Atenolol; chlorthalidone - Generic Drug Details

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What are the generic drug sources for atenolol; chlorthalidone and what is the scope of patent protection?

Atenolol; chlorthalidone is the generic ingredient in three branded drugs marketed by Alvogen, Mylan, Nostrum Labs, Pliva, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-four drug master file entries for atenolol; chlorthalidone. Eleven suppliers are listed for this compound.

Summary for atenolol; chlorthalidone

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	34
Suppliers / Packagers:	11
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atenolol; chlorthalidone
DailyMed Link:	atenolol; chlorthalidone at DailyMed

Recent Clinical Trials for atenolol; chlorthalidone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Agenzia Italiana del Farmaco	Phase 4
Federico II University	Phase 4
VA Office of Research and Development	N/A

See all atenolol; chlorthalidone clinical trials

Pharmacology for atenolol; chlorthalidone

Drug Class	beta-Adrenergic Blocker Thiazide-like Diuretic
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for ATENOLOL; CHLORTHALIDONE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TENORETIC 100	TABLET;ORAL	atenolol; chlorthalidone	018760
TENORETIC 50	TABLET;ORAL	atenolol; chlorthalidone	018760

US Patents and Regulatory Information for atenolol; chlorthalidone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nostrum Labs	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074404-002	May 14, 1998		DISCN	No	No	Start Trial	Start Trial				Start Trial
Alvogen	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	072302-001	May 31, 1990	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Sun Pharm Industries	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	073582-002	Apr 29, 1993	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074203-001	Oct 31, 1993	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for atenolol; chlorthalidone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	Start Trial	Start Trial
Alvogen	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	Start Trial	Start Trial
Alvogen	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	Start Trial	Start Trial
Alvogen	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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