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Last Updated: May 1, 2024

Gilead Company Profile


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Summary for Gilead

Drugs and US Patents for Gilead

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No 10,086,011*PED ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 8,822,430*PED ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes 9,457,036 ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-001 Aug 28, 2019 RX Yes No 8,889,159*PED ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes 8,921,341*PED ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes 10,039,779*PED ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Gilead

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 5,914,331*PED ⤷  Try a Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 6,703,396*PED ⤷  Try a Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 5,922,695*PED ⤷  Try a Trial
Gilead Sciences Inc VISTIDE cidofovir INJECTABLE;INJECTION 020638-001 Jun 26, 1996 5,142,051 ⤷  Try a Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 5,922,695*PED ⤷  Try a Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 6,703,396*PED ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GILEAD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 150 mg, 150 mg, 200 mg, 300 mg ➤ Subscribe 2018-10-04
➤ Subscribe Capsules 200 mg ➤ Subscribe 2012-07-16
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2015-02-09
➤ Subscribe Tablets 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg ➤ Subscribe 2017-05-19
➤ Subscribe Tablets 300 mg ➤ Subscribe 2010-01-26
➤ Subscribe Tablets 200 mg/25 mg/300 mg ➤ Subscribe 2015-05-20
➤ Subscribe Tablets 150 mg ➤ Subscribe 2015-12-09
➤ Subscribe Tablets 10 mg ➤ Subscribe 2010-06-08
➤ Subscribe Tablets 200 mg/300 mg ➤ Subscribe 2008-09-26
➤ Subscribe Tablets 600 mg/200 mg/300 mg ➤ Subscribe 2008-12-29
➤ Subscribe Tablets 150 mg, 200 mg, and 250 mg ➤ Subscribe 2012-05-17

Supplementary Protection Certificates for Gilead Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 C201530064 Spain ⤷  Try a Trial PRODUCT NAME: COBICISTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/13/830; DATE OF AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830; DATE OF FIRST AUTHORISATION IN EEA: 20130524
2203462 300704 Netherlands ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
0785926 08C0041 France ⤷  Try a Trial PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
1419152 CR 2012 00021 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2822954 2018026 Norway ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER/DATE: NO, EU/1/18/1289, BIKTARVY, 20180625
3150586 2020C/515 Belgium ⤷  Try a Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.