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Last Updated: December 12, 2019

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FLUNISOLIDE Drug Profile

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When do Flunisolide patents expire, and when can generic versions of Flunisolide launch?

Flunisolide is a drug marketed by Apotex Inc, Bausch And Lomb, and Hi Tech Pharma Co. and is included in three NDAs.

The generic ingredient in FLUNISOLIDE is flunisolide. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the flunisolide profile page.

US ANDA Litigation and Generic Entry Outlook for Flunisolide

A generic version of FLUNISOLIDE was launched as flunisolide by BAUSCH AND LOMB on December 12th, 2019.

Drug patent expirations by year for FLUNISOLIDE
Drug Prices for FLUNISOLIDE

See drug prices for FLUNISOLIDE

Drug Sales Revenue Trends for FLUNISOLIDE

See drug sales revenues for FLUNISOLIDE

Recent Clinical Trials for FLUNISOLIDE

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

SponsorPhase
University of LouisvilleN/A
Meda PharmaceuticalsN/A
GlaxoSmithKlinePhase 3

See all FLUNISOLIDE clinical trials

Recent Litigation for FLUNISOLIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.2006-05-02

See all FLUNISOLIDE litigation

Pharmacology for FLUNISOLIDE
Synonyms for FLUNISOLIDE
(1S,2S,4R,8S,9S,11S,12S,13R,19S)-19-fluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.0;{2,9}.0;{4,8}.0;{13,18}]icosa-14,17-dien-16-one
32277-EP2281815A1
32277-EP2295402A2
32277-EP2301933A1
32277-EP2305640A2
32277-EP2308562A2
32277-EP2311827A1
32277-EP2371811A2
3385-03-3
385F033
6 alpha-fluoro-11 beta,16 alpha,17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone
6 alpha-fluorodihydroxy-16 alpha,17 alpha-isopropylidenedioxy-1,4-pregnadiene-3,20- dione
6-Fluoro-11,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,17-acetonide
6-Fluoro-11,21-dihydroxy-16,17-(isopropylidenedioxy)pregna-1,4-diene-3,20-dione
6alpha-Fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone
77326-96-6
78M02AA8KF
AB1010905
ABP000528
AC-3514
AC1L32UV
Aerobid
Aerobid M
Aerospan
AKOS025402038
AN-12914
BCP9000696
BPBio1_000711
BRD-K49577446-001-03-1
Bronalide
BSPBio_000645
C07005
CAS-3385-03-3
CCG-220643
CHEBI:5106
CHEMBL1512
CS-4713
DB00180
DSSTox_CID_25534
DSSTox_GSID_45534
DSSTox_RID_80936
DTXSID1045534
EINECS 222-193-2
Flunie
Flunisolida
Flunisolida [INN-Spanish]
Flunisolide (anhydrous)
Flunisolide [anhydrous]
Flunisolide [INN]
Flunisolide Hemihydrate
Flunisolide HFA
Flunisolide(Nasalide)/
Flunisolidum
Flunisolidum [INN-Latin]
GTPL7076
HMS1570A07
HMS2097A07
HMS2236A06
HMS3259L10
HMS3714A07
HY-B1121
LS-118464
Lunis
lunisolide anhydrous
MFCD00133324
MLS002153928
MolPort-005-943-434
Nasalide
Nasarel
NC00716
NCGC00016983-01
NCGC00179492-01
NCGC00179492-03
Nisolid
Pregna-1,4-diene-3,20-dione, 6-alpha-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
Pregna-1,4-diene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (6alpha,11beta,16alpha)-
Prestwick_223
Prestwick0_000643
Prestwick1_000643
Prestwick2_000643
Prestwick3_000643
Q834
Rhinalar
RS 3999
RS-3999
SCHEMBL4351
SMR001233272
Soluzione
SPBio_002566
Synaclyn
Syntaris
Tox21_110725
Tox21_110725_1
UNII-78M02AA8KF
ZINC4097305
Paragraph IV (Patent) Challenges for FLUNISOLIDE
Tradename Dosage Ingredient NDA Submissiondate
NASALIDE SPRAY, METERED;NASAL flunisolide 018148

US Patents and Regulatory Information for FLUNISOLIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc FLUNISOLIDE flunisolide SPRAY, METERED;NASAL 077436-001 Aug 9, 2007 RX No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb FLUNISOLIDE flunisolide SPRAY, METERED;NASAL 074805-001 Feb 20, 2002 AB RX No Yes   Start Trial   Start Trial   Start Trial
Hi Tech Pharma Co FLUNISOLIDE flunisolide SPRAY, METERED;NASAL 077704-001 Aug 3, 2006 AB RX No 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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