PAXIL Drug Patent Profile
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When do Paxil patents expire, and what generic alternatives are available?
Paxil is a drug marketed by Apotex and is included in four NDAs.
The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paxil
A generic version of PAXIL was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.
Summary for PAXIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Patent Applications: | 1,956 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PAXIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PAXIL |
| What excipients (inactive ingredients) are in PAXIL? | PAXIL excipients list |
| DailyMed Link: | PAXIL at DailyMed |
Pharmacology for PAXIL
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PAXIL
US Patents and Regulatory Information for PAXIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-002 | Dec 29, 1992 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-002 | Oct 9, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 PAXIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PAXIL
See the table below for patents covering PAXIL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 345365 | ⤷ Try a Trial | |
| Morocco | 23441 | ⤷ Try a Trial | |
| Australia | 697982 | ⤷ Try a Trial | |
| African Regional IP Organization (ARIPO) | 9600780 | ⤷ Try a Trial | |
| Ireland | 991107 | ⤷ Try a Trial | |
| Germany | 19918588 | ⤷ Try a Trial | |
| African Regional IP Organization (ARIPO) | 9400704 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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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