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Last Updated: October 22, 2020

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GILEAD SCIENCES INC Company Profile

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Summary for GILEAD SCIENCES INC
International Patents:1833
US Patents:77
Tradenames:16
Ingredients:16
NDAs:19
Drug Master File Entries: 7

Drugs and US Patents for GILEAD SCIENCES INC

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 HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No 8,273,341*PED   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 9,284,342*PED   Start Trial Y   Start Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Start Trial   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 10,456,414   Start Trial Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes 8,754,065   Start Trial Y Y   Start 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 SCIENCES INC

Paragraph IV (Patent) Challenges for GILEAD SCIENCES INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 150 mg, 200 mg, and 250 mg ➤ Subscribe 2012-05-17
➤ Subscribe Tablets 150 mg, 150 mg, 200 mg, 300 mg ➤ Subscribe 2018-10-04
➤ 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

Supplementary Protection Certificates for GILEAD SCIENCES INC Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 C20170001 00217 Estonia   Start Trial PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2203462 CA 2014 00061 Denmark   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
1419152 C 2012 015 Romania   Start Trial PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128
0253412 63/1997 Austria   Start Trial PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: K (97) 1176 19970423
2487162 61/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
McKinsey
Mallinckrodt
Colorcon
Johnson and Johnson

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