Sustiva Patent Expiration

Sustiva is a drug owned by Bristol Myers Squibb Co. It is protected by 13 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 06, 2019. Details of Sustiva's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6238695

(Pediatric)

Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
Oct, 2019

(5 years ago)

Expired
US6555133

(Pediatric)

Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
Oct, 2019

(5 years ago)

Expired
US6555133 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
Apr, 2019

(5 years ago)

Expired
US6238695 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
Apr, 2019

(5 years ago)

Expired
US6639071

(Pediatric)

Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Aug, 2018

(6 years ago)

Expired
US6939964

(Pediatric)

Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Jul, 2018

(6 years ago)

Expired
US6639071 Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Feb, 2018

(6 years ago)

Expired
US6939964 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Jan, 2018

(6 years ago)

Expired
US5663169

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase
Mar, 2015

(9 years ago)

Expired
US5663169 Benzoxazinones as inhibitors of HIV reverse transcriptase
Sep, 2014

(10 years ago)

Expired
US5519021

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase
Nov, 2013

(11 years ago)

Expired
US5519021 Benzoxazinones as inhibitors of HIV reverse transcriptase
May, 2013

(11 years ago)

Expired
US5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase
Aug, 2012

(12 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Sustiva's patents.

Given below is the list of recent legal activities going on the following patents of Sustiva.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 29 Apr, 2003 US6555133
Recordation of Patent Grant Mailed 29 Apr, 2003 US6555133
Issue Notification Mailed 10 Apr, 2003 US6555133
Receipt into Pubs 14 Mar, 2003 US6555133
Receipt into Pubs 06 Mar, 2003 US6555133
Receipt into Pubs 03 Mar, 2003 US6555133
Application Is Considered Ready for Issue 28 Feb, 2003 US6555133
Issue Fee Payment Received 19 Feb, 2003 US6555133
Issue Fee Payment Verified 19 Feb, 2003 US6555133
Receipt into Pubs 11 Feb, 2003 US6555133


FDA has granted several exclusivities to Sustiva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sustiva, 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 Sustiva.

Exclusivity Information

Sustiva holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Sustiva's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) May 02, 2016
Pediatric Exclusivity(PED) Nov 02, 2016

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Sustiva 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 Sustiva's family patents as well as insights into ongoing legal events on those patents.

Sustiva's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Sustiva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 06, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Sustiva Generic API suppliers:

Efavirenz is the generic name for the brand Sustiva. 7 different companies have already filed for the generic of Sustiva, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sustiva's generic

How can I launch a generic of Sustiva before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Sustiva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sustiva's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Sustiva -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
600 mg 09 Apr, 2009 1 17 Feb, 2016 20 Jan, 2018 Eligible
50 mg, 100 mg and 200 mg 03 Nov, 2016 1 15 Dec, 2017 06 Apr, 2019 Eligible

Alternative Brands for Sustiva

Sustiva which is used for managing HIV infection in combination with other antiviral drugs., has several other brand drugs in the same treatment category and using the same active ingredient (Efavirenz). 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
Kaletra used for treating HIV-1 infection in combination with other antiretroviral agents.
Agouron Pharms
Viracept Used for managing HIV infection.
Gilead
Emtriva Used for treating HIV infection in adults.
Truvada Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla

(uses Efavirenz)

Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Viread used for managing chronic hepatitis B and HIV infections in both adults and pediatric patients.
Descovy Used for managing and treating HIV infection.
Genvoya Used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Odefsey Used for treating HIV infection.
Vitekta Used for managing HIV infection.
Biktarvy Used for treating HIV infection.
Complera Used for managing and treating HIV infection.
Stribild Used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Glaxosmithkline
Agenerase Used for managing HIV infection.
Janssen R And D
Intelence used for treating HIV-1 infection in patients who are treatment-experienced and have evidence of viral replication and resistance to certain antiretroviral drugs.
Msd Sub Merck
Isentress Used for treating HIV infection by inhibiting integrase.
Isentress Hd Used for treating HIV infection.
Roche
Fuzeon Used for managing HIV infection.
Viiv Hlthcare
Dovato Used for the treatment of HIV infection.
Epivir Used for treating HIV infection.
Juluca Used for managing HIV infection.
Lexiva Used for managing and treating HIV infection.
Epzicom Used for treating HIV infection.
Combivir Used for the treatment of HIV.
Trizivir Used for treating patients infected with HIV.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Efavirenz, Sustiva's active ingredient. Check the complete list of approved generic manufacturers for Sustiva





About Sustiva

Sustiva is a drug owned by Bristol Myers Squibb Co. It is used for managing HIV infection in combination with other antiviral drugs. Sustiva uses Efavirenz as an active ingredient. Sustiva was launched by Bristol Myers Squibb in 1998.

Approval Date:

Sustiva was approved by FDA for market use on 17 September, 1998.

Active Ingredient:

Sustiva uses Efavirenz as the active ingredient. Check out other Drugs and Companies using Efavirenz ingredient

Treatment:

Sustiva is used for managing HIV infection in combination with other antiviral drugs.

Dosage:

Sustiva is available in the following dosage forms - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
600MG TABLET Discontinued ORAL