Viewing data from:

TENORETIC 100

NDA

ATENOLOL; CHLORTHALIDONE | N018760 | TWI PHARMACEUTICALS INC

2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Tenoretic 50 (2023)

Total Spending

$107K

Total Claims

150

Beneficiaries

Avg Cost/Unit

$12.23

Spending Trend

$198K(2019)→$166K(2020)→$131K(2021)→$128K(2022)→$107K(2023)

YoY Change:+0.4%

5yr CAGR:+1.6%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2023	SUPPL -44	View Letter (PDF)
Nov 1, 2012	SUPPL -29	View Letter (PDF)
Aug 18, 2011	SUPPL -28	View Letter (PDF)
Oct 30, 2008	SUPPL -27	View Letter (PDF)
Feb 11, 2005	SUPPL -26	View Letter (PDF)
Dec 2, 2003	SUPPL -25	View Letter (PDF)
Jan 31, 2003	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG;25MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 8, 1984

No patent or exclusivity listings for this strength.

#002 — 50MG;25MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 8, 1984