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Mometasone furoate - Generic Drug Details

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

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

Mometasone furoate has seventy patent family members in thirty-four countries.

There are twenty-nine drug master file entries for mometasone furoate. Twenty suppliers are listed for this compound.

Summary for mometasone furoate

International Patents:	70
US Patents:	13
Tradenames:	6
Applicants:	11
NDAs:	26
Drug Master File Entries:	29
Suppliers / Packagers:	20
Bulk Api Vendors:	57
Clinical Trials:	92
Patent Applications:	6,451
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mometasone furoate
DailyMed Link:	mometasone furoate at DailyMed

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

(1R,2S,10S,11S,13R,14R,15S,17S)-1-CHLORO-14-(2-CHLOROACETYL)-17-HYDROXY-2,13,15-TRIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-3,6-DIEN-14-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-6,7,8,9,10,11,12,13,14,15,16,17-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

BRN 4340538

BSPBio_000384

C07817

C27H30Cl2O6

CAS-83919-23-7

CCG-220572

CHEBI:47564

CHEMBL1161

CS-2389

D00690

Danitin

DR003147

DSSTox_CID_3333

DSSTox_GSID_23333

DSSTox_RID_76981

DTXSID4023333

Ecural

Elocon

Elocone

Elomet

Flumeta

HMS1569D06

HMS2096D06

HMS2235I14

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 hydrate

Mometasone Furoate Impurity G

MOMETASONE FUROATE MONOHYDRATE

Mometasone furoate, >=98% (HPLC)

Mometasone furoate, European Pharmacopoeia (EP) Reference Standard

Mometasone Furoate, pharmaceutical secondary standard; traceable to USP, PhEur and BP

Mometasone furoate, United States Pharmacopeia (USP) Reference Standard

Monovo

Nasonex

NCGC00016950-01

NCGC00179578-01

NCGC00179578-03

NCGC00179578-04

Nosorex

NSC-746171

NSC746171

Ovixan

PL071566

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

US Patents and Regulatory Information for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Generics	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	078541-001	May 28, 2008	AB	RX	No	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Merck Sharp Dohme	ELOCON	mometasone furoate	OINTMENT;TOPICAL	019543-001	Apr 30, 1987	AB	RX	Yes	Yes
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y

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Expired US Patents for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Merck Sharp Dohme	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008

Non-Orange Book US Patents for mometasone furoate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,662,142	Sinus delivery of sustained release therapeutics
7,686,798	Sinus delivery of sustained release therapeutics
7,691,094	Sinus delivery of sustained release therapeutics
7,951,132	Sinus delivery of sustained release therapeutics

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International Patents for mometasone furoate

Country	Document Number	Estimated Expiration
China	1030920
Germany	19875032
Ireland	913155
Finland	111078

Supplementary Protection Certificates for mometasone furoate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT; NAT. REGISTRATION NO/DATE: 1-22208 19971111; FIRST REGISTRATION: FR AMM 343012.6 19970219
C/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
0012	Netherlands		980012, 20110905, EXPIRES: 20160905
80012	Netherlands		PRODUCT NAME: MOMETASONI FUROAS MONOHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21613 19971209; FIRST REGISTRATION: FR NL22055 19970219