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Doxepin hydrochloride - Generic Drug Details
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, 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 sixteen 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: | 16 |
| US Patents: | 9 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 60 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 28 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 15 |
| Patent Applications: | 1,078 |
| 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 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) |
Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071422-001 | Nov 9, 1987 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Par Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071608-001 | Nov 9, 1987 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Amneal Pharms Co | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482-004 | Jun 28, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 |
|---|---|---|---|---|---|---|---|
| Pernix | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | ➤ Sign Up | ➤ Sign Up |
| Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-001 | Approved Prior to Jan 1, 1982 | ➤ Sign Up | ➤ Sign Up |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-003 | Approved Prior to Jan 1, 1982 | ➤ Sign Up | ➤ Sign Up |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-001 | Approved Prior to Jan 1, 1982 | ➤ Sign Up | ➤ Sign Up |
| Pernix | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for doxepin hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2687118 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007142811 | ➤ Sign Up |
| Japan | 2018044006 | ➤ Sign Up |
| Canada | 2687124 | ➤ Sign Up |
| Canada | 2721133 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
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ISSN: 2162-2639
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Terms & Conditions
Site Map
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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