FDA Orange Book
Generic for Aricept
Aricept contains donepezil. 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 Aricept is donepezil. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Aricept products the Orange Book lists.
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Aricept products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Marketed (Rx) | AB | 15 | AB |
| tablet, oral | 23MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 15 | AB |
NDA 021719, 020690, 022568, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic donepezil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 090056 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 090425 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| CIPLA LTD | 077518 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| DR REDDYS LABORATORIES LTD | 201001 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| JUBILANT GENERICS LTD | 090768 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| NOVITIUM PHARMA LLC | 090551 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 200292 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 090686 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 10MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 201146 | AB (A-rated, therapeutically equivalent) | August 17, 2012 | 10MG, 5MG |
| ZYDUS LIFESCIENCES LTD | 090100 | AB (A-rated, therapeutically equivalent) | October 24, 2012 | 10MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 201724 | AB (A-rated, therapeutically equivalent) | February 25, 2013 | 10MG, 5MG |
| RISING PHARMA HOLDING INC | 202114 | AB (A-rated, therapeutically equivalent) | July 5, 2013 | 10MG, 5MG |
| DR REDDYS LABORATORIES LTD | 202723 | AB (A-rated, therapeutically equivalent) | July 24, 2013 | 23MG |
| MACLEODS PHARMACEUTICALS LTD | 202631 | AB (A-rated, therapeutically equivalent) | January 22, 2014 | 23MG |
| SCIEGEN PHARMACEUTICALS INC | 203907 | AB (A-rated, therapeutically equivalent) | October 29, 2014 | 10MG, 5MG |
| TWI PHARMACEUTICALS INC | 203104 | AB (A-rated, therapeutically equivalent) | October 29, 2014 | 23MG |
| HETERO LABS LTD UNIT V | 203034 | AB (A-rated, therapeutically equivalent) | January 30, 2015 | 10MG, 5MG |
| DEXCEL PHARMA TECHNOLOGIES LTD | 203713 | AB (A-rated, therapeutically equivalent) | February 19, 2016 | 23MG |
| ZYDUS PHARMACEUTICALS USA INC | 203162 | AB (A-rated, therapeutically equivalent) | August 31, 2017 | 23MG |
| CADILA PHARMACEUTICALS LTD | 204609 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 10MG, 5MG |
Aricept patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8481565 | October 4, 2026 | Drug product | None | 022568 |
Aricept NDC codes
Questions
Is there a generic for Aricept?
Yes. The generic name for Aricept is donepezil. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Aricept products the Orange Book lists.
What is the generic name for Aricept?
The active ingredient in Aricept is donepezil, per the FDA Orange Book.
When does the Aricept patent expire?
The last patent listed for Aricept in the Orange Book expires October 4, 2026. 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.