FDA Orange Book
Generic for Mydayis
Mydayis contains dextroamphetamine and amphetamine. 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 Mydayis is dextroamphetamine and amphetamine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Mydayis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 12.5MG;12.5MG;12.5MG;12.5MG | Marketed (Rx) | AB2 | 3 | AB2 |
| capsule, extended release, oral | 3.125MG;3.125MG;3.125MG;3.125MG | Marketed (Rx) | AB2 | 3 | AB2 |
| capsule, extended release, oral | 6.25MG;6.25MG;6.25MG;6.25MG | Marketed (Rx) | AB2 | 13 | AB1, AB2 |
| capsule, extended release, oral | 9.375MG;9.375MG;9.375MG;9.375MG | Marketed (Rx) | AB2 | 3 | AB2 |
NDA 022063, 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 dextroamphetamine and amphetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 077302 | AB1 (A-rated, therapeutically equivalent) | June 22, 2012 | 6.25MG;6.25MG;6.25MG;6.25MG |
| IMPAX LABORATORIES INC | 076852 | AB1 (A-rated, therapeutically equivalent) | February 16, 2016 | 6.25MG;6.25MG;6.25MG;6.25MG |
| ANI PHARMACEUTICALS INC | 205401 | AB1 (A-rated, therapeutically equivalent) | January 22, 2019 | 6.25MG;6.25MG;6.25MG;6.25MG |
| SPECGX LLC | 211547 | AB1 (A-rated, therapeutically equivalent) | April 22, 2019 | 6.25MG;6.25MG;6.25MG;6.25MG |
| RHODES PHARMACEUTICALS LP | 210651 | AB1 (A-rated, therapeutically equivalent) | May 17, 2019 | 6.25MG;6.25MG;6.25MG;6.25MG |
| ELITE LABORATORIES INC | 212037 | AB1 (A-rated, therapeutically equivalent) | December 11, 2019 | 6.25MG;6.25MG;6.25MG;6.25MG |
| ASCENT PHARMACEUTICALS INC | 214959 | AB1 (A-rated, therapeutically equivalent) | September 29, 2021 | 6.25MG;6.25MG;6.25MG;6.25MG |
| LANNETT CO INC | 214403 | AB1 (A-rated, therapeutically equivalent) | November 26, 2021 | 6.25MG;6.25MG;6.25MG;6.25MG |
| TEVA PHARMACEUTICALS USA INC | 210876 | AB2 (A-rated, therapeutically equivalent) | January 31, 2022 | 12.5MG;12.5MG;12.5MG;12.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 6.25MG;6.25MG;6.25MG;6.25MG, 9.375MG;9.375MG;9.375MG;9.375MG |
| GRANULES PHARMACEUTICALS INC | 217027 | AB1 (A-rated, therapeutically equivalent) | January 23, 2023 | 6.25MG;6.25MG;6.25MG;6.25MG |
| SPECGX LLC | 211546 | AB2 (A-rated, therapeutically equivalent) | August 31, 2023 | 12.5MG;12.5MG;12.5MG;12.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 6.25MG;6.25MG;6.25MG;6.25MG, 9.375MG;9.375MG;9.375MG;9.375MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 215997 | AB2 (A-rated, therapeutically equivalent) | September 27, 2023 | 12.5MG;12.5MG;12.5MG;12.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 6.25MG;6.25MG;6.25MG;6.25MG, 9.375MG;9.375MG;9.375MG;9.375MG |
| LUPIN INC | 214777 | AB1 (A-rated, therapeutically equivalent) | November 7, 2024 | 6.25MG;6.25MG;6.25MG;6.25MG |
Mydayis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9173857 | May 12, 2026 | Method of use | U-2025 | 022063 |
| 8846100 | August 24, 2029 | Drug product | None | 022063 |
Mydayis NDC codes
Questions
Is there a generic for Mydayis?
Yes. The generic name for Mydayis is dextroamphetamine and amphetamine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Mydayis?
The active ingredient in Mydayis is dextroamphetamine and amphetamine, per the FDA Orange Book.
When does the Mydayis patent expire?
The last patent listed for Mydayis in the Orange Book expires August 24, 2029. 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 Mydayis and Dextroamphetamine and Amphetamine
- What is Mydayis used for?FDA label uses
- Is Mydayis a controlled substance?Schedule II
- What is Dextroamphetamine and Amphetamine used for?FDA label uses
- Is Dextroamphetamine and Amphetamine a controlled substance?Schedule II
- Generic for Adderall XRFDA Orange Book
- Generic for AdderallFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 54092-468Mydayis NDC record
- NDC 54092-471Mydayis NDC record
- NDC 54092-474Mydayis NDC record
- Schedule II drugs listDEA schedule