Orange Book product · Brand (NDA)
VELTASSA
PATIROMER SORBITEX CALCIUM
At a glance
Oct 21, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 21, 2015
10 yr 10 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Oct 02, 2026
in 4 mo
Patent 8216560 expires
Listed method-of-use patent (U-1766) expiration.
Mar 14, 2027
in 9 mo
Patent 8282913 expires
Listed drug product patent expiration.
May 29, 2027
in 11 mo
Patent 8147873 expires
Listed drug product patent expiration.
Jun 20, 2028
in 2 yr
Patent 8337824 expires
Listed drug substance patent expiration.
May 29, 2030
in 4 yr
Patent 11123363 expires
Listed method-of-use patent (U-1766) expiration.
Oct 08, 2033
in 7 yr 5 mo
Patent 9492476 expires
Listed method-of-use patent (U-1766) expiration.
Oct 08, 2033
in 7 yr 5 mo
Patent 9925212 expires
Listed method-of-use patent (U-1766) expiration.
Oct 08, 2033
in 7 yr 5 mo
Pharmaceutical detail
Active ingredient
PATIROMER SORBITEX CALCIUM
Strength
EQ 16.8GM BASE/PACKET
Dosage form
POWDER
Route
ORAL
TE code
Not listed
Application
NDA 205739
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Oct 02, 2026
in 4 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8216560 | Mar 14, 2027 | in 9 mo | U-1766 |
| 8282913 | May 29, 2027 | in 11 mo | Product |
| 8147873 | Jun 20, 2028 | in 2 yr | Product |
| 8337824 | May 29, 2030 | in 4 yr | SubstanceU-1766 |
| 11123363 | Oct 08, 2033 | in 7 yr 5 mo | U-1766 |
| 9492476 | Oct 08, 2033 | in 7 yr 5 mo | U-1766 |
| 9925212 | Oct 08, 2033 | in 7 yr 5 mo | U-1766 |
