FDA Orange Book
Generic for Vyvanse
Vyvanse contains lisdexamfetamine. 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 Vyvanse is lisdexamfetamine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vyvanse products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | AB | 15 | AB |
| capsule, oral | 20MG | Marketed (Rx) | AB | 16 | AB |
| capsule, oral | 30MG | Marketed (Rx) | AB | 16 | AB |
| capsule, oral | 40MG | Marketed (Rx) | AB | 16 | AB |
| capsule, oral | 50MG | Marketed (Rx) | AB | 16 | AB |
| capsule, oral | 60MG | Marketed (Rx) | AB | 16 | AB |
| capsule, oral | 70MG | Marketed (Rx) | AB | 16 | AB |
| tablet, chewable, oral | 10MG | Marketed (Rx) | AB | 6 | AB |
| tablet, chewable, oral | 20MG | Marketed (Rx) | AB | 6 | AB |
| tablet, chewable, oral | 30MG | Marketed (Rx) | AB | 6 | AB |
| tablet, chewable, oral | 40MG | Marketed (Rx) | AB | 6 | AB |
| tablet, chewable, oral | 50MG | Marketed (Rx) | AB | 6 | AB |
| tablet, chewable, oral | 60MG | Marketed (Rx) | AB | 6 | AB |
NDA 021977, 208510, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lisdexamfetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 202802 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| ALKEM LABORATORIES LTD | 217194 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| APOTEX INC | 216944 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| ASCENT PHARMACEUTICALS INC | 217442 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| LANNETT CO INC | 215802 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| MYLAN PHARMACEUTICALS INC | 202835 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| NORWICH PHARMACEUTICALS INC | 214547 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| PRINSTON PHARMACEUTICAL INC | 216266 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| RHODES PHARMACEUTICALS LP | 215330 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| SPECGX LLC | 211840 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 214484 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| AMNEAL PHARMACEUTICALS LLC | 202830 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| ASCENT PHARMACEUTICALS INC | 217068 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 214134 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| TEVA PHARMACEUTICALS DEVELOPMENT INC | 215415 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| HIKMA PHARMACEUTICALS USA INC | 202827 | AB (A-rated, therapeutically equivalent) | January 17, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| MSN LABORATORIES PRIVATE LTD | 218306 | AB (A-rated, therapeutically equivalent) | February 2, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| ELITE LABORATORIES INC | 218604 | AB (A-rated, therapeutically equivalent) | November 15, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| GRANULES PHARMACEUTICALS INC | 219258 | AB (A-rated, therapeutically equivalent) | December 16, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| SPECGX LLC | 218850 | AB (A-rated, therapeutically equivalent) | December 17, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| SANDOZ INC | 202836 | AB (A-rated, therapeutically equivalent) | December 26, 2024 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
| GRANULES PHARMACEUTICALS INC | 218987 | AB (A-rated, therapeutically equivalent) | January 29, 2025 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG, 70MG |
Vyvanse NDC codes
Questions
Is there a generic for Vyvanse?
Yes. The generic name for Vyvanse is lisdexamfetamine. 18 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 Vyvanse?
The active ingredient in Vyvanse is lisdexamfetamine, 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.
More on Vyvanse and Lisdexamfetamine
- What is Vyvanse used for?FDA label uses
- Is Vyvanse a controlled substance?Schedule II
- What is Lisdexamfetamine used for?FDA label uses
- Is Lisdexamfetamine a controlled substance?Schedule II
- Generic for AryntaFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 59417-101Vyvanse NDC record
- NDC 59417-102Vyvanse NDC record
- NDC 59417-103Vyvanse NDC record
- Schedule II drugs listDEA schedule