Orange Book product · Brand (NDA)
SILENOR
DOXEPIN HYDROCHLORIDE
At a glance
Mar 17, 2010
Approved
Brand (NDA)
Application
AB
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2010
16 yr 6 mo ago
Today
Patent 10238620 expires
Listed method-of-use patent (U-620) expiration.
May 18, 2027
in 11 mo
Patent 10653662 expires
Listed method-of-use patent (U-620) expiration.
May 18, 2027
in 11 mo
Patent 12083090 expires
Listed method-of-use patent (U-620) expiration.
May 18, 2027
in 11 mo
Patent 9486437 expires
Listed method-of-use patent (U-620) expiration.
May 18, 2027
in 11 mo
Patent 9861607 expires
Listed method-of-use patent (U-620) expiration.
May 18, 2027
in 11 mo
Patent 10653660 expires
Listed method-of-use patent (U-620) expiration.
Jul 20, 2027
in 1 yr 1 mo
Patent 11110074 expires
Listed method-of-use patent (U-620) expiration.
Jul 20, 2027
in 1 yr 1 mo
Patent 9572814 expires
Listed method-of-use patent (U-620) expiration.
Jul 20, 2027
in 1 yr 1 mo
Patent 7915307 expires
Listed method-of-use patent (U-620) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 11234954 expires
Listed method-of-use patent (U-620) expiration.
Jan 18, 2028
in 1 yr 7 mo
Patent 10548871 expires
Listed method-of-use patent (U-620) expiration.
Apr 11, 2028
in 1 yr 10 mo
Patent 11096920 expires
Listed method-of-use patent (U-620) expiration.
Apr 11, 2028
in 1 yr 10 mo
Patent 9907780 expires
Listed drug product patent expiration.
Apr 11, 2028
in 1 yr 10 mo
Patent 9107898 expires
Listed method-of-use patent (U-620) expiration.
May 01, 2028
in 1 yr 11 mo
Patent 9532971 expires
Listed drug product patent expiration.
Jun 01, 2029
in 3 yr
Patent 8513299 expires
Listed method-of-use patent (U-620) expiration.
Sep 07, 2030
in 4 yr 3 mo
Pharmaceutical detail
Active ingredient
DOXEPIN HYDROCHLORIDE
Strength
EQ 3MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022036
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.
- —DOXEPIN HYDROCHLORIDEBrand (NDA)
NDA 016987 · NEW RIVER
- 2023DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217975 · UNIQUE
- 2023DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217688 · MICRO LABS
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215113 · MSN
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 213796 · ADAPTIS
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215483 · JUBILANT CADISTA
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215710 · MANKIND PHARMA
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215076 · ALEMBIC
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 214908 · APPCO
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211619 · IXORA LIFESCIENCE
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211618 · VELZEN PHARMA PVT
- 2020DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 210675 · EPIC PHARMA LLC
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10238620 | May 18, 2027 | in 11 mo | U-620 |
| 10653662 | May 18, 2027 | in 11 mo | U-620 |
| 12083090 | May 18, 2027 | in 11 mo | U-620 |
| 9486437 | May 18, 2027 | in 11 mo | U-620 |
| 9861607 | May 18, 2027 | in 11 mo | U-620 |
| 10653660 | Jul 20, 2027 | in 1 yr 1 mo | U-620 |
| 11110074 | Jul 20, 2027 | in 1 yr 1 mo | U-620 |
| 9572814 | Jul 20, 2027 | in 1 yr 1 mo | U-620 |
| 7915307 | Aug 24, 2027 | in 1 yr 2 mo | U-620 |
| 11234954 | Jan 18, 2028 | in 1 yr 7 mo | U-620 |
| 10548871 | Apr 11, 2028 | in 1 yr 10 mo | U-620 |
| 11096920 | Apr 11, 2028 | in 1 yr 10 mo | U-620 |
| 9907780 | Apr 11, 2028 | in 1 yr 10 mo | Product |
| 9107898 | May 01, 2028 | in 1 yr 11 mo | U-620 |
| 9532971 | Jun 01, 2029 | in 3 yr | Product |
| 8513299 | Sep 07, 2030 | in 4 yr 3 mo | U-620 |
