PAXIL CR Drug Patent Profile
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When do Paxil Cr patents expire, and what generic alternatives are available?
Paxil Cr is a drug marketed by Apotex and is included in one NDA.
The generic ingredient in PAXIL CR is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paxil Cr
A generic version of PAXIL CR was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.
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Summary for PAXIL CR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Patent Applications: | 3,903 |
| Drug Prices: | Drug price information for PAXIL CR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PAXIL CR |
| DailyMed Link: | PAXIL CR at DailyMed |
Pharmacology for PAXIL CR
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Paragraph IV (Patent) Challenges for PAXIL CR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PAXIL CR | Extended-release Tablets | paroxetine hydrochloride | 37.5 mg | 020936 | 1 | 2009-05-19 |
| PAXIL CR | Extended-release Tablets | paroxetine hydrochloride | 25 mg | 020936 | 1 | 2005-09-09 |
US Patents and Regulatory Information for PAXIL CR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 CR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PAXIL CR
See the table below for patents covering PAXIL CR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1010494 | ⤷ Sign Up | |
| Latvia | 11618 | NOVEL COMPOUNDS | ⤷ Sign Up |
| Luxembourg | 90483 | ⤷ Sign Up | |
| Slovenia | 1089996 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9624595 | ⤷ Sign Up | |
| Germany | 19958228 | ⤷ Sign Up | |
| United Kingdom | 9605828 | ⤷ Sign Up | |
| >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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