FDA Orange Book
Generic for Dificid
Dificid contains fidaxomicin. 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 Dificid is fidaxomicin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Dificid products the Orange Book lists.
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Dificid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 40MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | AB | 5 | AB |
NDA 213138, 201699, held by CUBIST PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fidaxomicin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 208443 | AB (A-rated, therapeutically equivalent) | January 16, 2024 | 200MG |
| TORRENT PHARMACEUTICALS LTD | 220374 | AB (A-rated, therapeutically equivalent) | January 27, 2026 | 200MG |
| APOTEX INC | 219559 | AB (A-rated, therapeutically equivalent) | February 2, 2026 | 200MG |
| SANDOZ INC | 220465 | AB (A-rated, therapeutically equivalent) | August 13, 2026 | 200MG |
| HIKMA PHARMACEUTICALS USA INC | 219737 | AB (A-rated, therapeutically equivalent) | October 7, 2026 | 200MG |
Dificid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7906489 | March 4, 2027 | Method of use | U-2741 | 213138 |
| 7906489 | March 4, 2027 | Method of use | U-319 | 201699 |
| 8859510 | July 31, 2027 | Method of use | U-2741 | 213138 |
| 7378508 | July 31, 2027 | Drug substance, Drug product | None | 213138 |
| 7863249 | July 31, 2027 | Drug product | None | 213138 |
| 8859510 | July 31, 2027 | Method of use | U-319 | 201699 |
| 7906489*PED | September 4, 2027 | Method of use | None | 213138 |
| 7378508*PED | January 31, 2028 | Method of use | None | 213138 |
| 7863249*PED | January 31, 2028 | Method of use | None | 213138 |
| 8859510*PED | January 31, 2028 | Method of use | None | 213138 |
| 9808530 | May 28, 2034 | Drug product | None | 213138 |
| 9808530*PED | November 28, 2034 | Method of use | None | 213138 |
Dificid exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-367 | Orphan drug exclusivity | January 24, 2027 | 213138 |
Dificid NDC codes
Questions
Is there a generic for Dificid?
Yes. The generic name for Dificid is fidaxomicin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Dificid products the Orange Book lists.
What is the generic name for Dificid?
The active ingredient in Dificid is fidaxomicin, per the FDA Orange Book.
When does the Dificid patent expire?
The last patent listed for Dificid in the Orange Book expires November 28, 2034. 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.