VILTOLARSEN - Generic Drug Details
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What are the generic sources for viltolarsen and what is the scope of patent protection?
Viltolarsen
is the generic ingredient in one branded drug marketed by Nippon Shinyaku and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Viltolarsen has fifty-three patent family members in twenty countries.
One supplier is listed for this compound.
Summary for VILTOLARSEN
International Patents: | 53 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 4 |
What excipients (inactive ingredients) are in VILTOLARSEN? | VILTOLARSEN excipients list |
DailyMed Link: | VILTOLARSEN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VILTOLARSEN
Generic Entry Date for VILTOLARSEN*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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 VILTOLARSEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NS Pharma, Inc. | Phase 2 |
Nippon Shinyaku Co., Ltd. | Phase 2 |
NS Pharma, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for VILTOLARSEN
US Patents and Regulatory Information for VILTOLARSEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | 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 VILTOLARSEN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2612917 | ACIDE NUCLÉIQUE ANTISENS (ANTISENSE NUCLEIC ACID) | ⤷ Sign Up |
Lithuania | 3018211 | ⤷ Sign Up | |
Japan | 6647430 | ⤷ Sign Up | |
Poland | 2612917 | ⤷ Sign Up | |
Japan | 2021072820 | アンチセンス核酸 (ANTISENSE NUCLEIC ACID) | ⤷ Sign Up |
Japan | 2020072724 | アンチセンス核酸 (ANTISENSE NUCLEIC ACID) | ⤷ Sign Up |
Japan | 2019062913 | アンチセンス核酸 (ANTISENSE NUCLEIC ACID) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |