MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for mometasone furoate; olopatadine hydrochloride and what is the scope of patent protection?

Mometasone furoate; olopatadine hydrochloride is the generic ingredient in one branded drug marketed by Glenmark Specialty and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mometasone furoate; olopatadine hydrochloride has eighty-eight patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

International Patents:	88
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

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

Sponsor	Phase
Glenmark Specialty S.A.	Phase 3
Glenmark Pharmaceuticals Ltd. India	Phase 2

See all MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE clinical trials

Pharmacology for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

US Patents and Regulatory Information for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y

International Patents for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2017206560	モメタゾン及びオロパタジンを有する安定な定用量薬剤組成物 (STABLE FIXED DOSE PHARMACEUTICAL COMPOSITION COMPRISING MOMETASONE AND OLOPATADINE)
Brazil	112015018252	composição farmacêutica aquosa de dose fixa estável para administração nasal para um ser humano, composição de suspensão aquosa farmacêutica de dose fixa estável para administração nasal para um ser humano, suspensão estável adequada para administração nasal a um ser humano, método para tratar rinite em um ser humano necessitando do mesmo, uso da composição farmacêutica para administração nasal, método para liberar uma composição farmacêutica e kit
Japan	6203967
European Patent Office	3468532	DISPOSITIF DE DISTRIBUTION ET COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DE LA RHINITE (DISPENSING DEVICE AND PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF RHINITIS)
Cyprus	1124675
Lithuania	3043773
European Patent Office	3755375	TRAITEMENT DE LA RHINITE ALLERGIQUE CHEZ DES SUJETS PÉDIATRIQUES À L'AIDE D'UNE COMBINAISON DE MOMÉTASONE ET D'OLOPATADINE (TREATMENT OF ALLERGIC RHINITIS IN PEDIATRIC SUBJECTS USING A COMBINATION OF MOMETASONE AND OLOPATADINE)

Supplementary Protection Certificates for MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	CA 2021 00050	Denmark		PRODUCT NAME: MOMETASON ELLER ET SALT DERAF OG OLOPATADIN ELLER ET SALT DERAF; NAT. REG. NO/DATE: 63820 20210706; FIRST REG. NO/DATE: AT 140638 20210426
3043773	C202130060	Spain		PRODUCT NAME: MOMETASONA O UNA SAL DE LA MISMA Y OLOPATADINA O UNA SAL DE LA MISMA; NATIONAL AUTHORISATION NUMBER: 86059-SE/H/2040/001/DC; DATE OF AUTHORISATION: 20210701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 140638; DATE OF FIRST AUTHORISATION IN EEA: 20210419
3043773	2021045	Norway		PRODUCT NAME: MOMETASON ELLER ET SALT DERAV OG OLOPATADIN ELLER ET SALT DERAV; NAT. REG. NO/DATE: 20-13278 20210709; FIRST REG. NO/DATE: 140638 20210426
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	122021000085	Germany		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: 2205824.00.00 20211117; FIRST REGISTRATION: OESTERREICH 140638 20210426
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426