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: | 6,349 |
Drug Prices: | Drug price trends for METOLAZONE |
What excipients (inactive ingredients) are in METOLAZONE? | METOLAZONE excipients list |
DailyMed Link: | METOLAZONE at DailyMed |
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 |
Pharmacology for METOLAZONE
Drug Class | Thiazide-like Diuretic |
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for METOLAZONE
Anatomical Therapeutic Chemical (ATC) Classes for METOLAZONE
US Patents and Regulatory Information for METOLAZONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
I3 Pharms | ZAROXOLYN | metolazone | TABLET;ORAL | 017386-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ne Rx Pharma | METOLAZONE | metolazone | TABLET;ORAL | 216216-003 | Oct 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chemistry Hlth | METOLAZONE | metolazone | TABLET;ORAL | 218606-001 | Apr 17, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chemistry Hlth | METOLAZONE | metolazone | TABLET;ORAL | 218606-002 | Apr 17, 2024 | 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 METOLAZONE
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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