NORMODYNE Drug Patent Profile

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

Normodyne is a drug marketed by Schering and is included in two NDAs.

The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Normodyne

A generic version of NORMODYNE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3^rd, 1998.

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Summary for NORMODYNE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	4,247
DailyMed Link:	NORMODYNE at DailyMed

Drug patent expirations by year for NORMODYNE

Recent Clinical Trials for NORMODYNE

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

Sponsor	Phase
Nebraska Methodist Health System	Phase 4
Vanderbilt University	Phase 4
Brown (WIHRI)	Phase 4

See all NORMODYNE clinical trials

US Patents and Regulatory Information for NORMODYNE

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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	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 NORMODYNE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NORMODYNE

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

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Country	Patent Number	Title	Estimated Expiration
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES	⤷ Sign Up
Greece	34663	ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΠΑΡΑΓΩΓΩΝ ΦΕΝΥΛΑΜΙΝΟΕΘΑΝΟΛΗΣ.	⤷ Sign Up
Kenya	2539	PHENYLAMINOETHANOL DERIVATIVES	⤷ Sign Up
Netherlands	160805		⤷ Sign Up
Netherlands	7811843		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for NORMODYNE

Recent Clinical Trials for NORMODYNE

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