Mometasone furoate; olopatadine hydrochloride - Generic Drug Details

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What are the generic 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 Speclt and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mometasone furoate; olopatadine hydrochloride has ninety patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for mometasone furoate; olopatadine hydrochloride

International Patents:	90
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	mometasone furoate; olopatadine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for mometasone furoate; olopatadine hydrochloride

Generic Entry Date for mometasone furoate; olopatadine hydrochloride^: ⤷ Sign Up* 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
MEDA Pharma GmbH & Co. KG	Phase 2
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

Anatomical Therapeutic Chemical (ATC) Classes for mometasone furoate; olopatadine hydrochloride

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for mometasone furoate; olopatadine hydrochloride

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

International Patents for mometasone furoate; olopatadine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019006173		⤷ Sign Up
Russian Federation	2020126691	ЛЕЧЕНИЕ АЛЛЕРГИЧЕСКОГО РИНИТА У СУБЪЕКТОВ ДЕТСКОЙ ВОЗРАСТНОЙ КАТЕГОРИИ С ПРИМЕНЕНИЕМ КОМБИНАЦИИ МОМЕТАЗОНА И ОЛОПАТАДИНА	⤷ Sign Up
China	115444851	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)	⤷ Sign Up
China	112773808	使用莫米松和奥洛他定的组合治疗过敏性鼻炎 (Treatment of allergic rhinitis using combination of mometasone and olopatadine)	⤷ Sign Up
Taiwan	I790316		⤷ Sign Up
Lithuania	3468532		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for mometasone furoate; olopatadine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2190041-0	Sweden	⤷ Sign Up	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
3043773	301154	Netherlands	⤷ Sign Up	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
3043773	SPC/GB21/077	United Kingdom	⤷ Sign Up	PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	C202130060	Spain	⤷ Sign Up	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	⤷ Sign Up	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
0548114	SPC/GB97/064	United Kingdom	⤷ Sign Up	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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.