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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army
Dow
UBS
Julphar
QuintilesIMS
Moodys
Chubb
Cerilliant
AstraZeneca

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,580,302

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Which drugs does patent 8,580,302 protect, and when does it expire?

Patent 8,580,302 protects ASACOL HD and is included in one NDA.

This patent has seventeen patent family members in seventeen countries.
Summary for Patent: 8,580,302
Title:Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Abstract: The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
Inventor(s): Dittmar; Gregory Paul (Norwich, NY), Amante; Joseph Michael (Norwich, NY), Cronk; Tony Ryan (Mishawaka, IN), Newby; Daniel Gary (South New Berlin, NY)
Assignee: Warner Chilcott Company, LLC (Fajardo, PR)
Application Number:11/070,995
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use; Delivery;

Drugs Protected by US Patent 8,580,302

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
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 8,580,302

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
6,893,662 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures ➤ Subscribe
9,089,492 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,580,302

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
New Zealand 532564 ➤ Subscribe
Japan 4999037 ➤ Subscribe
Mexico PA04004747 ➤ Subscribe
Japan 2005510539 ➤ Subscribe
Israel 161628 ➤ Subscribe
Hungary 0402230 ➤ Subscribe
Spain 2301575 ➤ Subscribe
European Patent Office 1453487 ➤ Subscribe
Denmark 1453487 ➤ Subscribe
Germany 60133319 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Fuji
Cipla
Mallinckrodt
Moodys
QuintilesIMS
Julphar
Healthtrust
Queensland Health
Colorcon

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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