FDA Orange Book
Generic for Safyral
Safyral contains drospirenone, ethinyl estradiol and levomefolate. 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 Safyral is drospirenone, ethinyl estradiol and levomefolate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Safyral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | Marketed (Rx) | AB | 2 | AB |
NDA 022574, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic drospirenone, ethinyl estradiol and levomefolate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 203594 | AB (A-rated, therapeutically equivalent) | October 11, 2016 | 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG |
| LUPIN LTD | 205948 | AB (A-rated, therapeutically equivalent) | December 12, 2017 | 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG |
Safyral patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8617597 | February 8, 2030 | Drug product | None | 022574 |
| 11617751 | July 17, 2030 | Drug product | U-1 | 022574 |
| 11617751 | July 17, 2030 | Drug product | U-3572 | 022574 |
Questions
Is there a generic for Safyral?
Yes. The generic name for Safyral is drospirenone, ethinyl estradiol and levomefolate. 2 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 Safyral?
The active ingredient in Safyral is drospirenone, ethinyl estradiol and levomefolate, per the FDA Orange Book.
When does the Safyral patent expire?
The last patent listed for Safyral in the Orange Book expires July 17, 2030. 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.