Orange Book product · Brand (NDA)
OPSUMIT
MACITENTAN
At a glance
Oct 18, 2013
Approved
Brand (NDA)
Application
AB
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2013
12 yr 10 mo ago
Patent 7094781 expires
Listed drug substance patent expiration.
Dec 05, 2025
7 mo ago
Patent 7094781*PED expires
Listed listed patent expiration.
Jun 05, 2026
14 d ago
Today
Patent 10946015 expires
Listed drug product patent expiration.
Sep 11, 2026
in 3 mo
Patent 10946015*PED expires
Listed listed patent expiration.
Mar 11, 2027
in 9 mo
Patent 9265762 expires
Listed drug product patent expiration.
May 29, 2027
in 11 mo
Patent 9265762*PED expires
Listed listed patent expiration.
Nov 29, 2027
in 1 yr 6 mo
Exclusivity ends · M-187
New use / labeling-change exclusivity (3 years)
Feb 28, 2028
in 1 yr 9 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Aug 28, 2028
in 2 yr 3 mo
Patent 8367685 expires
Listed drug product patent expiration.
Oct 04, 2028
in 2 yr 4 mo
Patent 8367685*PED expires
Listed listed patent expiration.
Apr 04, 2029
in 2 yr 10 mo
Patent 8268847 expires
Listed method-of-use patent (U-1446) expiration.
Apr 18, 2029
in 2 yr 10 mo
Patent 8268847*PED expires
Listed listed patent expiration.
Oct 18, 2029
in 3 yr 5 mo
Pharmaceutical detail
Active ingredient
MACITENTAN
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 204410
Product number
001
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.
- 2026MACITENTANGeneric (ANDA)
ANDA 211000 · AMNEAL
- 2026MACITENTANGeneric (ANDA)
ANDA 211187 · TEVA PHARMS USA INC
- 2025MACITENTANGeneric (ANDA)
ANDA 211161 · MYLAN
- 2025MACITENTANGeneric (ANDA)
ANDA 211026 · SEASONS BIOTECH
- 2025MACITENTANGeneric (ANDA)
ANDA 211120 · LAURUS
- 2025MACITENTANGeneric (ANDA)
ANDA 211123 · SUN PHARM
- 2025MACITENTANGeneric (ANDA)
ANDA 211136 · MSN
- 2025MACITENTANGeneric (ANDA)
ANDA 211128 · ALEMBIC
- 2024MACITENTANGeneric (ANDA)
ANDA 211107 · TORRENT
- 2024MACITENTANGeneric (ANDA)
ANDA 211195 · APOTEX
- 2023MACITENTANGeneric (ANDA)
ANDA 211198 · AUROBINDO PHARMA LTD
- 2021MACITENTANGeneric (ANDA)
ANDA 211224 · ZYDUS LIFESCIENCES
Marketing exclusivity (2)
- M-187New use / labeling-change exclusivity (3 years)
Feb 28, 2028
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Aug 28, 2028
in 2 yr 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7094781 | Dec 05, 2025 | 7 mo ago | SubstanceProduct |
| 7094781*PED | Jun 05, 2026 | 14 d ago | |
| 10946015 | Sep 11, 2026 | in 3 mo | ProductU-1445 |
| 10946015*PED | Mar 11, 2027 | in 9 mo | |
| 9265762 | May 29, 2027 | in 11 mo | ProductU-1820 |
| 9265762*PED | Nov 29, 2027 | in 1 yr 6 mo | |
| 8367685 | Oct 04, 2028 | in 2 yr 4 mo | ProductU-1445 |
| 8367685*PED | Apr 04, 2029 | in 2 yr 10 mo | |
| 8268847 | Apr 18, 2029 | in 2 yr 10 mo | U-1446 |
| 8268847*PED | Oct 18, 2029 | in 3 yr 5 mo |
