METOLAZONE - Generic Drug Details

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What are the generic sources for metolazone and what is the scope of freedom to operate?

Metolazone is the generic ingredient in four branded drugs marketed by Gd Searle Llc, Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, Watson Labs, Chartwell Molecular, and I3 Pharms, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for metolazone. Eighteen suppliers are listed for this compound.

Summary for METOLAZONE

US Patents:	0
Tradenames:	4
Applicants:	15
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	24
Patent Applications:	6,347
Drug Prices:	Drug price trends for METOLAZONE
What excipients (inactive ingredients) are in METOLAZONE?	METOLAZONE excipients list
DailyMed Link:	METOLAZONE at DailyMed

See drug prices for METOLAZONE

Drug Sales Revenue Trends for METOLAZONE

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Recent Clinical Trials for METOLAZONE

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

Sponsor	Phase
Johannes Grand	Phase 4
Stadtspital Zürich	Phase 4
Ospedale Regionale di Lugano	Phase 4

See all METOLAZONE clinical trials

Pharmacology for METOLAZONE

Drug Class	Thiazide-like Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for METOLAZONE

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METOLAZONE

C03BA	Sulfonamides, plain
C03B	LOW-CEILING DIURETICS, EXCL. THIAZIDES
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for METOLAZONE

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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
Bayshore Pharms Llc	METOLAZONE	metolazone	TABLET;ORAL	214799-001	Mar 30, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	METOLAZONE	metolazone	TABLET;ORAL	075543-003	Dec 24, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251-003	Dec 2, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	METOLAZONE	metolazone	TABLET;ORAL	075543-002	Mar 1, 2004		DISCN	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 METOLAZONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chartwell Molecular	MYKROX	metolazone	TABLET;ORAL	019532-001	Oct 30, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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