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DIOVAN HCT

NDA

HYDROCHLOROTHIAZIDE; VALSARTAN | N020818 | NOVARTIS PHARMACEUTICALS CORP

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS PHARMACEUTICALS CORPORATION v. LUPIN LTD. et al 1:2012cv04552 1 patentANDA 78946valsartan and hydrochlorothiazide	D.N.J.	2012-07-20	Terminated 2012-09-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Diovan HCT (2023)

Total Spending

$7.7M

Total Claims

8,763

Beneficiaries

1,990

Avg Cost/Unit

$12.38

Spending Trend

$11.5M(2019)→$10.6M(2020)→$8.8M(2021)→$7.8M(2022)→$7.7M(2023)

YoY Change:+13.4%

5yr CAGR:+4.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Aug 24, 2020	SUPPL -80	View Letter (PDF)
Jun 13, 2019	SUPPL -75	View Letter (PDF)
Sep 26, 2014	SUPPL -64	View Letter (PDF)
Jun 3, 2014	SUPPL -60	View Letter (PDF)
Mar 19, 2014	SUPPL -58	View Letter (PDF)
Mar 19, 2014	SUPPL -62	View Letter (PDF)
Oct 9, 2012	SUPPL -56	View Letter (PDF)
Jul 30, 2012	SUPPL -54	View Letter (PDF)
Feb 17, 2012	SUPPL -51	View Letter (PDF)
Jan 23, 2012	SUPPL -53	View Letter (PDF)
Dec 14, 2011	SUPPL -46	View Letter (PDF)
Dec 14, 2011	SUPPL -49	View Letter (PDF)
Jun 9, 2011	SUPPL -47	View Letter (PDF)
Apr 23, 2010	SUPPL -43	View Letter (PDF)
Aug 5, 2008	SUPPL -36	View Letter (PDF)
Sep 11, 2007	SUPPL -35	View Letter (PDF)
Dec 4, 2006	SUPPL -32	View Letter (PDF)
May 2, 2006	SUPPL -27	View Letter (PDF)
Jul 15, 2005	SUPPL -24	View Letter (PDF)
Jun 2, 2004	SUPPL -16	View Letter (PDF)
Jun 2, 2004	ORIG -1	View Letter (PDF)
Jan 17, 2002	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 12.5MG;80MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 6, 1998

No patent or exclusivity listings for this strength.

#002 — 12.5MG;160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 6, 1998

#003 — 25MG;160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 17, 2002

#004 — 12.5MG;320MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 28, 2006

#005 — 25MG;320MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 28, 2006