Metoprolol succinate - Generic Drug Details

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What are the generic drug sources for metoprolol succinate and what is the scope of freedom to operate?

Metoprolol succinate is the generic ingredient in three branded drugs marketed by Spil, Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, and Toprol, and is included in twenty-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Metoprolol succinate has eight patent family members in seven countries.

There are thirty drug master file entries for metoprolol succinate. Forty-nine suppliers are listed for this compound.

Summary for metoprolol succinate

International Patents:	8
US Patents:	2
Tradenames:	3
Applicants:	24
NDAs:	29
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	58
Patent Applications:	2,197
Drug Prices:	Drug price trends for metoprolol succinate
Drug Sales Revenues:	Drug sales revenues for metoprolol succinate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metoprolol succinate
What excipients (inactive ingredients) are in metoprolol succinate?	metoprolol succinate excipients list
DailyMed Link:	metoprolol succinate at DailyMed

See drug prices for metoprolol succinate

Drug Sales Revenue Trends for metoprolol succinate

See drug sales revenues for metoprolol succinate

Recent Clinical Trials for metoprolol succinate

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
Cytokinetics	Phase 3
Yang I. Pachankis	Phase 4

See all metoprolol succinate clinical trials

Pharmacology for metoprolol succinate

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for metoprolol succinate

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for metoprolol succinate

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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
Accord Hlthcare	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	215637-002	Oct 18, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Visum Pharm	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	207206-003	Dec 19, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	209272-002	Aug 15, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	203894-002	Mar 23, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	209272-001	Aug 15, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	204106-001	Feb 6, 2018	AB	RX	No	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 metoprolol succinate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for metoprolol succinate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016005934		⤷ Sign Up
Mexico	2017000384	FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.)	⤷ Sign Up
Japan	6626492		⤷ Sign Up
Brazil	112017000468	forma de dosagem de cápsula de liberação prolongada	⤷ Sign Up
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)	⤷ Sign Up
Australia	2015287299	Capsule dosage form of metoprolol succinate	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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