RUKOBIA Drug Patent Profile
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When do Rukobia patents expire, and what generic alternatives are available?
Rukobia is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug.
This drug has thirty-nine patent family members in thirty countries.
The generic ingredient in RUKOBIA is fostemsavir tromethamine. One supplier is listed for this compound. Additional details are available on the fostemsavir tromethamine profile page.
DrugPatentWatch® Generic Entry Outlook for Rukobia
Rukobia will be eligible for patent challenges on July 2, 2024. 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 July 13, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for RUKOBIA
International Patents: | 39 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 1 |
Patent Applications: | 62 |
Drug Prices: | Drug price information for RUKOBIA |
What excipients (inactive ingredients) are in RUKOBIA? | RUKOBIA excipients list |
DailyMed Link: | RUKOBIA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RUKOBIA
Generic Entry Date for RUKOBIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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 RUKOBIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Orlando Immunology Center | Phase 4 |
ViiV Healthcare | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for RUKOBIA
US Patents and Regulatory Information for RUKOBIA
RUKOBIA is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RUKOBIA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 RUKOBIA
Prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salts of prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting RUKOBIA
NEW CHEMICAL ENTITY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950-001 | Jul 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950-001 | Jul 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950-001 | Jul 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950-001 | Jul 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | 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 RUKOBIA
See the table below for patents covering RUKOBIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1725569 | ⤷ Try a Trial | |
Georgia, Republic of | P20094736 | PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS | ⤷ Try a Trial |
Hong Kong | 1096687 | Prodrugs of piperazine and substituted piperidine antiviral agents | ⤷ Try a Trial |
Serbia | 50567 | PROLEKOVI ANTIVIRUSNIH SREDSTAVA PIPERAZINA I SUPSTITUISANOG PIPERIDINA (PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS) | ⤷ Try a Trial |
Hong Kong | 1148533 | PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS | ⤷ Try a Trial |
Cyprus | 1107419 | ⤷ Try a Trial | |
Denmark | 1725569 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |