemazyre?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pemazyre (pemigatinib). The Orange Book shows its last listed patent expires October 3, 2040 and its last listed exclusivity ends August 26, 2029.
What is the generic name for Pemazyre?
The active ingredient in Pemazyre is pemigatinib, per the FDA Orange Book.
When does the Pemazyre patent expire?
The last patent listed for Pemazyre in the Orange Book expires October 3, 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.