Orange Book product · Brand (NDA)
ADLARITY
DONEPEZIL HYDROCHLORIDE
At a glance
Mar 11, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 11, 2022
4 yr 4 mo ago
Today
Patent 12161767 expires
Listed drug substance patent expiration.
Dec 30, 2036
in 10 yr 8 mo
Patent 12168075 expires
Listed method-of-use patent (U-3334) expiration.
Dec 30, 2036
in 10 yr 8 mo
Patent 11679086 expires
Listed method-of-use patent (U-3334) expiration.
May 26, 2037
in 11 yr 1 mo
Patent 10016372 expires
Listed method-of-use patent (U-3334) expiration.
Jul 26, 2037
in 11 yr 3 mo
Patent 10300025 expires
Listed drug product patent expiration.
Jul 26, 2037
in 11 yr 3 mo
Patent 10307379 expires
Listed drug product patent expiration.
Jul 26, 2037
in 11 yr 3 mo
Patent 11103463 expires
Listed method-of-use patent (U-3334) expiration.
Jul 26, 2037
in 11 yr 3 mo
Patent 9993466 expires
Listed drug product patent expiration.
Jul 26, 2037
in 11 yr 3 mo
Patent 11648214 expires
Listed drug product patent expiration.
Sep 23, 2037
in 11 yr 5 mo
Patent 10835499 expires
Listed drug product patent expiration.
May 20, 2038
in 12 yr 1 mo
Patent 10966936 expires
Listed drug product patent expiration.
Aug 11, 2038
in 12 yr 4 mo
Pharmaceutical detail
Active ingredient
DONEPEZIL HYDROCHLORIDE
Strength
5MG/DAY
Dosage form
SYSTEM
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 212304
Product number
001
Marketing status
DISCN
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.
- 2010ARICEPTBrand (NDA)
NDA 022568 · EISAI INC
- 2004ARICEPTBrand (NDA)
NDA 021719 · EISAI INC
- 2004ARICEPT ODTBrand (NDA)
NDA 021720 · EISAI INC
- 1996ARICEPTBrand (NDA)
NDA 020690 · EISAI INC
- 2018DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 205269 · HISUN PHARM HANGZHOU
- 2017DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204609 · CADILA PHARMS LTD
- 2017DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 202410 · HISUN PHARM HANGZHOU
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204831 · UNICHEM
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203656 · UNICHEM
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203419 · CHARTWELL RX
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203713 · DEXCEL
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203114 · OSMOTICA PHARM US
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12161767 | Dec 30, 2036 | in 10 yr 8 mo | SubstanceProductU-3334 |
| 12168075 | Dec 30, 2036 | in 10 yr 8 mo | U-3334 |
| 11679086 | May 26, 2037 | in 11 yr 1 mo | U-3334 |
| 10016372 | Jul 26, 2037 | in 11 yr 3 mo | U-3334 |
| 10300025 | Jul 26, 2037 | in 11 yr 3 mo | Product |
| 10307379 | Jul 26, 2037 | in 11 yr 3 mo | Product |
| 11103463 | Jul 26, 2037 | in 11 yr 3 mo | U-3334 |
| 9993466 | Jul 26, 2037 | in 11 yr 3 mo | Product |
| 11648214 | Sep 23, 2037 | in 11 yr 5 mo | ProductU-3334 |
| 10835499 | May 20, 2038 | in 12 yr 1 mo | ProductU-3334 |
| 10966936 | Aug 11, 2038 | in 12 yr 4 mo | ProductU-3334 |
