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Last Updated: May 12, 2024

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, Zydus Pharms, and Toprol, and is included in twenty-eight 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:	23
NDAs:	28
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	57
Patent Applications:	2,199
Formulation / Manufacturing:	see details
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
Cytokinetics	Phase 3
Yang I. Pachankis	Phase 4
Emory University	Phase 1/Phase 2

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
Mylan Pharms Inc	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	202033-002	Dec 15, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Visum Pharm	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	207206-001	Dec 19, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nesher Pharms	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	077176-001	May 14, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a 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 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	019962-003	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	⤷ Try a Trial	⤷ Try a Trial
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	⤷ Try a Trial	⤷ Try a Trial
>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
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)	⤷ Try a Trial
Australia	2015287299	Capsule dosage form of metoprolol succinate	⤷ Try a Trial
Mexico	2017000384	FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.)	⤷ Try a Trial
European Patent Office	3166599	FORME DOSIFIÉE DE CAPSULE DE SUCCINATE DE MÉTOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2016005934		⤷ Try a Trial
Brazil	112017000468	forma de dosagem de cápsula de liberação prolongada	⤷ Try a Trial
Japan	2017523164	コハク酸メトプロロールのカプセル剤形	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.