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Doxepin hydrochloride - Generic Drug Details
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This ingredient has twelve patent family members in four countries.
There are seven drug master file entries for doxepin hydrochloride. Twenty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for Generic Name: doxepin hydrochloride
| Tradenames: | 4 |
| Patents: | 4 |
| Applicants: | 17 |
| NDAs: | 59 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packaging: see list | 27 |
| Therapeutic Class: | Antidepressants Anxiolytics Dermatological Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: doxepin hydrochloride
| Drug Class | Tricyclic Antidepressant |
Tentative approvals for DOXEPIN HYDROCHLORIDE
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 3MG |
| <disabled> | <disabled> | TABLET; ORAL | 6MG |
| <disabled> | <disabled> | TABLET; ORAL | 3MG |
Clinical Trials for: doxepin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | RX | Yes | 8,513,299 | Sep 7, 2030 | ||||||||||||||||||||
Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-001 | Approved Prior to Jan 1, 1982 | DISCN | No | ||||||||||||||||||||||
Pharm Assoc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CONCENTRATE;ORAL | 075924-001 | Jan 15, 2004 | DISCN | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: doxepin hydrochloride
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-006 | Approved Prior to Jan 1, 1982 | 3,420,851 | <disabled> | ||||||||||||||||||||||
Pfizer | SINEQUAN | doxepin hydrochloride | CAPSULE;ORAL | 016798-005 | Approved Prior to Jan 1, 1982 | 3,420,851 | <disabled> | ||||||||||||||||||||||
Pernix Theraps Llc | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 5,866,166 | <disabled> | ||||||||||||||||||||||
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International Patent Family for Ingredient: doxepin hydrochloride
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2013237694 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2016041757 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2693992 | <disabled in preview> | |||||||||||||||||||||||||||
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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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