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 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	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
Serbia	62383	STABILNA FARMACEUTSKA KOMPOZICIJA SA FIKSNOM DOZOM KOJA SADRŽI MOMETAZON I OLOPATADIN ZA NAZALNU PRIMENU (STABLE FIXED DOSE PHARMACEUTICAL COMPOSITION COMPRISING MOMETASONE AND OLOPATADINE FOR NASAL ADMINISTRATION)	⤷ Sign Up
Portugal	3043773		⤷ Sign Up
South Korea	102709429		⤷ 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
0112669	96C0002	Belgium	⤷ Sign Up	PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	2022C/520	Belgium	⤷ Sign Up	PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
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	57/2021	Austria	⤷ Sign Up	PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: 140638 20210426
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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