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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Novartis
Federal Trade Commission
Healthtrust
Argus Health
Accenture
Baxter
Cipla
Chubb
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Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for Patent: 9,000,038

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Which drugs does patent 9,000,038 protect, and when does it expire?


Patent 9,000,038 protects CONCERTA and is included in one NDA. There have been two Paragraph IV challenges on Concerta.

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

This patent has sixty-eight patent family members in seventeen countries.

Summary for Patent: 9,000,038

Title:Methods and devices for providing prolonged drug therapy
Abstract: Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
Inventor(s): Lam; Andrew C. (Palo Alto, CA), Shivanand; Padmaja (Palo Alto, CA), Ayer; Atul D (Palo Alto, CA), Hatamkhany; Zahedeh (Palo Alto, CA), Weyers; Richard G (Palo Alto, CA), Gupta; Suneel K. (Palo Alto, CA), Guinta; Diane R (Palo Alto, CA), Christopher; Carol A. (Palo Alto, CA), Saks; Samuel R. (Palo Alto, CA), Hamel; Lawrence G. (Palo Alto, CA), Wright; Jeri D. (Palo Alto, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:13/800,869
Patent Claim Types:
see list of patent claims
Use; Dosage form; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002ABRXYesNo► Subscribe► SubscribeY
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 9,000,038

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
7,521,067Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
2,015,125,493► Subscribe
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
8,629,179Methods and devices for providing prolonged drug therapy► Subscribe
9,029,416Methods and devices for providing prolonged drug therapy► Subscribe
6,930,129 Methods and devices for providing prolonged drug therapy► Subscribe
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
8,163,798Methods and devices for providing prolonged drug therapy► Subscribe
9,144,549Methods and devices for providing prolonged drug therapy► Subscribe
6,034,101 United States Patent: 6034101   ( 1► 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: 9,000,038

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria277594► Subscribe
Austria321529► Subscribe
Austria325606► Subscribe
Australia4319799► Subscribe
Australia4801497► Subscribe
Australia5267698► Subscribe
Australia9639101► Subscribe
Canada2264852► Subscribe
Canada2265668► Subscribe
Canada2333688► 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:

US Army
US Department of Justice
McKinsey
Citi
Deloitte
Merck
Harvard Business School
Argus Health
Boehringer Ingelheim
Farmers Insurance

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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