FDA Orange Book
Generic for Pennsaid
Pennsaid contains diclofenac. 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 Pennsaid is diclofenac. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Pennsaid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, topical | 1.5% | Discontinued | None | 7 | AT |
| solution, topical | 2% | Discontinued | None | 7 | AB |
NDA 020947, 204623, held by HORIZON THERAPEUTICS IRELAND DAC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diclofenac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 202852 | AT (A-rated, therapeutically equivalent) | November 24, 2014 | 1.5% |
| SUN PHARMA CANADA INC | 203818 | AT (A-rated, therapeutically equivalent) | November 26, 2014 | 1.5% |
| LUPIN LTD | 204132 | AT (A-rated, therapeutically equivalent) | August 20, 2015 | 1.5% |
| NOVEL LABORATORIES INC | 205878 | AT (A-rated, therapeutically equivalent) | December 9, 2015 | 1.5% |
| AMNEAL PHARMACEUTICALS | 206116 | AT (A-rated, therapeutically equivalent) | September 2, 2016 | 1.5% |
| ZYDUS LIFESCIENCES LTD | 206411 | AT (A-rated, therapeutically equivalent) | April 17, 2018 | 1.5% |
| EPIC PHARMA LLC | 206655 | AT (A-rated, therapeutically equivalent) | January 28, 2021 | 1.5% |
| APOTEX INC | 207714 | AB (A-rated, therapeutically equivalent) | May 6, 2022 | 2% |
| AMNEAL PHARMACEUTICALS LLC | 208198 | AB (A-rated, therapeutically equivalent) | August 18, 2022 | 2% |
| LUPIN PHARMACEUTICALS INC | 208021 | AB (A-rated, therapeutically equivalent) | September 20, 2022 | 2% |
| SUN PHARMA CANADA INC | 208098 | AB (A-rated, therapeutically equivalent) | September 29, 2022 | 2% |
| ALEMBIC PHARMACEUTICALS LTD | 212506 | AB (A-rated, therapeutically equivalent) | November 29, 2022 | 2% |
| AUROLIFE PHARMA LLC | 213040 | AB (A-rated, therapeutically equivalent) | February 3, 2023 | 2% |
| ENCUBE ETHICALS PRIVATE LTD | 217646 | AB (A-rated, therapeutically equivalent) | April 9, 2025 | 2% |
Pennsaid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9132110 | October 17, 2027 | Method of use | U-1488 | 204623 |
| 9168305 | October 17, 2027 | Method of use | U-1488 | 204623 |
| 9066913 | October 17, 2027 | Drug product | U-1488 | 204623 |
| 9339551 | October 17, 2027 | Method of use | U-1488 | 204623 |
| 9220784 | October 17, 2027 | Method of use | U-1488 | 204623 |
| 9339552 | October 17, 2027 | Drug product | U-1488 | 204623 |
| 9539335 | October 17, 2027 | Method of use | U-1614 | 204623 |
| 8563613 | October 17, 2027 | Drug product | U-1488 | 204623 |
| 8871809 | October 17, 2027 | Method of use | U-1614 | 204623 |
| 9101591 | October 17, 2027 | Drug product | U-1488 | 204623 |
| 9168304 | October 17, 2027 | Drug product | None | 204623 |
| 8252838 | April 21, 2028 | Drug product | U-1489 | 204623 |
| 8741956 | July 10, 2029 | Method of use | U-1435 | 204623 |
| 8618164 | July 10, 2029 | Method of use | U-1477 | 204623 |
| 9370501 | July 10, 2029 | Method of use | U-1614 | 204623 |
| 8217078 | July 10, 2029 | Method of use | U-1477 | 204623 |
| 9375412 | July 10, 2029 | Method of use | U-1614 | 204623 |
| 9415029 | July 10, 2029 | Method of use | U-1614 | 204623 |
| 8217078 | July 10, 2029 | Method of use | U-1248 | 020947 |
| 8546450 | August 9, 2030 | Method of use | U-1435 | 204623 |
| 8546450 | August 9, 2030 | Method of use | U-1436 | 204623 |
Questions
Is there a generic for Pennsaid?
Yes. The generic name for Pennsaid is diclofenac. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Pennsaid?
The active ingredient in Pennsaid is diclofenac, per the FDA Orange Book.
When does the Pennsaid patent expire?
The last patent listed for Pennsaid in the Orange Book expires August 9, 2030. 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.