AGAMREE Drug Patent Profile
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When do Agamree patents expire, and when can generic versions of Agamree launch?
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-five patent family members in twenty-one 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: | 45 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AGAMREE
Generic Entry Date for AGAMREE*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER NDA:
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
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Non-hormonal steroid modulators of NF-κB for treatment of disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
FDA Regulatory Exclusivity protecting AGAMREE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Catalyst Pharms | AGAMREE | vamorolone | SUSPENSION;ORAL | 215239-001 | Oct 26, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Catalyst Pharms | AGAMREE | vamorolone | SUSPENSION;ORAL | 215239-001 | Oct 26, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Catalyst Pharms | AGAMREE | vamorolone | SUSPENSION;ORAL | 215239-001 | Oct 26, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20160015408 | 질환의 치료를 위한 NF-κB 의 비호르몬성 스테로이드 조절제 (NON-HORMONAL STEROID MODULATORS OF NF-κB FOR TREATMENT OF DISEASE) | ⤷ Try a Trial |
South Korea | 101701404 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2009155056 | ⤷ Try a Trial | |
Brazil | PI0909564 | composto para uso na fabicação de um medicamento para reduzir os sintomas de uma doença selecionada do grupo consistindo de distrofia muscular, artrite, traumatismo craniocerebral, lesão da medula espinal, sepsia, doença reumatica, arteroesclerose de câncer, diabetes tipo 1, diabetes tipo 2, doença renal de leptospirose, glaucoma, doença retinal, envelhecimento,dor de cabeça, dores, síndrome de dor regional complexa, hipertrofia cardíaca, deperdição muscular, desordens catabólicas, obesidade, retardo no crescimento fetal, hipercolesterolemia, doença cardíaca, insuficiência cardíaca crônica, isquemia/reperfusão, avc, aneurisma cerebral, angina pectoris, doença pulmonar, fibrose cística, lesão pulmonar induzida por ácido, hipertensãopulmonar, asma, doença pulmonar obstrutiva crônica, síndrome de sjogren, doença da membrana hialina, doença renal, doença glomerular, doença do fígado alcoólica, doenças do intestino, endometriose peritoneal, doenças da pele, sinusite nasal, mesotelioma, displasia ecodérmica anidrótica-id, doença de behcet, incontinencia pigmentar, tuberculose, asma, doença de crohn, colite, alergia ocular, apendicite, doença de paget, pancreatite, periodontite, endometriose, doença do intestino inflamatória, doença pulmonar inflamatória, doenças induzidas por sílica, apnéia de sono, aids, hiv-1, doenças autoimunes, síndrome antifosfolipídica, lúpus, lúpus nefrite, febre de malta familiar, síndrome de febre periódica hereditária, doenças de estresse psicossocial, doenças neuropatológicas, polineuropatia amiloidótica familiar, neuropatia inflamatória, doença de parkinson, esclerose múltipla, doença de alzheimer, esclerose lateral amiotrópica, doença de huntington, cataratas, e perda da audição e composição farmacêutica | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |