MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE - Generic Drug Details

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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:	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 Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glenmark Specialty	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
Philippines	12018502518	DISPENSING DEVICE AND PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF RHINITIS	⤷ Sign Up
Australia	2019224850	Treatment of allergic rhinitis in pediatric subjects using a combination of mometasone and olopatadine	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015049665		⤷ Sign Up
Japan	2016534142	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	⤷ Sign Up
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.)	⤷ Sign Up
Spain	2891729		⤷ Sign Up
Japan	6768733		⤷ 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	122021000085	Germany	⤷ Sign Up	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
0548114	SPC/GB97/064	United Kingdom	⤷ Sign Up	PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	21C1057	France	⤷ Sign Up	PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
3043773	CA 2021 00050	Denmark	⤷ Sign Up	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	57/2021	Austria	⤷ Sign Up	PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: 140638 20210426
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
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
>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.