Orange Book product · Brand (NDA)
AZILECT
RASAGILINE MESYLATE
At a glance
May 16, 2006
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 16, 2006
20 yr 5 mo ago
Today
Patent 7572834 expires
Listed drug product patent expiration.
Dec 05, 2026
in 6 mo
Patent 7815942 expires
Listed drug substance patent expiration.
Aug 27, 2027
in 1 yr 2 mo
Pharmaceutical detail
Active ingredient
RASAGILINE MESYLATE
Strength
EQ 0.5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021641
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025RASAGILINE MESYLATEGeneric (ANDA)
ANDA 210150 · TORRENT
- 2024RASAGILINE MESYLATEGeneric (ANDA)
ANDA 208866 · MACLEODS PHARMS LTD
- 2024RASAGILINE MESYLATEGeneric (ANDA)
ANDA 218163 · RISING
- 2021RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201942 · CARNEGIE
- 2019RASAGILINE MESYLATEGeneric (ANDA)
ANDA 206153 · REGCON HOLDINGS
- 2019RASAGILINE MESYLATEGeneric (ANDA)
ANDA 207004 · MICRO LABS
- 2018RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201892 · CHARTWELL RX
- 2017RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201889 · ALKEM LABS LTD
- 2017RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201971 · AUROBINDO PHARMA USA
- 2016RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201970 · ORBION PHARMS
- 2013RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201950 · APOTEX INC
- 2013RASAGILINE MESYLATEGeneric (ANDA)
ANDA 201823 · WATSON LABS INC
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7572834 | Dec 05, 2026 | in 6 mo | Product |
| 7815942 | Aug 27, 2027 | in 1 yr 2 mo | SubstanceProductU-219 |

