VAMOROLONE - Generic Drug Details
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What are the generic sources for vamorolone and what is the scope of freedom to operate?
Vamorolone
is the generic ingredient in one branded drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vamorolone has forty-six patent family members in twenty-two countries.
One supplier is listed for this compound.
Summary for VAMOROLONE
| International Patents: | 46 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 7 |
| Patent Applications: | 201 |
| What excipients (inactive ingredients) are in VAMOROLONE? | VAMOROLONE excipients list |
| DailyMed Link: | VAMOROLONE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VAMOROLONE
Generic Entry Date for VAMOROLONE*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER 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.
Recent Clinical Trials for VAMOROLONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Santhera Pharmaceuticals | Phase 2 |
| ReveraGen BioPharma, Inc. | Phase 1/Phase 2 |
| Newcastle University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for VAMOROLONE
US Patents and Regulatory Information for VAMOROLONE
| 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 | Y | Y | ⤷ 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 | ⤷ 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 VAMOROLONE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 103739647 | Non-hormonal steroid modulators of nf-kb for treatment of disease | ⤷ Sign Up |
| Lithuania | 2805720 | ⤷ Sign Up | |
| Japan | 6204408 | ⤷ Sign Up | |
| Mexico | 2010012976 | MODULADORES DE NF-KB ESTEROIDES NO HORMONALES PARA EL TRATAMIENTO DE ENFERMEDADES. (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE.) | ⤷ Sign Up |
| Hong Kong | 1201184 | 用於治療疾病的 的非激素甾體調節劑 (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE NF-KB) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VAMOROLONE
| 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 |
