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Last Updated: February 19, 2020

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NILSTAT Drug Profile


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Which patents cover Nilstat, and when can generic versions of Nilstat launch?

Nilstat is a drug marketed by Lederle, Dava Pharms Inc, and Glenmark Generics. and is included in six NDAs.

The generic ingredient in NILSTAT is nystatin. There are eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the nystatin profile page.

US ANDA Litigation and Generic Entry Outlook for Nilstat

A generic version of NILSTAT was approved as nystatin by FOUGERA PHARMS on September 23rd, 1982.

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Summary for NILSTAT
Drug patent expirations by year for NILSTAT
Synonyms for NILSTAT
(1S,15S,16R,17R,18S,19E,21E,25E,27E,29E,31E)-33-(((2S,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-d
(Liposomal Nystatin)Nyotrantrade mark
1400-61-9
AC1O5FWI
AI3-26526
AKOS016339654
AV & NYS
Barstatin 100
Biofanal
C47H75NO17
Candex Lotion
Candio-hermal
Caswell No. 607B
CHEBI:473992
Comycin
Diastatin
EINECS 215-749-0
EPA Pesticide Chemical Code 202800
Herniocid
HSDB 3138
ioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic acid
KS-1373
LS-97612
MolPort-003-983-447
Moronal
Moronal (antibiotic)
Myconystatin
Mycostatin
Mycostatin 20
Mycostatin Pastilles
Mykinac
Mykostatyna
Nistatin
Nistatina [INN-Spanish]
NSC 150817
Nyamyc
Nyotran
Nystaform
Nystan
nystatin
Nystatin [INN:BAN:JAN]
Nystatin [USP:INN:BAN:JAN]
Nystatin + Aloe Vera Extract
Nystatin A
Nystatin A1
Nystatin A1 A2 A3 complex
Nystatin A1, A2, A3 complex
Nystatin antibiotic complex
Nystatin G
Nystatin LF (liposome)
Nystatine
Nystatine [INN-French]
Nystatinum
Nystatinum [INN-Latin]
Nystatyna
Nystatyna [Polish]
Nystavescent
Nystex
Nystop
O-V Statin
SCHEMBL284974
Stamycin
Terrastatin
Zydin E

US Patents and Regulatory Information for NILSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle NILSTAT nystatin CREAM;TOPICAL 061445-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics NILSTAT nystatin SUSPENSION;ORAL 050299-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Lederle NILSTAT nystatin OINTMENT;TOPICAL 061444-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Dava Pharms Inc NILSTAT nystatin POWDER;ORAL 050576-001 Dec 22, 1983 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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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