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AGAMREE Drug Patent Profile

When do Agamree patents expire, and what generic alternatives are available?

Agamree is a drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has forty-four patent family members in twenty countries.

The generic ingredient in AGAMREE is vamorolone. One supplier is listed for this compound. Additional details are available on the vamorolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Agamree

Agamree will be eligible for patent challenges on October 26, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AGAMREE

International Patents:	44
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AGAMREE
What excipients (inactive ingredients) are in AGAMREE?	AGAMREE excipients list
DailyMed Link:	AGAMREE at DailyMed

See drug prices for AGAMREE

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

Constraining patent/regulatory exclusivity:

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER

NDA:

215239

Dosage:

SUSPENSION;ORAL

^*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.

Anatomical Therapeutic Chemical (ATC) Classes for AGAMREE

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for AGAMREE

AGAMREE is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER.

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 AGAMREE

FDA Regulatory Exclusivity protecting AGAMREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes			Y

International Patents for AGAMREE

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	2805720
European Patent Office	3656385	MODULATEURS STÉROÏDIENS NON HORMONAUX DE NF-KB POUR LE TRAITEMENT D'UNE MALADIE (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE)
China	102076344	Non-hormonal steroid modulators of nf-kb for treatment of disease
Canada	2725008	MODULATEURS STEROIDIENS NON HORMONAUX DE NF-KB POUR LE TRAITEMENT D'UNE MALADIE (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE)
Poland	2805720
European Patent Office	4049663	MODULATEURS STÉROÏDIENS NON HORMONAUX DE NF-KB POUR LE TRAITEMENT D'UNE MALADIE (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE)