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Serving leading biopharmaceutical companies globally:

AstraZeneca
Daiichi Sankyo
Cipla
Deloitte
Teva
Fuji
UBS
US Army
Cerilliant
Baxter

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,778,390

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Which drugs does patent 8,778,390 protect, and when does it expire?

Patent 8,778,390 protects QUILLIVANT XR and is included in one NDA.

This patent has six patent family members in five countries.
Summary for Patent: 8,778,390
Title:Orally effective methylphenidate extended release powder and aqueous suspension product
Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Inventor(s): Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Edison, NJ)
Assignee: TRIS Pharma, Inc. (Monmouth Junction, NJ)
Application Number:14/016,384
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation; Use; Delivery;

Drugs Protected by US Patent 8,778,390

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,778,390

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
8,287,903 Orally effective methylphenidate extended release powder and aqueous suspension product ➤ Try a Free Trial
8,956,649 Orally effective methylphenidate extended release powder and aqueous suspension product ➤ Try a Free Trial
9,040,083 Orally effective methylphenidate extended release powder and aqueous suspension product ➤ Try a Free Trial
8,465,765 Orally effective methylphenidate extended release powder and aqueous suspension product ➤ Try a Free Trial
8,563,033 Orally effective methylphenidate extended release powder and aqueous suspension product ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,778,390

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011359405 ➤ Try a Free Trial
Australia 2017202955 ➤ Try a Free Trial
Canada 2825991 ➤ Try a Free Trial
European Patent Office 2675438 ➤ Try a Free Trial
Israel 227734 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 2012112140 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
UBS
Mallinckrodt
Baxter
Boehringer Ingelheim
Queensland Health
Cantor Fitzgerald
Medtronic

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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