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Details for Patent: 6,080,759

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Patent 6,080,759 protects PAXIL and is included in one NDA. There has been one Paragraph IV challenge on Paxil.

Protection for PAXIL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-eight patent family members in fifty countries.

Summary for Patent: 6,080,759

Title: Paroxetine hydrochloride form A
Abstract:"Paroxetine hydrochloride (I) anhydrate free of bound propan-2-ol, and various forms thereof, are useful in the treatment of depression and other disorders for which administration of selective serotonin reuptake inhibitors are indicated."
Inventor(s): Ward; Neal (Crowborough, GB), Jacewicz; Victor Witold (Tunbridge Wells, GB)
Assignee: SmithKline Beecham Corporation (Philadelphia, PA)
Application Number:08/922,062
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 8th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 1998DISCNNo6,080,759*PED► subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 1998DISCNNo6,080,759*PED► subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-003Oct 9, 1998DISCNNo6,080,759*PED► subscribe
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Foreign Priority and PCT Information for Patent: 6,080,759

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9502297Feb 06, 1995
United Kingdom9503112Feb 17, 1995

Non-Orange Book Patents for Patent: 6,080,759

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
6,133,289 Paroxetine hydrochloride form A or C► subscribe
5,856,493 Process for making novel form of paroxeting hydrochloride anhydrate► subscribe
5,872,132 Form of paroxetine hydrochloride anhydrate► 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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International Patent Family for Patent: 6,080,759

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO)9600780► subscribe
Argentina001982► subscribe
Argentina036856► 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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