FDA Orange Book · active-ingredient family
Drospirenone; ethinyl estradiol; levomefolate calcium
Drospirenone; ethinyl estradiol; levomefolate calcium is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SAFYRAL · NDA 022574
2
Brand (NDA)
4
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAFYRALRLD | BAYER HLTHCARE | NDA 022574 | AB | Dec 16, 2010 | |
| BEYAZRLD | BAYER HLTHCARE | NDA 022532 | AB | Sep 24, 2010 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | LUPIN | ANDA 205947 | AB | Jun 13, 2018 | |
| TYDEMY | LUPIN | ANDA 205948 | AB | Dec 12, 2017 | |
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | WATSON LABS INC | ANDA 203593 | AB | Oct 11, 2016 | |
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | WATSON LABS INC | ANDA 203594 | AB | Oct 11, 2016 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8617597 | Feb 08, 2030 | in 3 yr 8 mo | Product |
| 11617751 | Jul 17, 2030 | in 4 yr 2 mo | ProductU-1 |
Drospirenone; ethinyl estradiol; levomefolate calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
