FDA Orange Book
Generic for Duragesic-75
Duragesic-75 contains fentanyl. 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 Duragesic-75 is fentanyl. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Duragesic-75 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 75MCG/HR | Discontinued | None | 4 | AB |
NDA 019813, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fentanyl
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN TECHNOLOGIES INC | 076258 | AB (A-rated, therapeutically equivalent) | January 28, 2005 | 75MCG/HR |
| DIFGEN PHARMACEUTICALS LLC | 077449 | AB (A-rated, therapeutically equivalent) | October 20, 2008 | 75MCG/HR |
| SPECGX LLC | 077154 | AB (A-rated, therapeutically equivalent) | February 9, 2011 | 75MCG/HR |
| KINDEVA DRUG DELIVERY LP | 202097 | AB (A-rated, therapeutically equivalent) | November 4, 2016 | 75MCG/HR |
Questions
Is there a generic for Duragesic-75?
Yes. The generic name for Duragesic-75 is fentanyl. 4 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 Duragesic-75?
The active ingredient in Duragesic-75 is fentanyl, per the FDA Orange Book.
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.