FDA Orange Book
Is there a generic for Rasuvo?
Rasuvo contains methotrexate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rasuvo (methotrexate). The Orange Book shows its last listed patent expires June 1, 2029.
Run it in Rivvi
Map Rasuvo 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.
Rasuvo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 10MG/0.20ML (10MG/0.20ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 12.5MG/0.25ML (12.5MG/0.25ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 15MG/0.30ML (15MG/0.30ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 17.5MG/0.35ML (17.5MG/0.35ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 20MG/0.4ML (20MG/0.4ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 22.5MG/0.45ML (22.5MG/0.45ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 25MG/0.5ML (25MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 27.5MG/0.55ML (27.5MG/0.55ML) | Discontinued | None | 0 | None |
| solution, subcutaneous | 30MG/0.6ML (30MG/0.6ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 7.5MG/0.15ML (7.5MG/0.15ML) | Marketed (Rx) | None | 0 | None |
NDA 205776, held by MEDEXUS PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rasuvo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8664231 | June 1, 2029 | Method of use | U-1442 | 205776 |
Rasuvo NDC codes
Questions
Is there a generic for Rasuvo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rasuvo (methotrexate). The Orange Book shows its last listed patent expires June 1, 2029.
What is the generic name for Rasuvo?
The active ingredient in Rasuvo is methotrexate, per the FDA Orange Book.
When does the Rasuvo patent expire?
The last patent listed for Rasuvo in the Orange Book expires June 1, 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 Rasuvo and Methotrexate
- What is Rasuvo used for?FDA label uses
- Is Rasuvo a controlled substance?Federal schedule
- What is Methotrexate used for?FDA label uses
- Is Methotrexate a controlled substance?Federal schedule
- Generic for JylamvoFDA Orange Book
- Generic for XatmepFDA Orange Book
- Folate Analog Metabolic Inhibitors listFDA drug class
- NDC 59137-505Rasuvo NDC record
- NDC 59137-510Rasuvo NDC record
- NDC 59137-515Rasuvo NDC record