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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					Y
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No					Y
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No					Y
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No					Y
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,475,839

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