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NASONEX Drug Profile

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

Nasonex is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty-three countries.

The generic ingredient in NASONEX is mometasone furoate. There are twenty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NASONEX

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	57
Clinical Trials:	44
Patent Applications:	4,126
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	NASONEX at DailyMed

Pharmacology for NASONEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for NASONEX

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

Synonyms for NASONEX

(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

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

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 NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	AB	RX	Yes	Yes

Expired US Patents for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Merck Sharp Dohme	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Merck Sharp Dohme	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Merck Sharp Dohme	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997

Paragraph IV (Patent) Challenges for NASONEX

Drugname	Dosage	Strength	RLD	Submissiondate
	Nasal Spray	50 mcg/ Spray		2009-08-07

Non-Orange Book US Patents for NASONEX

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
6,180,781	Process for making mometasone furoate monohydrate

International Patents for NASONEX

Country	Document Number	Estimated Expiration
China	1059911
Norway	300548
Hungary	9300685
Luxembourg	90366

Supplementary Protection Certificates for NASONEX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT; NAT. REGISTRATION NO/DATE: 1-22208 19971111; FIRST REGISTRATION: FR AMM 343012.6 19970219
875032	Germany		PRODUCT NAME: MOMETASON-FUROAT-MONOHYDRAT; NAT. REGISTRATION NO/DATE: 40803.00.00 19980218; FIRST REGISTRATION: FRANKREICH NL 22055 19970219
5/1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT