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FDA Orange Book · active-ingredient family

Doxepin hydrochloride

Doxepin hydrochloride is approved as 5 brand and 78 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SILENOR · NDA 022036

5

Brand (NDA)

78

Generics (ANDA)

16

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, concentrate, cream, tablet

ProductApplicantApplicationTEApproved
SILENORRLD×2CURRAXNDA 022036ABMar 17, 2010
ZONALONRLDMYLANNDA 020126ABApr 01, 1994
SINEQUANRLD×6PFIZERNDA 016798—Approved Prior to Jan 1, 1982
SINEQUANRLDPFIZERNDA 017516—Approved Prior to Jan 1, 1982
DOXEPIN HYDROCHLORIDE×6NEW RIVERNDA 016987—Approved Prior to Jan 1, 1982

Generic (ANDA) products (78)

ProductApplicantApplicationTEApproved
DOXEPIN HYDROCHLORIDESUN PHARMA CANADAANDA 213919ABApr 28, 2026
DOXEPIN HYDROCHLORIDE×2TAROANDA 219058ABAug 06, 2025
DOXEPIN HYDROCHLORIDE×2AUROBINDO PHARMA LTDANDA 216041ABJul 25, 2024
DOXEPIN HYDROCHLORIDE×2AJANTA PHARMA LTDANDA 218564ABJul 01, 2024
DOXEPIN HYDROCHLORIDE×5UNIQUEANDA 217975ABAug 21, 2023
DOXEPIN HYDROCHLORIDEAMNEALANDA 212357ABAug 16, 2023
DOXEPIN HYDROCHLORIDE×2ZYDUS LIFESCIENCESANDA 202761ABAug 16, 2023
DOXEPIN HYDROCHLORIDE×5MICRO LABSANDA 217688ABJun 27, 2023
DOXEPIN HYDROCHLORIDE×2MSNANDA 214823BXApr 03, 2023
DOXEPIN HYDROCHLORIDE×5ZYDUS LIFESCIENCESANDA 210700BXMar 23, 2023
DOXEPIN HYDROCHLORIDEZYDUS LIFESCIENCESANDA 210140BXMar 21, 2023
DOXEPIN HYDROCHLORIDETEVA PHARMSANDA 215408ABFeb 17, 2023
DOXEPIN HYDROCHLORIDE×5MSNANDA 215113ABJun 24, 2022
DOXEPIN HYDROCHLORIDEADAPTISANDA 213796—Apr 19, 2022
DOXEPIN HYDROCHLORIDE×5JUBILANT CADISTAANDA 215483ABMar 14, 2022
DOXEPIN HYDROCHLORIDE×5MANKIND PHARMAANDA 215710ABFeb 09, 2022
DOXEPIN HYDROCHLORIDE×5ALEMBICANDA 215076ABApr 21, 2021
DOXEPIN HYDROCHLORIDE×5APPCOANDA 214908ABApr 01, 2021
DOXEPIN HYDROCHLORIDE×5IXORA LIFESCIENCEANDA 211619ABMar 09, 2021
DOXEPIN HYDROCHLORIDEVELZEN PHARMA PVTANDA 211618ABMar 01, 2021
DOXEPIN HYDROCHLORIDE×5EPIC PHARMA LLCANDA 210675ABOct 16, 2020
DOXEPIN HYDROCHLORIDE×5CHARTWELL RXANDA 210268ABSep 04, 2020
DOXEPIN HYDROCHLORIDE×5AIPING PHARM INCANDA 213474ABJul 28, 2020
DOXEPIN HYDROCHLORIDE×5LANNETT CO INCANDA 212997—Jul 24, 2020
DOXEPIN HYDROCHLORIDE×2STRIDES PHARMA INTLANDA 202510ABJul 24, 2020
DOXEPIN HYDROCHLORIDE×5TAROANDA 213063—Jul 01, 2020
DOXEPIN HYDROCHLORIDE×5AJANTA PHARMA LTDANDA 212624ABSep 13, 2019
DOXEPIN HYDROCHLORIDE×5AUROBINDO PHARMA LTDANDA 211603ABMar 27, 2019
DOXEPIN HYDROCHLORIDE×5AMNEAL PHARMS COANDA 207482ABJun 28, 2017
DOXEPIN HYDROCHLORIDE×2RK PHARMAANDA 202337ABJan 20, 2016
DOXEPIN HYDROCHLORIDE×2ACTAVIS ELIZABETHANDA 201951ABJul 26, 2013
DOXEPIN HYDROCHLORIDEPHARM ASSOCANDA 075924—Jan 15, 2004
DOXEPIN HYDROCHLORIDELANNETT CO INCANDA 074721—Dec 29, 1998
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 072985—Mar 29, 1991
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 072986—Mar 29, 1991
DOXEPIN HYDROCHLORIDEWATSON LABS TEVAANDA 072987—Mar 29, 1991
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 073054—Dec 28, 1990
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 072109—Dec 28, 1990
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 073055—Dec 28, 1990
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 072375—Mar 15, 1989
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 072376—Mar 15, 1989
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 072386—Sep 08, 1988
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 072110—Sep 08, 1988
DOXEPIN HYDROCHLORIDEPUREPAC PHARMANDA 072387—Sep 08, 1988
DOXEPIN HYDROCHLORIDEPHARMOBEDIENT CNSLTGANDA 071918—Jul 20, 1988
DOXEPIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071502—Feb 18, 1988
DOXEPIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071653—Feb 18, 1988
DOXEPIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071654—Feb 18, 1988
DOXEPIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071521—Feb 18, 1988
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071763—Feb 09, 1988
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071764—Feb 09, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071685—Jan 05, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071686—Jan 05, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071673—Jan 05, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071674—Jan 05, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071675—Jan 05, 1988
DOXEPIN HYDROCHLORIDEDAVA PHARMS INCANDA 071676—Jan 05, 1988
DOXEPIN HYDROCHLORIDE×6PH HEALTHANDA 071422—Nov 09, 1987
DOXEPIN HYDROCHLORIDETEVA PHARMSANDA 071609—Nov 09, 1987
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 070972—Sep 29, 1987
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 070973—Sep 29, 1987
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 070931—Sep 29, 1987
DOXEPIN HYDROCHLORIDEQUANTUM PHARMICSANDA 070932—Sep 29, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071485—Apr 30, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071486—Apr 30, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071238—Apr 30, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071326—Apr 30, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 071239—Apr 30, 1987
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 070952—Mar 04, 1987
DOXEPIN HYDROCHLORIDESANDOZANDA 071487—Mar 02, 1987
DOXEPIN HYDROCHLORIDESANDOZANDA 071562—Mar 02, 1987
DOXEPIN HYDROCHLORIDESANDOZANDA 070827—May 15, 1986
DOXEPIN HYDROCHLORIDESANDOZANDA 070828—May 15, 1986
DOXEPIN HYDROCHLORIDESANDOZANDA 070825—May 15, 1986
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 070953—May 15, 1986
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 070954—May 15, 1986
DOXEPIN HYDROCHLORIDEWATSON LABSANDA 070955—May 15, 1986
DOXEPIN HYDROCHLORIDE×5MYLAN PHARMS INCANDA 070791ABMay 13, 1986

Listed patents (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9861607May 18, 2027in 11 mo
U-620
12083090May 18, 2027in 11 mo
U-620
9486437May 18, 2027in 11 mo
U-620
10238620May 18, 2027in 11 mo
U-620
10653662May 18, 2027in 11 mo
U-620
9572814Jul 20, 2027in 1 yr 1 mo
U-620
10653660Jul 20, 2027in 1 yr 1 mo
U-620
11110074Jul 20, 2027in 1 yr 1 mo
U-620
7915307Aug 24, 2027in 1 yr 2 mo
U-620
11234954Jan 18, 2028in 1 yr 7 mo
U-620
10548871Apr 11, 2028in 1 yr 10 mo
U-620
11096920Apr 11, 2028in 1 yr 10 mo
U-620
9907780Apr 11, 2028in 1 yr 10 mo
Product
9107898May 01, 2028in 1 yr 11 mo
U-620
9532971Jun 01, 2029in 3 yr
Product
8513299Sep 07, 2030in 4 yr 3 mo
U-620

Doxepin hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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