Stribild is a drug owned by Gilead Sciences Inc. It is protected by 35 US drug patents filed from 2013 to 2021. Out of these, 14 drug patents are active and 21 have expired. Stribild'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 06, 2033. Details of Stribild'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. | |||
| US8148374 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(4 years from now) | Active |
| 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). | |||
|
US10039718 (Pediatric) | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Apr, 2033
(7 years from now) | Active |
| US10039718 | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Oct, 2032
(7 years from now) | Active |
|
US8633219 (Pediatric) | Combination therapy |
Oct, 2030
(5 years from now) | Active |
| US8633219 | Combination therapy |
Apr, 2030
(4 years from now) | Active |
|
US8148374 (Pediatric) | Modulators of pharmacokinetic properties of therapeutics |
Mar, 2030
(4 years from now) | Active |
|
US9891239 (Pediatric) | Modulators of pharmacokinetic properties of therapeutics |
Mar, 2030
(4 years from now) | Active |
| US9891239 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(4 years from now) | Active |
|
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 |
|
US8716264 (Pediatric) | Compositions and methods for combination antiviral therapy |
Jul, 2024
(9 months ago) |
Expired
|
| US8716264 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8592397 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US9744181 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US9457036 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
|
US6703396 (Pediatric) | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Sep, 2021
(3 years ago) |
Expired
|
|
US6642245 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
May, 2021
(4 years ago) |
Expired
|
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(4 years ago) |
Expired
|
| US6642245 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Nov, 2020
(4 years ago) |
Expired
|
|
US5922695 (Pediatric) | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jan, 2018
(7 years ago) |
Expired
|
|
US5977089 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(7 years ago) |
Expired
|
|
US6043230 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(7 years ago) |
Expired
|
|
US5935946 (Pediatric) | Nucleotide analog composition and synthesis method |
Jan, 2018
(7 years ago) |
Expired
|
|
US5914331 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jan, 2018
(7 years ago) |
Expired
|
| US5977089 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 years ago) |
Expired
|
| US5935946 | Nucleotide analog composition and synthesis method |
Jul, 2017
(7 years ago) |
Expired
|
| US6043230 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 years ago) |
Expired
|
| US5922695 | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jul, 2017
(7 years ago) |
Expired
|
| US5914331 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jul, 2017
(7 years ago) |
Expired
|
|
US5814639 (Pediatric) | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Mar, 2016
(9 years ago) |
Expired
|
| US5814639 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Sep, 2015
(9 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Stribild and ongoing litigations to help you estimate the early arrival of Stribild generic.
Stribild's Litigations
Stribild been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 05, 2001, against patent number US6642245. The petitioner , challenged the validity of this patent, with DIONNE as the respondent. Click below to track the latest information on how companies are challenging Stribild's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9891239 | August, 2013 |
Decision
(20 Jul, 2016) | Manoj C. Desai et al | |
| US5935946 | June, 2014 |
Terminated-Denied
(17 Dec, 2014) | Gilead Sciences, Inc. | MYLAN PHARMACEUTICALS INC. |
| US5922695 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US5977089 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US6043230 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US8633219 | August, 2011 |
Decision
(19 Jul, 2012) | Yuji Matsuzaki et al | |
| US6703396 | April, 2002 |
Decision
(04 Apr, 2002) | DIONNE | |
| US6642245 | July, 2001 |
Decision
(05 Jul, 2001) | DIONNE | |
FDA has granted some exclusivities to Stribild. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Stribild, 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 Stribild.
Exclusivity Information
Stribild holds 4 exclusivities. All of its exclusivities have expired in 2020. Details of Stribild's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 27, 2015 |
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2017 |
| New Indication(I-704) | Dec 17, 2017 |
| New Patient Population(NPP) | Jan 27, 2020 |
Several oppositions have been filed on Stribild's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Stribild's generic, the next section provides detailed information on ongoing and past EP oppositions related to Stribild patents.
Stribild's Oppositions Filed in EPO
Stribild has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 13, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04701819A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16180589A | Oct, 2020 | Cooke, Richard | Granted and Under Opposition |
| EP16180589A | Oct, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP16180589A | Jan, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP12167591A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167591A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167589A | May, 2017 | Cooke, Richard | Granted and Under Opposition |
| EP12167589A | May, 2017 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP12167596A | Apr, 2017 | Cooke, Richard | Revoked |
| EP12167596A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP09739981A | Jun, 2016 | Cooke, Richard | Revoked |
| EP09739981A | Jun, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10703766A | Apr, 2016 | Cooke, Richard | Revoked |
| EP10703766A | Apr, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP07836007A | Mar, 2016 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Trösch, Dominique | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Teva Pharmaceutical Industries LTD. | Granted and Under Opposition |
| EP04701819A | Mar, 2009 | Generics [UK] Limited | Revoked |
| EP04701819A | Mar, 2009 | Teva Pharmaceutical Industries LTD. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Stribild 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 Stribild's family patents as well as insights into ongoing legal events on those patents.
Stribild's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Stribild's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Stribild Generics:
There are no approved generic versions for Stribild as of now.
How can I launch a generic of Stribild before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Stribild's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Stribild'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 Stribild -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg/150 mg/ 200 mg/300 mg | 04 Oct, 2018 | 1 | 24 Apr, 2030 |
Alternative Brands for Stribild
Stribild which is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase., has several other brand drugs in the same treatment category . 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 |
| |||||||||||||||
| Bristol |
| |||||||||||||||
| Bristol Myers Squibb |
| |||||||||||||||
| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
| |||||||||||||||
| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||
About Stribild
Stribild is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase. Stribild uses Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate as an active ingredient. Stribild was launched by Gilead Sciences Inc in 2012.
Approval Date:
Stribild was approved by FDA for market use on 27 August, 2012.
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 Stribild is 27 August, 2012, its NCE-1 date is estimated to be 27 August, 2016.
Active Ingredient:
Stribild uses Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate ingredient
Treatment:
Stribild is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Dosage:
Stribild is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG;150MG;200MG;300MG | TABLET | Prescription | ORAL |