VITEKTA Drug Patent Profile
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When do Vitekta patents expire, and when can generic versions of Vitekta launch?
Vitekta is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug.
This drug has ninety-two patent family members in thirty-six countries.
The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.
DrugPatentWatch® Generic Entry Outlook for Vitekta
Vitekta was eligible for patent challenges on August 27, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 26, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for VITEKTA?
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Summary for VITEKTA
International Patents: | 92 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Patent Applications: | 1,182 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VITEKTA |
DailyMed Link: | VITEKTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VITEKTA
Generic Entry Date for VITEKTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 VITEKTA
VITEKTA is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VITEKTA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 VITEKTA
4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷ Sign Up
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 |
EU/EMA Drug Approvals for VITEKTA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences International Ltd | Vitekta | elvitegravir | EMEA/H/C/002577 Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir. |
Withdrawn | no | no | no | 2013-11-13 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VITEKTA
See the table below for patents covering VITEKTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2470365 | COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR) | ⤷ Sign Up |
Norway | 20043004 | ⤷ Sign Up | |
Lithuania | 3281939 | ⤷ Sign Up | |
Malaysia | 136173 | 4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VITEKTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1564210 | 2013/052 | Ireland | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR OR A HYDRATE, SOLVATE, TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 |
1564210 | 203 5022-2013 | Slovakia | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527 |
1564210 | C20130029 00095 | Estonia | ⤷ Sign Up | CHANGE OF OWNER'S ADDRESS |
1564210 | 1390052-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |