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.
Latest 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 Issue Date Used in PTA Calculation Critical | 29 Apr, 2003 | US6555133 |
| Recordation of Patent Grant Mailed Critical | 29 Apr, 2003 | US6555133 |
| Issue Notification Mailed Critical | 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 Critical | 28 Feb, 2003 | US6555133 |
| Issue Fee Payment Received Critical | 19 Feb, 2003 | US6555133 |
| Issue Fee Payment Verified Critical | 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 |
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
Explore Our Curated Drug Screens
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 |
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| Agouron Pharms |
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| Gilead |
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| Gilead Sciences |
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| Gilead Sciences Inc |
| |||||||||||||||||
| Glaxosmithkline |
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| Janssen R And D |
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| Msd Sub Merck |
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| Roche |
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| Viiv Hlthcare |
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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 - tablet form for oral use, capsule 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 |