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Last Updated: November 2, 2024

NYSTATIN - Generic Drug Details

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

Nystatin is the generic ingredient in seventeen branded drugs marketed by Bayer Pharms, Delcor Asset Corp, Alpharma Us Pharms, Lederle, Actavis Mid Atlantic, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Strides Pharma, Taro, Torrent, Lyne, Zydus Lifesciences, Barlan, Paddock Llc, Adrastea Pharma, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Warner Chilcott, Chartwell Molecules, Fougera Pharms Inc, G And W Labs Inc, Genus, Leading, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, Savage Labs, Chartwell Rx, Heritage Pharms, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Holland Rantos, Fougera, Odyssey Pharms, Mylan, Alembic, Amneal, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Pai Holdings Pharm, and Rising, and is included in one hundred and twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nystatin. Forty-one suppliers are listed for this compound.

Summary for NYSTATIN

US Patents:	0
Tradenames:	17
Applicants:	59
NDAs:	121
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	38
Patent Applications:	7,265
Drug Prices:	Drug price trends for NYSTATIN
Drug Sales Revenues:	Drug sales revenues for NYSTATIN
What excipients (inactive ingredients) are in NYSTATIN?	NYSTATIN excipients list
DailyMed Link:	NYSTATIN at DailyMed

Drug Prices for NYSTATIN

See drug prices for NYSTATIN

Drug Sales Revenue Trends for NYSTATIN

See drug sales revenues for NYSTATIN

Recent Clinical Trials for NYSTATIN

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

Sponsor	Phase
University of Santiago de Compostela	N/A
University of Rochester	Phase 1
Minia University	Early Phase 1

See all NYSTATIN clinical trials

Pharmacology for NYSTATIN

Drug Class	Polyene Antifungal

Medical Subject Heading (MeSH) Categories for NYSTATIN

Anti-Bacterial Agents
Antifungal Agents
Ionophores

US Patents and Regulatory Information for NYSTATIN

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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
Sandoz	NYSTATIN	nystatin	TABLET;VAGINAL	061965-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	NYSTATIN	nystatin	CREAM;TOPICAL	212557-001	Jul 24, 2019	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Delcor Asset Corp	MYCOSTATIN	nystatin	OINTMENT;TOPICAL	060571-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	NYSTATIN	nystatin	POWDER;TOPICAL	065203-001	Jul 15, 2004	AT	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nesher Pharms	NYSTATIN	nystatin	POWDER;TOPICAL	065321-001	Aug 18, 2006		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

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