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Doxepin hydrochloride - Generic Drug Details
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What are the generic drug sources for doxepin hydrochloride and what is the scope of doxepin hydrochloride patent protection?
Doxepin hydrochloride
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Pfizer, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, and Pernix Theraps Llc, and is included in sixty NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Doxepin hydrochloride has fifteen patent family members in four countries.
There are seven drug master file entries for doxepin hydrochloride. Twenty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for doxepin hydrochloride
| International Patents: | 15 |
| US Patents: | 9 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 60 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 28 |
| Bulk Api Vendors: | 75 |
| Clinical Trials: | 14 |
| Patent Applications: | 1,017 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxepin hydrochloride |
| DailyMed Link: | doxepin hydrochloride at DailyMed |
Pharmacology for doxepin hydrochloride
| Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for doxepin hydrochloride
Synonyms for doxepin hydrochloride
| (3-(6H-dibenzo[c,f]oxepin-11-ylidene)propyl)dimethylamine, chloride |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethyl-1-propanamine hydrochloride |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethyl-propan-1-amine hydrochloride |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine hydrochloride |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride |
| (3e)-3-(Dibenzo[b,E]oxepin-11(6h)-Ylidene)-N,N-Dimethylpropan-1-Amine |
| (3E)-3-dibenzo[b,e]oxepin-11(6H)-ylidene-N,N-dimethylpropan-1-amine |
| (3Z)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-di(methyl)propan-1-amine |
| (3Z)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine |
| (E)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N,N-dimethylpropan-1-amine |
| (e)-doxepin |
| (e)-doxepin hydrochloride |
| [11C]-doxepin |
| [11C]doxepin |
| 1-Propanamine, 3-dibenz(b,e)oxepin-11-(6H)-ylidene-N,N-dimethyl-dimethyl-, hydrochloride, (E)- |
| 1-Propanamine, 3-dibenz(b,e)oxepin-11(6H)-ylidene-N,N-dimethyl- |
| 1-Propanamine, 3-dibenz(b,e)oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride |
| 11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin hydrochloride |
| 11-(3-(Dimethylamino)propylidene)-6H-dibenz(b,e)oxepine |
| 11-(3-Dimethylamino-propyliden)-6,11-dihydro-dibenz(b,e)oxipin |
| 11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz(b,e)oxipin |
| 11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepine hydrochloride |
| 1229-29-4 |
| 1668-19-5 |
| 20917-44-6 |
| 229D294 |
| 25197-84-6 |
| 3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine |
| 3-dibenzo[b,e]oxepin-11(6H)-ylidene-N,N-dimethylpropan-1-amine |
| 3607-34-9 |
| 4698-39-9 |
| 5EH |
| 851NLB57HQ |
| A804993 |
| AB0109368 |
| AC1LDI63 |
| AC1O4WGB |
| Adapin |
| Adapine (TN) |
| AJ-08007 |
| AK-60057 |
| AK-70938 |
| AKOS015895087 |
| AKOS016014904 |
| Aponal |
| Aponal (TN) |
| AX8126881 |
| BC225584 |
| BDBM112780 |
| BG0175 |
| BPBio1_000118 |
| BRD-K36616567-003-01-5 |
| BRD-K54462405-003-03-3 |
| BSPBio_000106 |
| C06971 |
| C19H21NO |
| C19H21NO.HCl |
| CAS-1229-29-4 |
| CCG-204434 |
| CCG-220263 |
| CCG-221643 |
| CCRIS 9176 |
| CHEBI:4711 |
| CHEMBL1200462 |
| CHEMBL860 |
| Cidoxepin [INN] |
| Cidoxepina |
| Cidoxepinum |
| cis-N-(3-(6H-Dibenz(b,e)oxepin-11-yliden)propyl)-N,N-dimethylamin |
| CPD000058230 |
| CS-2972 |
| CU61C5RH24 |
| Curatin |
| D 4526 |
| D00814 |
| D06EUH |
| D06FES |
| D07875 |
| Deptran |
| Deptran (TN) |
| Dibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine, N,N-dimethyl-, hydrochloride |
| Dibenz(b,e)oxepin-delta(sup 11(6H)),gamma-propylamine, N,N-dimethyl- |
| Dibenz(b,e)oxepin-delta11(6H),gamma-propylamine, N,N-dimethyl-, hydrochloride |
| Dibenz(b,e)oxepin-delta11(6H),gamma-propylamine, N,N-dimethyl-, hydrochloride (8CI) |
| dimethyl({3-[(2E)-9-oxatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene]propyl})amine |
| DIMETHYL({3-[(2E)-9-OXATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3,5,7,11,13-HEXAEN-2-YLIDENE]PROPYL})AMINE |
| dimethyl(3-{9-oxatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene}propyl)amine |
| doxepin |
| Doxepin (Hydrochloride) |
| Doxepin (INN) |
| Doxepin (Z)-isomer |
| Doxepin [INN:BAN] |
| Doxepin [USAN] |
| Doxepin for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Doxepin HCl |
| Doxepin hydrochlorid |
| Doxepin hydrochloride (E)-isomer |
| Doxepin hydrochloride (USP) |
| Doxepin hydrochloride [USAN:USP] |
| Doxepin Hydrochloride [USAN] |
| Doxepin Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| Doxepin Hydrochloride, |
| Doxepin hydrochloride, ~85% E-isomer basis, >=98% (GC), 15% Z-isomer basis, powder |
| Doxepin hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Doxepin hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Doxepin, (E)- |
| Doxepin, Hydrochloride |
| Doxepina |
| Doxepina [INN-Spanish] |
| Doxepine |
| Doxepine hydrochloride |
| Doxepinum |
| Doxepinum [INN-Latin] |
| DR000955 |
| DSSTox_CID_25145 |
| DSSTox_GSID_45145 |
| DSSTox_RID_80701 |
| DTXSID7022966 |
| DTXSID8045145 |
| E-DOXEPIN |
| EINECS 214-966-8 |
| EU-0100339 |
| GTPL1225 |
| GTPL3958 |
| HMS1568F08 |
| HSDB 3069 |
| HY-B0725 |
| I06-0502 |
| J10288 |
| Jsp001539 |
| KB-233534 |
| KS-5094 |
| L000699 |
| Lopac-D-4526 |
| Lopac0_000339 |
| LP00339 |
| LS-174582 |
| LS-61638 |
| LS-61639 |
| MF 10 |
| MF 10 HCl |
| MFCD00079135 |
| MLS000069794 |
| MLS001148235 |
| MLS002207250 |
| MLS002222181 |
| MLS002548858 |
| MOLI001594 |
| MolPort-003-872-120 |
| N,N-Dimethyldibenz(b,e)oxepin-delta(11(6H),gamma)-propylamine |
| N,N-Dimethyldibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine hydrochloride |
| NC00447 |
| NCGC00015344-01 |
| NCGC00015344-02 |
| NCGC00015344-03 |
| NCGC00015344-04 |
| NCGC00024623-01 |
| NCGC00024623-04 |
| NCGC00093778-01 |
| NCGC00093778-02 |
| NCGC00162127-01 |
| NCGC00261024-01 |
| Novoxapin |
| Novoxapin hydrochloride |
| NSC-108160 |
| Opera_ID_675 |
| P-3693A |
| PL047943 |
| Prestwick_187 |
| Prestwick2_000263 |
| Prestwick3_000263 |
| Q-201044 |
| Quitaxon |
| SAM002264608 |
| SBB005916 |
| SCHEMBL116895 |
| SCHEMBL60287 |
| Silenor |
| Sinequan |
| Sinequan (TN) |
| Sinequan, Zonalon |
| Sinequin |
| Sinquan (TN) |
| SMR000058230 |
| SR-01000075551 |
| SR-01000075551-1 |
| ST025239 |
| Tocris-0508 |
| Toruan |
| Tox21_110130 |
| Tox21_110130_1 |
| Tox21_500339 |
| trans-doxepin |
| trans-Doxepin hydrochloride |
| Triadapin |
| UNII-3U9A0FE9N5 component MHNSPTUQQIYJOT-SJDTYFKWSA-N |
| UNII-5ASJ6HUZ7D component ODQWQRRAPPTVAG-GZTJUZNOSA-N |
| UNII-851NLB57HQ |
| UNII-CU61C5RH24 |
| US8629135, SW-07 |
| Xepin (TN) |
| ZINC1331 |
| Zonalon |
| Zonalon (TN) |
Tentative approvals for DOXEPIN HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 3MG | TABLET; ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 6MG | TABLET; ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 6MG | TABLET; ORAL |
US Patents and Regulatory Information for doxepin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070954-001 | May 15, 1986 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Sun Pharm Industries | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071521-001 | Feb 18, 1988 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Mylan Pharms Inc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070791-002 | May 13, 1986 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Quantum Pharmics | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070973-001 | Sep 29, 1987 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for doxepin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-007 | Approved Prior to Jan 1, 1982 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-002 | Approved Prior to Jan 1, 1982 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for doxepin hydrochloride
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,463,181 | Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders | ➤ Try a Free Trial |
| 9,498,462 | Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders | ➤ Try a Free Trial |
| 9,801,847 | Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for doxepin hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2148659 | ➤ Try a Free Trial |
| Canada | 2687124 | ➤ Try a Free Trial |
| European Patent Office | 2026792 | ➤ Try a Free Trial |
| Canada | 2693992 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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