agamree Drug Patent Profile
✉ Email this page to a colleague
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-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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for agamree?
- What are the global sales for agamree?
- What is Average Wholesale Price for agamree?
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 |
![agamree drug patent expirations Drug patent expirations by year for agamree](/p/graph/s/t/agamree-patent-expirations.png)
![Drug Prices for agamree](/p/graph/drug-price/agamree.png)
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.
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
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
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 | ||||
>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 | 20110020868 | NON-HORMONAL STEROID MODULATORS OF NF-κB FOR TREATMENT OF DISEASE | ⤷ Sign Up |
Denmark | 2278978 | ⤷ Sign Up | |
Denmark | 2444092 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
South Korea | 20170013406 | 질환의 치료를 위한 NF-κB 의 비호르몬성 스테로이드 조절제 (- NON-HORMONAL STEROID MODULATORS OF NF-B FOR TREATMENT OF DISEASE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for agamree
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2805720 | CA 2024 00018 | Denmark | ⤷ Sign Up | PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215 |
2805720 | 301273 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VAMOROLONE; REGISTRATION NO/DATE: EU/1/23/1776 20231215 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |