Mometasone furoate - Generic Drug Details

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

Mometasone furoate is the generic ingredient in six branded drugs marketed by Merck Sharp Dohme, Acp Nimble, Anda Repository, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Perrigo Israel, Perrigo New York, Torrent, Amneal Pharms, and Apotex Inc, and is included in twenty-seven NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mometasone furoate has twenty-four patent family members in ten countries.

There are thirty drug master file entries for mometasone furoate. Nineteen suppliers are listed for this compound.

Summary for mometasone furoate

International Patents:	24
US Patents:	10
Tradenames:	6
Applicants:	12
NDAs:	27
Drug Master File Entries:	30
Suppliers / Packagers:	19
Bulk Api Vendors:	62
Clinical Trials:	101
Patent Applications:	6,152
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for mometasone furoate
Drug Sales Revenues:	Drug sales revenues for mometasone furoate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mometasone furoate
DailyMed Link:	mometasone furoate at DailyMed

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Drug Sales Revenue Trends for mometasone furoate

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Recent Clinical Trials for mometasone furoate

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Sponsor	Phase
Lyra Therapeutics	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Jeffrey Glassberg	Phase 2

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Recent Litigation for mometasone furoate

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District Court Litigation

Case Name	Date
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-08
MERCK SHARP & DOHME CORP. v. APOTEX INC.	2015-04-02
Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC	2015-03-20

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Pharmacology for mometasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for mometasone furoate

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Synonyms for mometasone furoate

(11beta,16alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2-carboxylate
(11beta,16alpha)-9,21-Dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione
(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl furan-2-carboxylate
(9beta,10alpha,11alpha,14beta,16alpha,17alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2-carboxylate
[(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloranyl-17-(2-chloranylethanoyl)-10,13,16-trimethyl-11-oxidanyl-3-oxidanylidene-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate
[(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate
04201GDN4R
11?,16?)-9,21-Dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl 2-furoate
2-furancarboxylic acid [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloro-1-oxoethyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] ester
83919-23-7
9,21-dichloro-11beta-hydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2-carboxylate
9,21-Dichloro-11beta,17-dihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)
919M237
A840685
AB2000407
AC-941
AC1L9AZS
AK163902
AKOS015994732
AN-15438
Asmanex
Asmanex HFA
Asmanex Twisthaler
BC228151
BDBM50148733
BPBio1_000424
BRD-K60640630-001-03-7
BRD-K60640630-001-11-0
BRN 4340538
BSPBio_000384
C07817
C27H30Cl2O6
CAS-83919-23-7
CCG-220572
CHEBI:47564
CHEMBL1161
CS-2389
D00690
Danitin
DSSTox_CID_3333
DSSTox_GSID_23333
DSSTox_RID_76981
DTXSID4023333
Ecural
Elocone
Elomet
Flumeta
HMS1569D06
HMS2096D06
HMS2235I14
HMS3713D06
HY-13693
KS-00000SPL
KS-1275
LAS 41002
M2354
MLS002153879
MolPort-003-849-257
Mometasone 17-(2-furoate)
mometasone 17-furoate
mometasone furancarboxylate
Mometasone furoate (JAN/USP)
Mometasone furoate [USAN:USP:JAN]
Mometasone Furoate Impurity G
MOMETASONE FUROATE MONOHYDRATE
Mometasone furoate, >=98% (HPLC)
Mometasone furoate, European Pharmacopoeia (EP) Reference Standard
Mometasone Furoate, Pharmaceutical Secondary Standard; Certified Reference Material
Mometasone furoate, United States Pharmacopeia (USP) Reference Standard
Monovo
Nasonex
NCGC00016950-01
NCGC00179578-01
NCGC00179578-03
NCGC00179578-04
Nosorex
NSC-746171
NSC746171
Ovixan
Pregna-1,20-dione, 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-, (11.beta.,16.alpha.)-
Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-, (11beta,16alpha)-
Prestwick_924
Prestwick0_000572
Prestwick1_000572
Prestwick2_000572
Prestwick3_000572
Q-101380
Rimelon
s1987
Sch 32088
Sch-32088
SCHEMBL4568
Sinuva
SMR001233233
SPBio_002603
SR-01000841209
SR-01000841209-2
ST24048112
TL8005500
Tox21_110705
Tox21_110705_1
UNII-04201GDN4R
WOFMFGQZHJDGCX-ZULDAHANSA-N
ZINC3938677

Paragraph IV (Patent) Challenges for MOMETASONE FUROATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NASONEX	SPRAY, METERED;NASAL	mometasone furoate	020762	2009-08-07
ELOCON	LOTION;TOPICAL	mometasone furoate	019796	2004-06-10
ELOCON	CREAM;TOPICAL	mometasone furoate	019625

US Patents and Regulatory Information for mometasone furoate

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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
Fougera Pharms	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	076171-001	Apr 8, 2005	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	Start Trial	Start Trial				Start Trial
Apotex Inc	MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	091161-001	Mar 22, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008		RX	Yes	No	Start Trial	Start Trial				Start Trial
Glenmark Generics	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	078541-001	May 28, 2008	AB	RX	No	Yes	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

Expired US Patents for mometasone furoate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	Start Trial	Start Trial
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	Start Trial	Start Trial
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	Start Trial	Start Trial
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	Start Trial	Start Trial
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for mometasone furoate

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Country	Patent Number	Estimated Expiration
European Patent Office	2320832	Start Trial
European Patent Office	3103422	Start Trial
Russian Federation	2007140909	Start Trial
European Patent Office	2298319	Start Trial
Japan	2006520786	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for mometasone furoate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium	Start Trial	PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114	SPC/GB97/064	United Kingdom	Start Trial	PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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