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Paroxetine hydrochloride - Generic Drug Details
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This ingredient has three hundred and fifty-six patent family members in fifty-seven countries.
There are twenty-nine drug master file entries for paroxetine hydrochloride. Fifty-one suppliers are listed for this compound.
Summary for Generic Name: paroxetine hydrochloride
| Tradenames: | 4 |
| Patents: | 10 |
| Applicants: | 16 |
| NDAs: | 21 |
| Drug Master File Entries: see list | 29 |
| Suppliers / Packaging: see list | 51 |
| Therapeutic Class: | Antidepressants Anxiolytics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: paroxetine hydrochloride
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Clinical Trials for: paroxetine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Technologies | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | RX | Yes | 5,900,423*PED | Nov 19, 2015 | ||||||||||||||||||||
Sandoz | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075566-003 | Mar 8, 2004 | DISCN | No | ||||||||||||||||||||||
Roxane | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078026-001 | Jun 29, 2007 | DISCN | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: paroxetine hydrochloride
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Technologies | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | 5,422,123*PED | <disabled> | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | 6,080,759*PED | <disabled> | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 6,113,944*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: paroxetine hydrochloride
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,856,493 | Process for making novel form of paroxeting hydrochloride anhydrate | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: paroxetine hydrochloride
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Morocco | 23942 | <disabled in preview> | |||||||||||||||||||||||||||
| Bulgaria | 100333 | <disabled in preview> | |||||||||||||||||||||||||||
| Austria | 3185 | <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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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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