Gilead Company Profile
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What is the competitive landscape for GILEAD, and what generic alternatives to GILEAD drugs are available?
GILEAD has thirty approved drugs.
There are eighty-eight US patents protecting GILEAD drugs.
There are two thousand three hundred and twenty-three patent family members on GILEAD drugs in sixty-six countries and three hundred and ninety-seven supplementary protection certificates in nineteen countries.
Summary for Gilead
| International Patents: | 2323 |
| US Patents: | 88 |
| Tradenames: | 24 |
| Ingredients: | 24 |
| NDAs: | 30 |
| Patent Litigation for Gilead: | See patent lawsuits for Gilead |
| PTAB Cases with Gilead as patent owner: | See PTAB cases with Gilead as patent owner |
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 | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | 11,116,783*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | 10,039,779*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187-001 | Jun 10, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | 7,176,220*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ 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 | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | 6,642,245*PED | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | 4,808,716 | ⤷ Try a Trial |
| Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | 7,601,730 | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | 6,642,245*PED | ⤷ Try a Trial |
| Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | 6,838,464 | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | Jan 18, 2012 | 5,977,089*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 | 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 |
| ➤ Subscribe | Tablets | 150 mg, 150 mg, 200 mg, 300 mg | ➤ Subscribe | 2018-10-04 |
International Patents for Gilead Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20150043553 | ⤷ Try a Trial |
| Norway | 2017066 | ⤷ Try a Trial |
| Israel | 216492 | ⤷ Try a Trial |
| Lithuania | C3150586 | ⤷ Try a Trial |
| European Patent Office | 1636190 | ⤷ Try a Trial |
| Ecuador | SP14013206 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Gilead Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663240 | PA2015035,C1663240 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128 |
| 2487163 | 2017002 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810 |
| 1663240 | 132016000024787 | Italy | ⤷ Try a Trial | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
| 0915894 | SPC/GB05/041 | United Kingdom | ⤷ Try a Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020. |
| 3808743 | CA 2022 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
| 2430014 | CR 2016 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118 |
| >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.
Here is a list of applicants with similar names.
