FDA Orange Book
Generic for Latuda
Latuda contains lurasidone. 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 Latuda is lurasidone. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Latuda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Marketed (Rx) | AB | 14 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 16 | AB |
| tablet, oral | 40MG | Marketed (Rx) | AB | 16 | AB |
| tablet, oral | 60MG | Marketed (Rx) | AB | 16 | AB |
| tablet, oral | 80MG | Marketed (Rx) | AB | 16 | AB |
NDA 200603, held by SUNOVION PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lurasidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 208049 | AB (A-rated, therapeutically equivalent) | January 3, 2019 | 120MG, 20MG, 40MG, 60MG, 80MG |
| INVAGEN PHARMACEUTICALS INC | 208028 | AB (A-rated, therapeutically equivalent) | January 3, 2019 | 120MG, 20MG, 40MG, 60MG, 80MG |
| LUPIN LTD | 208031 | AB (A-rated, therapeutically equivalent) | January 3, 2019 | 120MG, 20MG, 40MG, 60MG, 80MG |
| TORRENT PHARMACEUTICALS LTD | 208055 | AB (A-rated, therapeutically equivalent) | January 3, 2019 | 120MG, 20MG, 40MG, 60MG, 80MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 208066 | AB (A-rated, therapeutically equivalent) | January 4, 2019 | 20MG, 40MG, 60MG, 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 208052 | AB (A-rated, therapeutically equivalent) | March 19, 2019 | 120MG, 20MG, 40MG, 60MG, 80MG |
| CHARTWELL RX SCIENCES LLC | 212091 | AB (A-rated, therapeutically equivalent) | December 28, 2020 | 120MG, 20MG, 40MG, 60MG, 80MG |
| ALEMBIC PHARMACEUTICALS LTD | 213248 | AB (A-rated, therapeutically equivalent) | May 13, 2021 | 120MG, 20MG, 40MG, 60MG, 80MG |
| DR REDDYS LABORATORIES LTD | 208047 | AB (A-rated, therapeutically equivalent) | August 24, 2021 | 20MG, 40MG, 60MG, 80MG |
| MSN LABORATORIES PRIVATE LTD | 208037 | AB (A-rated, therapeutically equivalent) | September 9, 2022 | 120MG, 20MG, 40MG, 60MG, 80MG |
| ALKEM LABORATORIES LTD | 212244 | AB (A-rated, therapeutically equivalent) | December 13, 2022 | 120MG, 20MG, 40MG, 60MG, 80MG |
| HERITAGE PHARMA LABS INC DBA AVET PHARMACEUTICALS LABS INC | 208058 | AB (A-rated, therapeutically equivalent) | February 28, 2023 | 120MG, 20MG, 40MG, 60MG, 80MG |
| AUROBINDO PHARMA LTD | 208045 | AB (A-rated, therapeutically equivalent) | March 10, 2023 | 120MG, 20MG, 40MG, 60MG, 80MG |
| MACLEODS PHARMACEUTICALS LTD | 212124 | AB (A-rated, therapeutically equivalent) | June 9, 2023 | 120MG, 20MG, 40MG, 60MG, 80MG |
| ANNORA PHARMA PRIVATE LTD | 218174 | AB (A-rated, therapeutically equivalent) | August 21, 2024 | 120MG, 20MG, 40MG, 60MG, 80MG |
| JUBILANT GENERICS LTD | 210388 | AB (A-rated, therapeutically equivalent) | December 6, 2024 | 120MG, 20MG, 40MG, 60MG, 80MG |
Latuda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9555027 | May 26, 2026 | Drug product | U-543 | 200603 |
| 8883794 | May 26, 2026 | Drug product | None | 200603 |
| 8729085 | May 26, 2026 | Drug product | None | 200603 |
| 9907794 | May 26, 2026 | Drug product | None | 200603 |
| 8883794*PED | November 26, 2026 | Method of use | None | 200603 |
| 8729085*PED | November 26, 2026 | Method of use | None | 200603 |
| 9907794*PED | November 26, 2026 | Method of use | None | 200603 |
| 9259423 | May 23, 2031 | Method of use | U-1822 | 200603 |
| 9827242 | May 23, 2031 | Method of use | U-2199 | 200603 |
| 9827242 | May 23, 2031 | Method of use | U-2201 | 200603 |
| 9259423*PED | November 23, 2031 | Method of use | None | 200603 |
Latuda NDC codes
Questions
Is there a generic for Latuda?
Yes. The generic name for Latuda is lurasidone. 16 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 Latuda?
The active ingredient in Latuda is lurasidone, per the FDA Orange Book.
When does the Latuda patent expire?
The last patent listed for Latuda in the Orange Book expires November 23, 2031. 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.
More on Latuda and Lurasidone
- What is Latuda used for?FDA label uses
- Is Latuda a controlled substance?Federal schedule
- What is Lurasidone used for?FDA label uses
- Is Lurasidone a controlled substance?Federal schedule
- Atypical Antipsychotics listFDA drug class
- NDC 63402-302Latuda NDC record
- NDC 63402-304Latuda NDC record
- NDC 63402-306Latuda NDC record