NORMOZIDE Drug Patent Profile

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Which patents cover Normozide, and when can generic versions of Normozide launch?

Normozide is a drug marketed by Schering and is included in one NDA.

The generic ingredient in NORMOZIDE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

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Summary for NORMOZIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
DailyMed Link:	NORMOZIDE at DailyMed

Drug patent expirations by year for NORMOZIDE

US Patents and Regulatory Information for NORMOZIDE

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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
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987		DISCN	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 NORMOZIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987	4,066,755	⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987	4,066,755	⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987	4,012,444	⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987	4,012,444	⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987	4,012,444	⤷ Start Trial
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987	4,012,444	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NORMOZIDE

See the table below for patents covering NORMOZIDE around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	280996		⤷ Start Trial
Austria	300763		⤷ Start Trial
Belgium	704037		⤷ Start Trial
Belgium	752892		⤷ Start Trial
Canada	932734	PHENYLAMINOETHANOL DERIVATIVES	⤷ Start Trial
Canada	983524	PHENYLAMINOETHANOL DERIVATIVES	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NORMOZIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland	⤷ Start Trial	PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	SPC/GB02/037	United Kingdom	⤷ Start Trial	PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands	⤷ Start Trial	PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0503785	CA 2011 00026	Denmark	⤷ Start Trial	PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	SPC/GB99/008	United Kingdom	⤷ Start Trial	PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0454511	99C0009	Belgium	⤷ Start Trial	PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for NORMOZIDE

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