Stribild Patent Expiration

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, 10 months from now)

Active
US8981103 Stable crystal of 4-oxoquinoline compound
Oct, 2026

(1 year, 10 months from now)

Active
US7176220 4-oxoquinoline compound and use thereof as pharmaceutical agent
Aug, 2026

(1 year, 8 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

(8 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

(5 years from now)

Active
US9891239

(Pediatric)

Modulators of pharmacokinetic properties of therapeutics
Mar, 2030

(5 years from now)

Active
US8148374

(Pediatric)

Modulators of pharmacokinetic properties of therapeutics
Mar, 2030

(5 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

(2 years from now)

Active
US7635704

(Pediatric)

Stable crystal of 4-oxoquinoline compound
Apr, 2027

(2 years from now)

Active
US7176220

(Pediatric)

4-oxoquinoline compound and use thereof as pharmaceutical agent
Feb, 2027

(2 years from now)

Active
US8716264

(Pediatric)

Compositions and methods for combination antiviral therapy
Jul, 2024

(5 months ago)

Expired
US8716264 Compositions and methods for combination antiviral therapy
Jan, 2024

(10 months ago)

Expired
US8592397 Compositions and methods for combination antiviral therapy
Jan, 2024

(10 months ago)

Expired
US9457036 Compositions and methods for combination antiviral therapy
Jan, 2024

(10 months ago)

Expired
US9744181 Compositions and methods for combination antiviral therapy
Jan, 2024

(10 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

(3 years ago)

Expired
US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 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

(6 years ago)

Expired
US5977089

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US6043230

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US5935946

(Pediatric)

Nucleotide analog composition and synthesis method
Jan, 2018

(6 years ago)

Expired
US5914331

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jan, 2018

(6 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

(8 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.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Stribild has patent protection in a total of 48 countries. It's US patent count contributes only to 14.2% of its total global patent coverage. 7 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Stribild.

Family Patents

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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
Kaletra used for treating HIV-1 infection in combination with other antiretroviral agents.
Agouron Pharms
Viracept Used for managing HIV infection.
Bristol
Evotaz Used for treating HIV-1 infection by including a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase.
Bristol Myers Squibb
Sustiva used for managing HIV infection in combination with other antiviral drugs.
Gilead
Emtriva Used for treating HIV infection in adults.
Truvada Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Tybost Used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
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.
Glaxosmithkline
Agenerase Used for managing HIV infection.
Msd Sub Merck
Isentress Used for treating HIV infection by inhibiting integrase.
Isentress Hd Used for treating HIV infection.
Viiv Hlthcare
Dovato Used for the treatment of HIV infection.
Juluca Used for managing HIV infection.
Lexiva Used for managing and treating HIV infection.
Epzicom Used for treating HIV infection.





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