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AGAMREE Drug Patent Profile

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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-six patent family members in twenty-two 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

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Summary for AGAMREE

International Patents:	46
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

Drug patent expirations by year for AGAMREE

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

Generic Entry Date for AGAMREE^: ⤷ Sign Up* 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.

US Patents and Regulatory Information for AGAMREE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AGAMREE is ⤷ Sign Up.

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

Non-hormonal steroid modulators of NF-kB for treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Non-hormonal steroid modulators of NF-κB for treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

FDA Regulatory Exclusivity protecting AGAMREE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

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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
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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 AGAMREE

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

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Country	Patent Number	Title	Estimated Expiration
Hungary	E046243		⤷ Sign Up
Cyprus	1121984		⤷ Sign Up
South Korea	101591482		⤷ Sign Up
Denmark	2444092		⤷ Sign Up
New Zealand	589444	NON-HORMONAL STEROID MODULATORS OF NF-Kappa B FOR TREATMENT OF DISEASE	⤷ Sign Up
Denmark	2805720		⤷ Sign Up
Portugal	2805720		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AGAMREE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805720	301273	Netherlands	⤷ Sign Up	PRODUCT NAME: VAMOROLONE; REGISTRATION NO/DATE: EU/1/23/1776 20231215
2805720	CA 2024 00018	Denmark	⤷ Sign Up	PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description