Viewing data from:

TENORMIN

NDA

ATENOLOL | N018240 | TWI PHARMACEUTICALS INC

3 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

87 trials from ClinicalTrials.gov — 1 recruiting, 62 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV NCT02560805	Phase 2	Recruiting	Emory University	134	2015-10 → 2027-03-30
Reducing Total Cardiovascular Risk in an Urban Community NCT00241904	Phase 4	Completed	Johns Hopkins University	525	2006-05 → 2010-05
Trial of Antihypertensive Intervention Management NCT00000513	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1984-04 → 1994-11
Health Assessment Study (0954-946)NCT00541684	Phase 3	Completed	Organon and Co	143	2001-07-11 → 2003-01-23
Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure NCT00669279	Phase 4	Completed	University of Florida	41	2008-04 → 2010-07
Vascular Improvement With Olmesartan Medoxomil Study NCT00772499	Phase 4	Completed	Daiichi Sankyo	100	2002-11 → 2005-07
Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation NCT01719367	N/A	Completed	Vanderbilt University Medical Center	38	2013-01 → 2016-09
To Demonstrate the Relative Bioavailability of Atenolol Tablets NCT00913965	Phase 1	Completed	Sandoz	24	1989-07 → 1989-08
Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.NCT00171756	Phase 4	Completed	Novartis	92	2004-06 → 2006-03
Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm NCT01022463	Phase 3	Completed	Govind Ballabh Pant Hospital	50	2009-11 → 2010-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$12.80

per ea

Lowest NADAC/Unit

$12.80

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24979024507TENORMIN 50 MG TABLET	$12.80	EA	Brand	$0.0247	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$775.48

Highest Price

$837.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52427-0429-90TENORMIN 25MG TAB	$797.65	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
52427-0431-90TENORMIN 100MG TAB	$775.48	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
52427-0430-90TENORMIN 50MG TAB	$837.10	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
24979-0245-07TENORMIN 50MG TAB	$837.10	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
24979-0244-07TENORMIN 25MG TAB	$797.65	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
24979-0246-07TENORMIN 100MG TAB	$775.48	FSS	Upsher-Smith Laboratories, LLC	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Tenormin (2024)

Total Spending

$3.1M

Total Claims

2,584

Beneficiaries

606

Avg Cost/Unit

$12.57

Spending Trend

$5.6M(2019)→$4.9M(2020)→$4.4M(2021)→$4.1M(2022)→$3.5M(2023)→$3.1M(2024)

YoY Change:-5.3%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs28 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVATENOLOL

DMF 62131986

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLATENOLOL

DMF 69791987

ZYDUS LIFESCIENCES LTDATENOLOL USP

DMF 142101999

IPCA LABORATORIES LTDATENOLOL USP

DMF 150372000

UNIQUE CHEMICALSATENOLOL USP

DMF 240242010

KOPRAN RESEARCH LABORATORIES LTDATENOLOL USP

DMF 330072018

ERREGIERRE SPAInactiveATENOLOL

DMF 63251986

ASTRAZENECA PHARMACEUTICALS LPInactiveATENOLOL

DMF 69051987

SIBEFAT SPAInactiveATENOLOL

DMF 69211987

ASTRAZENECA PHARMACEUTICALS LPInactiveATENOLOL ACETATE

DMF 71011987

BLASCHIM SPAInactiveATENOLOL

DMF 71331987

PRODESFARMA QUIMICA SLInactiveATENOLOL

DMF 71751987

IMPERIAL CHEMICAL INDUSTRIES PLCInactiveATENOLOL BULK DRUG

DMF 72001987

AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPAInactiveATENOLOL

DMF 72651987

SINTENOVA SAInactiveATENOLOL

DMF 75861988

FRANCIS SPAInactiveATENOLOL

DMF 75911988

IPCA LABORATORIES PRIVATE LTDInactiveATENOLOL

DMF 78211988

COSMA SPAInactiveATENOLOL

DMF 79331989

FREEDOM CHEMICAL DIAMALT GMBHInactiveATENOLOL

DMF 80151989

SHANGHAI NO 2 PHARMACEUTICAL FACTORYInactiveATENOLOL USP

DMF 85981990

ARCHIMICA SPAInactiveATENOLOL

DMF 88341990

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveATENOLOL

DMF 89651991

PERIMMUNE INCInactiveATENOLOL

DMF 91961991

SYNCHEM CHEMICALS PRIVATE LTDInactiveATENOLOL

DMF 111341994

IPR PHARMACEUTICALS INCInactiveATENOLOL BULK DRUG

DMF 121491996

TIANJIN CENTRAL PHARMACEUTICAL CO LTDInactiveATENOLOL USP

DMF 178682004

PHARMAZELL INDIA PRIVATE LTDInactiveATENOLOL USP

DMF 196722006

WANBURY LTDInactiveATENOLOL

DMF 202682007

MYLAN LABORATORIES LTDInactiveATENOLOL USP

DMF 203992007

SYN-TECH CHEM AND PHARM CO LTDInactiveATENOLOL USP

DMF 216172008

AMRI INDIA PVT LTDInactiveATENOLOL, USP DRUG SUBSTANCE

DMF 216592008

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveATENOLOL

DMF 233272009

KOPRAN LTDInactiveATENOLOL

DMF 250102011

AMRI INDIA PVT LTDInactiveATENOLOL USP DRUG SUBSTANCE

DMF 299712015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2023	SUPPL -47	View Letter (PDF)
Nov 5, 2012	SUPPL -32	View Letter (PDF)
Aug 18, 2011	SUPPL -31	View Letter (PDF)
May 5, 2008	SUPPL -30	View Letter (PDF)
Feb 11, 2005	SUPPL -29	View Letter (PDF)
Nov 13, 2003	SUPPL -28	View Letter (PDF)
Jan 9, 2003	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 25MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 9, 1990