Mometasone furoate; olopatadine hydrochloride - Generic Drug Details

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

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			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
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			Y

International Patents for mometasone furoate; olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20200125625	모메타손 및 올로파타딘의 조합을 사용하는 소아 대상체의 알레르기성 비염의 치료
Mexico	2020008741	TRATAMIENTO DE LA RINITIS ALERGICA EN SUJETOS PEDIATRICOS CON UNA COMBINACION DE MOMETASONA Y OLOPATADINA. (TREATMENT OF ALLERGIC RHINITIS IN PEDIATRIC SUBJECTS USING A COMBINATION OF MOMETASONE AND OLOPATADINE.)
Russian Federation	2015128497	СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С ФИКСИРОВАННОЙ ДОЗОЙ, СОДЕРЖАЩАЯ МОМЕТАЗОН И ОЛОПАТАДИН
China	112870203	用于治疗鼻炎的分配装置和药物组合物 (Dispensing device and pharmaceutical composition for treating rhinitis)
Mexico	2020003035	TRATAMIENTO DE RINITIS ALERGICA UTILIZANDO UNA COMBINACION DE MOMETASONA Y OLOPATADINA. (TREATMENT OF ALLERGIC RHINITIS USING A COMBINATION OF MOMETASONE AND OLOPATADINE.)
South Africa	201504740	TREATMENT OF ALLERGIC RHINITIS USING A COMBINATION OF MOMETASONE AND OLOPATADINE
World Intellectual Property Organization (WIPO)	2015049665

Supplementary Protection Certificates for mometasone furoate; olopatadine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
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	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426