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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tenormin (2023)

Total Spending

$3.5M

Total Claims

2,934

Beneficiaries

678

Avg Cost/Unit

$13.27

Spending Trend

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

YoY Change:+0.3%

5yr CAGR:+1.8%

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

API Supply Chain6 active DMFs27 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDATENOLOL

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

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