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Generated: July 21, 2017
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 Sun Pharm Inds, Par Pharm, Purepac Pharm, Teva Pharms, Pfizer, Wockhardt, Silarx, Pharm Assoc, Sandoz, Watson Labs, Mylan Pharms Inc, Quantum Pharmics, Pernix Theraps Llc, Actavis Elizabeth, Dava Pharms Inc, Amneal Pharms Co, New River, and Watson Labs Teva, and is included in sixty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 8 |
| Applicants: | 18 |
| NDAs: | 60 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 28 |
| Bulk Api Vendors: see list | 42 |
| Clinical Trials: see list | 2,258 |
| Patent Applications: see list | 908 |
| Therapeutic Class: | Dermatological Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | doxepin hydrochloride at DailyMed |
| Drug Class | Tricyclic Antidepressant |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 3MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 6MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 6MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Pharms Inc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 202337-001 | Jan 20, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Par Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071608-001 | Nov 9, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Par Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071697-001 | Nov 9, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Quantum Pharmics | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070932-001 | Sep 29, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Amneal Pharms Co | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482-005 | Jun 28, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | 5,948,438 | ► Subscribe | ||||||||||||||||||||||
Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 5,725,884 | ► Subscribe | ||||||||||||||||||||||
Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 5,866,166 | ► Subscribe | ||||||||||||||||||||||
Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 6,217,909 | ► Subscribe | ||||||||||||||||||||||
Pfizer | SINEQUAN | doxepin hydrochloride | CONCENTRATE;ORAL | 017516-001 | Approved Prior to Jan 1, 1982 | 3,420,851 | ► Subscribe | ||||||||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
| 9,498,462 | Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2009537554 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2007142810 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2008128115 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2721133 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2026792 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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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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