DrugPatentWatch Database Preview
Doxepin hydrochloride - Generic Drug Details
What are the generic drug sources for doxepin hydrochloride and what is the scope of patent protection?
Doxepin hydrochloride
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, 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, Mylan, Actavis Elizabeth, and Currax, and is included in fifty-six NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Doxepin hydrochloride has sixteen patent family members in four countries.
There are seven drug master file entries for doxepin hydrochloride. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for doxepin hydrochloride
| International Patents: | 16 |
| US Patents: | 10 |
| Tradenames: | 4 |
| Applicants: | 20 |
| NDAs: | 56 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 21 |
| Bulk Api Vendors: | 59 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,946 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxepin hydrochloride |
| DailyMed Link: | doxepin hydrochloride at DailyMed |
Recent Clinical Trials for doxepin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aalborg University | N/A |
| University of Balamand | Phase 4 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Recent Litigation for doxepin hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
| Somaxon Pharmaceuticals Inc. v. Par Pharmaceutical Inc. | 2011-05-26 |
| Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC | 2010-12-15 |
Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 6MG | TABLET; ORAL |
| Start Trial | Start Trial | 3MG | TABLET; ORAL |
| Start Trial | Start Trial | 6MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 hydrochloride |
| (3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride |
| (e)-doxepin hydrochloride |
| 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-, hydrochloride |
| 11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin hydrochloride |
| 11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepine hydrochloride |
| 1229-29-4 |
| 20917-44-6 |
| 229D294 |
| 25197-84-6 |
| 4698-39-9 |
| A804993 |
| AB0109368 |
| AC1O4WGB |
| Adapin |
| AKOS015895087 |
| Aponal |
| BG0175 |
| C19H21NO.HCl |
| CAS-1229-29-4 |
| CCG-220263 |
| CCG-221643 |
| CHEBI:4711 |
| CHEMBL1200462 |
| CPD000058230 |
| CS-2972 |
| CU61C5RH24 |
| Curatin |
| D 4526 |
| D00814 |
| Dibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine, N,N-dimethyl-, hydrochloride |
| 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) |
| Doxepin (Hydrochloride) |
| Doxepin for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Doxepin HCl |
| 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, ~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 |
| Doxepine hydrochloride |
| DSSTox_CID_25145 |
| DSSTox_GSID_45145 |
| DSSTox_RID_80701 |
| DTXSID8045145 |
| EINECS 214-966-8 |
| EU-0100339 |
| HMS1568F08 |
| HY-B0725 |
| I06-0502 |
| J10288 |
| Jsp001539 |
| KS-5094 |
| LP00339 |
| LS-61639 |
| MF 10 HCl |
| MFCD00079135 |
| MLS000069794 |
| MLS001148235 |
| MLS002207250 |
| MLS002222181 |
| MLS002548858 |
| MolPort-003-872-120 |
| N,N-Dimethyldibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine hydrochloride |
| NC00447 |
| NCGC00015344-03 |
| NCGC00024623-04 |
| NCGC00093778-01 |
| NCGC00093778-02 |
| NCGC00261024-01 |
| Novoxapin |
| Novoxapin hydrochloride |
| NSC-108160 |
| Opera_ID_675 |
| P-3693A |
| Prestwick_187 |
| Q-201044 |
| Quitaxon |
| SAM002264608 |
| SBB005916 |
| SCHEMBL60287 |
| Silenor |
| Sinequan |
| Sinequan (TN) |
| Sinequin |
| SMR000058230 |
| SR-01000075551 |
| SR-01000075551-1 |
| SR-01000075551-5 |
| ST025239 |
| Toruan |
| Tox21_110130 |
| Tox21_110130_1 |
| Tox21_500339 |
| trans-Doxepin hydrochloride |
| UNII-3U9A0FE9N5 component MHNSPTUQQIYJOT-SJDTYFKWSA-N |
| UNII-CU61C5RH24 |
| Zonalon |
| Zonalon (TN) |
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SILENOR | TABLET;ORAL | doxepin hydrochloride | 022036 | 2010-09-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharm Assoc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CONCENTRATE;ORAL | 075924-001 | Jan 15, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Purepac Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 073055-001 | Dec 28, 1990 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070955-001 | May 15, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for doxepin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for doxepin hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2687124 | Start Trial |
| Japan | 2013237694 | Start Trial |
| European Patent Office | 2026792 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007142810 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.