FDA Orange Book · active-ingredient family
Drospirenone
Drospirenone: 2 brands, 0 generics; first approved May 23, 2019; on patent until Jun 28, 2031.
On patentHas discontinued products
Generic status & protection
Protected until Jun 28, 2031 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
16
Next patent expiry
Jun 28, 2031
in 4 yr 11 mo
Brand (NDA) products
Originator applications
- DROSPIRENONERLDEXELTIS USA INCNDA 2162852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG TABLET, CHEWABLE ORAL Discontinued — - EXELTIS USA INCNDA 2113672019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10603281 | in 4 yr 11 mo | U-2553 | |
| 10849857 | in 4 yr 11 mo | ProductU-2553 | |
| 12090231 | in 4 yr 11 mo | U-2553 | |
| 9603860 | in 4 yr 11 mo | U-2553 | |
| 10179140 | in 4 yr 11 mo | U-2553 | |
| 11413249 | in 4 yr 11 mo | U-2553 | |
| 11951213 | in 4 yr 11 mo | U-2553 | |
| 11351122 | in 4 yr 11 mo | Product | |
| 11123299 | in 4 yr 11 mo | Product | |
| 11439598 | in 4 yr 11 mo | Product | |
| 11291633 | in 4 yr 11 mo | Product | |
| 10987364 | in 4 yr 11 mo | Product | |
| 11291632 | in 4 yr 11 mo | Product | |
| 11504334 | in 4 yr 11 mo | Product | |
| 11478487 | in 4 yr 11 mo | Product | |
| 12280151 | in 4 yr 11 mo | Product |
Approval history
FDA approval span
First approval
7 yr 4 mo ago
Most recent approval
4 yr 2 mo ago
Approvals span 2019–2022 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Drospirenone: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
