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Last Updated: February 17, 2020

DrugPatentWatch Database Preview

Details for Patent: 8,475,839


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Which drugs does patent 8,475,839 protect, and when does it expire?

Patent 8,475,839 protects EXFORGE HCT and is included in one NDA.

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

This patent has twenty-five patent family members in twenty-two countries.

Summary for Patent: 8,475,839
Title:Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Abstract: Monolayer, bilayer and trilayer solid dosage forms of a combination of valsartan, amlodipine and hydrochlorothiazide are made.
Inventor(s): Cao; Yu (Parsippany, NJ), Joshi; Yatindra (Princeton, NJ), Li; Ping (Basking Ridge, NJ), Pudipeddi; Madhusudhan (Mumbai, IN), Royce; Alan E (Saylorsburg, PA), Wagner; Robert F (Hillsborough, NJ), Zhu; Jiahao (Whippany, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:13/342,533
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition;

Drugs Protected by US Patent 8,475,839

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,475,839

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 061627   Start Trial
Australia 2007265138   Start Trial
Brazil PI0713785   Start Trial
Canada 2654986   Start Trial
Chile 2007001870   Start Trial
China 101478956   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Colorcon
Dow
AstraZeneca
McKesson

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