Vamorolone - Generic Drug Details
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What are the generic sources for vamorolone and what is the scope of patent protection?
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-five patent family members in twenty-one countries.
One supplier is listed for this compound.
Summary for vamorolone
| International Patents: | 45 |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Catalyst Pharms | AGAMREE | vamorolone | SUSPENSION;ORAL | 215239-001 | Oct 26, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | ||||
| 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 | Y | Y | ⤷ 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 vamorolone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 2805720 | ⤷ Try a Trial | |
| European Patent Office | 2278978 | MODULATEURS STÉROÏDIENS NON HORMONAUX DE NF-KB POUR LE TRAITEMENT D UNE MALADIE (NON-HORMONAL STEROID MODULATORS OF NF-KB FOR TREATMENT OF DISEASE) | ⤷ Try a Trial |
| Denmark | 2278978 | ⤷ Try a Trial | |
| South Korea | 101749032 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| 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) | ⤷ 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 |
