FDA Orange Book
Generic for Lexiscan
Lexiscan contains regadenoson. 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 Lexiscan is regadenoson. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Lexiscan and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lexiscan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 0.4MG/5ML (0.08MG/ML) | Marketed (Rx) | AP | 11 | AP |
NDA 022161, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic regadenoson
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 213236 | AP (A-rated, therapeutically equivalent) | April 11, 2022 | 0.4MG/5ML (0.08MG/ML) |
| APOTEX INC | 207604 | AP (A-rated, therapeutically equivalent) | April 11, 2022 | 0.4MG/5ML (0.08MG/ML) |
| DR REDDYS LABORATORIES LTD | 213210 | AP (A-rated, therapeutically equivalent) | April 11, 2022 | 0.4MG/5ML (0.08MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 212806 | AP (A-rated, therapeutically equivalent) | April 11, 2022 | 0.4MG/5ML (0.08MG/ML) |
| INTERNATIONAL MEDICATION SYSTEMS LTD | 214252 | AP (A-rated, therapeutically equivalent) | May 23, 2022 | 0.4MG/5ML (0.08MG/ML) |
| GLAND PHARMA LTD | 207320 | AP (A-rated, therapeutically equivalent) | July 12, 2022 | 0.4MG/5ML (0.08MG/ML) |
| HOSPIRA INC | 214349 | AP (A-rated, therapeutically equivalent) | August 31, 2022 | 0.4MG/5ML (0.08MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 216437 | AP (A-rated, therapeutically equivalent) | October 26, 2022 | 0.4MG/5ML (0.08MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 215827 | AP (A-rated, therapeutically equivalent) | February 2, 2023 | 0.4MG/5ML (0.08MG/ML) |
| BAXTER HEALTHCARE CORP | 217455 | AP (A-rated, therapeutically equivalent) | May 23, 2023 | 0.4MG/5ML (0.08MG/ML) |
| INDIES PHARMA JAMAICA LTD | 218054 | AP (A-rated, therapeutically equivalent) | August 22, 2024 | 0.4MG/5ML (0.08MG/ML) |
Lexiscan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8106183 | February 2, 2027 | Drug substance | None | 022161 |
| RE47301 | February 2, 2027 | Drug product | None | 022161 |
Lexiscan NDC codes
Questions
Is there a generic for Lexiscan?
Yes. The generic name for Lexiscan is regadenoson. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Lexiscan?
The active ingredient in Lexiscan is regadenoson, per the FDA Orange Book.
When does the Lexiscan patent expire?
The last patent listed for Lexiscan in the Orange Book expires February 2, 2027. 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.