FDA Orange Book
Generic for Phyrago
Phyrago contains dasatinib. 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 Phyrago is dasatinib. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Phyrago products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 9 | AB |
| tablet, oral | 140MG | Marketed (Rx) | None | 9 | AB |
| tablet, oral | 20MG | Marketed (Rx) | None | 9 | AB |
| tablet, oral | 50MG | Marketed (Rx) | None | 9 | AB |
| tablet, oral | 70MG | Marketed (Rx) | None | 9 | AB |
| tablet, oral | 80MG | Marketed (Rx) | None | 9 | AB |
NDA 216099, held by HANDA THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dasatinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 202103 | AB (A-rated, therapeutically equivalent) | June 10, 2016 | 100MG, 20MG, 50MG, 70MG |
| APOTEX INC | 203180 | AB (A-rated, therapeutically equivalent) | November 23, 2021 | 140MG, 80MG |
| BIOCON PHARMA LTD | 217217 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| DR REDDYS LABORATORIES LTD | 213383 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 218719 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| EUGIA PHARMA SPECIALITIES LTD | 216547 | AB (A-rated, therapeutically equivalent) | April 22, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| LUPIN INC | 214350 | AB (A-rated, therapeutically equivalent) | August 25, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| TEVA PHARMACEUTICALS USA INC | 211094 | AB (A-rated, therapeutically equivalent) | August 27, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| ALEMBIC PHARMACEUTICALS LTD | 216261 | AB (A-rated, therapeutically equivalent) | November 6, 2025 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
| MSN LABORATORIES PRIVATE LTD | 219579 | AB (A-rated, therapeutically equivalent) | September 11, 2026 | 100MG, 140MG, 20MG, 50MG, 70MG, 80MG |
Phyrago patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12544376 | January 22, 2041 | Method of use | U-3767 | 216099 |
| 12544376 | January 22, 2041 | Method of use | U-3768 | 216099 |
| 12544376 | January 22, 2041 | Method of use | U-3769 | 216099 |
| 12544376 | January 22, 2041 | Method of use | U-3770 | 216099 |
| 12544376 | January 22, 2041 | Method of use | U-3771 | 216099 |
| 12544376 | January 22, 2041 | Method of use | U-3772 | 216099 |
| 11324745 | January 22, 2041 | Method of use | U-3767 | 216099 |
| 11324745 | January 22, 2041 | Method of use | U-3768 | 216099 |
| 11324745 | January 22, 2041 | Method of use | U-3769 | 216099 |
| 11202778 | January 22, 2041 | Method of use | U-3770 | 216099 |
| 11202778 | January 22, 2041 | Method of use | U-3771 | 216099 |
| 11202778 | January 22, 2041 | Method of use | U-3772 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3769 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3768 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3767 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3770 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3771 | 216099 |
| 12433891 | January 22, 2041 | Method of use | U-3772 | 216099 |
| 12465606 | January 22, 2041 | Drug product | None | 216099 |
| 11298356 | January 22, 2041 | Drug product | None | 216099 |
Phyrago exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-307 | Miscellaneous | December 5, 2026 | 216099 |
Phyrago NDC codes
Questions
Is there a generic for Phyrago?
Yes. The generic name for Phyrago is dasatinib. 9 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 Phyrago?
The active ingredient in Phyrago is dasatinib, per the FDA Orange Book.
When does the Phyrago patent expire?
The last patent listed for Phyrago in the Orange Book expires January 22, 2041. 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.