FDA Orange Book
Is there a generic for Intrarosa?
Intrarosa contains prasterone. 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 Intrarosa (prasterone). The Orange Book shows its last listed patent expires March 19, 2031.
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Intrarosa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| insert, vaginal | 6.5MG | Marketed (Rx) | None | 0 | None |
NDA 208470, held by MILLICENT PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Intrarosa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8629129 | August 7, 2028 | Drug product | None | 208470 |
| 8957054 | January 8, 2030 | Method of use | U-1922 | 208470 |
| 8268806 | March 19, 2031 | Drug product | None | 208470 |
Intrarosa NDC codes
Questions
Is there a generic for Intrarosa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Intrarosa (prasterone). The Orange Book shows its last listed patent expires March 19, 2031.
What is the generic name for Intrarosa?
The active ingredient in Intrarosa is prasterone, per the FDA Orange Book.
When does the Intrarosa patent expire?
The last patent listed for Intrarosa in the Orange Book expires March 19, 2031. 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.