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RYALTRIS Drug Patent Profile

When do Ryaltris patents expire, and when can generic versions of Ryaltris launch?

Ryaltris is a drug marketed by Glenmark Specialty and is included in one NDA. There are fourteen patents protecting this drug.

This drug has eighty-eight patent family members in thirty-two countries.

The generic ingredient in RYALTRIS is mometasone furoate; olopatadine hydrochloride. There are thirty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mometasone furoate; olopatadine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ryaltris

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 13, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RYALTRIS

International Patents:	88
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RYALTRIS
What excipients (inactive ingredients) are in RYALTRIS?	RYALTRIS excipients list
DailyMed Link:	RYALTRIS at DailyMed

See drug prices for RYALTRIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RYALTRIS

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

211746

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.

Pharmacology for RYALTRIS

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 RYALTRIS

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 RYALTRIS

RYALTRIS is protected by fourteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RYALTRIS

FDA Regulatory Exclusivity protecting RYALTRIS

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
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

International Patents for RYALTRIS

See the table below for patents covering RYALTRIS around the world.

Country	Patent Number	Title	Estimated Expiration
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)
Poland	3043773
Japan	2021514947	モメタゾン及びオロパタジンの組み合わせを用いた小児対象におけるアレルギー性鼻炎の治療
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)
Croatia	P20211515

Supplementary Protection Certificates for RYALTRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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