Metoprolol tartrate - Generic Drug Details

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

Metoprolol tartrate is the generic ingredient in two branded drugs marketed by Novartis, Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Sandoz, Steriscience, Watson Labs, Validus Pharms, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Norvium Bioscience, Purepac Pharm, Renata, Rubicon, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Youngtech Pharms Inc, and Zydus Pharms, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for metoprolol tartrate. Fifty-five suppliers are listed for this compound.

Summary for metoprolol tartrate

US Patents:	0
Tradenames:	2
Applicants:	30
NDAs:	35
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	25
Patent Applications:	2,392
Drug Prices:	Drug price trends for metoprolol tartrate
Drug Sales Revenues:	Drug sales revenues for metoprolol tartrate
What excipients (inactive ingredients) are in metoprolol tartrate?	metoprolol tartrate excipients list
DailyMed Link:	metoprolol tartrate at DailyMed

See drug prices for metoprolol tartrate

Drug Sales Revenue Trends for metoprolol tartrate

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Recent Clinical Trials for metoprolol tartrate

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

Sponsor	Phase
Instituto de Salud Carlos III	Phase 3
European Commission	Phase 3
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 3

See all metoprolol tartrate clinical trials

Pharmacology for metoprolol tartrate

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

Anatomical Therapeutic Chemical (ATC) Classes for metoprolol tartrate

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

US Patents and Regulatory Information for metoprolol tartrate

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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
Watson Labs	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	074032-001	Dec 21, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipca Labs Ltd	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	078459-003	Jun 17, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	076704-005	Mar 18, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	077739-004	Dec 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	073666-002	Dec 21, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	200981-003	Oct 28, 2014	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 tartrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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