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Generated: November 25, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,419,958

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Which drugs does patent 6,419,958 protect, and when does it expire?


Patent 6,419,958 protects VENLAFAXINE HYDROCHLORIDE and EFFEXOR XR and is included in two NDAs. There has been one Paragraph IV challenge on Effexor XR.

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

This patent has eighty-seven patent family members in forty-four countries.

Summary for Patent: 6,419,958

Title: Extended release formulation of venlafaxine hydrochloride
Abstract:This invention relates to a 24 hour extended release dosage formulation and unit dosage form thereof of venlafaxine hydrochloride, an antidepressant, which provides better control of blood plasma levels than conventional tablet formulations which must be administered two or more times a day and further provides a lower incidence of nausea and vomiting than the conventional tablets. More particularly, the invention comprises an extended release formulation of venlafaxine hydrochloride comprising a therapeutically effective amount of venlafaxine hydrochloride in spheroids comprised of venlafaxine hydrochloride, microcrystalline cellulose and, optionally, hydroxypropylmethylcellulose coated with a mixture of ethyl cellulose and hydroxypropylmethylcellulose.
Inventor(s): Sherman; Deborah M. (Plattsburgh, NY), Clark; John C. (Peru, NY), Lamer; John U. (St. Albans, VT), White; Steven A. (Champlain, NY)
Assignee: Wyeth (Madison, NJ)
Application Number:09/884,412
Patent Claim Types:
see list of patent claims
Use; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-001May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF SOCIAL ANXIETY DISORDER
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-001May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-002May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-002May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF SOCIAL ANXIETY DISORDER
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-003May 20, 2008ABRXYesYes► Subscribe► Subscribe TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-003May 20, 2008ABRXYesYes► Subscribe► Subscribe TREATMENT OF SOCIAL ANXIETY DISORDER
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-004May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-004May 20, 2008ABRXYesNo► Subscribe► Subscribe TREATMENT OF SOCIAL ANXIETY DISORDER
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-001Oct 20, 1997ABRXYesNo► Subscribe► SubscribeY
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 1997ABRXYesNo► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,419,958

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
6,274,171 Extended release formulation of venlafaxine hydrochloride► Subscribe
6,403,120 Extended release formulation of venlafaxine hydrochloride► 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: 6,419,958

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine77145► Subscribe
Taiwan555568► Subscribe
Taiwan493993► Subscribe
Turkey200001232► Subscribe
Turkey9700190► Subscribe
El Salvador1998000131► Subscribe
El Salvador1997000015► Subscribe
Slovakia6472000► Subscribe
Slovakia281530► Subscribe
Slovakia30197► 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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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Federal Trade Commission
Novartis
Johnson and Johnson
Farmers Insurance
Moodys
Daiichi Sankyo
Julphar
Accenture

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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