Vitekta is a drug owned by Gilead Sciences Inc. It is protected by 6 US drug patents filed from 2014 to 2021 out of which none have expired yet. Vitekta's patents have been open to challenges since 27 August, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 26, 2027. Details of Vitekta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7635704 | Stable crystal of 4-oxoquinoline compound |
Oct, 2026
(1 year, 5 months from now) | Active |
| US8981103 | Stable crystal of 4-oxoquinoline compound |
Oct, 2026
(1 year, 5 months from now) | Active |
| US7176220 | 4-oxoquinoline compound and use thereof as pharmaceutical agent |
Aug, 2026
(1 year, 3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8981103 (Pediatric) | Stable crystal of 4-oxoquinoline compound |
Apr, 2027
(1 year, 11 months from now) | Active |
|
US7635704 (Pediatric) | Stable crystal of 4-oxoquinoline compound |
Apr, 2027
(1 year, 11 months from now) | Active |
|
US7176220 (Pediatric) | 4-oxoquinoline compound and use thereof as pharmaceutical agent |
Feb, 2027
(1 year, 9 months from now) | Active |
FDA has granted several exclusivities to Vitekta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vitekta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vitekta.
Exclusivity Information
Vitekta holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Vitekta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2017 |
| New Product(NP) | Sep 24, 2017 |
US patents provide insights into the exclusivity only within the United States, but Vitekta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vitekta's family patents as well as insights into ongoing legal events on those patents.
Vitekta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vitekta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vitekta Generics:
There are no approved generic versions for Vitekta as of now.
Alternative Brands for Vitekta
Vitekta which is used for managing HIV infection., has several other brand drugs in the same treatment category and using the same active ingredient (Elvitegravir). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||||||||
| Agouron Pharms |
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| Bristol Myers Squibb |
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| Gilead |
| |||||||||||||
| Gilead Sciences |
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| Gilead Sciences Inc |
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| Glaxosmithkline |
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| Msd Sub Merck |
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| Viiv Hlthcare |
| |||||||||||||
About Vitekta
Vitekta is a drug owned by Gilead Sciences Inc. It is used for managing HIV infection. Vitekta uses Elvitegravir as an active ingredient. Vitekta was launched by Gilead Sciences Inc in 2014.
Approval Date:
Vitekta was approved by FDA for market use on 24 September, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vitekta is 24 September, 2014, its NCE-1 date is estimated to be 27 August, 2016.
Active Ingredient:
Vitekta uses Elvitegravir as the active ingredient. Check out other Drugs and Companies using Elvitegravir ingredient
Treatment:
Vitekta is used for managing HIV infection.
Dosage:
Vitekta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Discontinued | ORAL |
| 85MG | TABLET | Discontinued | ORAL |