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SILENOR Drug Profile
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When do Silenor patents expire, and when can generic versions of Silenor launch?
Silenor is a drug marketed by Currax and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixteen patent family members in four countries.
The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Silenor
A generic version of SILENOR was approved as doxepin hydrochloride by MYLAN PHARMS INC on January 25th, 2020.
Summary for SILENOR
| International Patents: | 16 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 2 |
| Patent Applications: | 732 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SILENOR |
| Drug Sales Revenues: | Drug sales revenues for SILENOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SILENOR |
| DailyMed Link: | SILENOR at DailyMed |
Recent Clinical Trials for SILENOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Balamand | Phase 4 |
| Pernix Theraputics LLC | Phase 4 |
| Henry Ford Hospital | Phase 4 |
Recent Litigation for SILENOR
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 |
Synonyms for SILENOR
| (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 |
| 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 |
| 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 SILENOR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SILENOR | TABLET;ORAL | doxepin hydrochloride | 022036 | 2010-09-16 |
US Patents and Regulatory Information for SILENOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | RX | Yes | 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 SILENOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SILENOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2009537554 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007142810 | Start Trial |
| Canada | 2687118 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
