Gilead Company Profile
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What is the competitive landscape for GILEAD, and when can generic versions of GILEAD drugs launch?
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 | EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187-002 | Jun 10, 2021 | RX | Yes | Yes | 8,580,765*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477-002 | Aug 28, 2019 | RX | Yes | Yes | 9,511,056*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | 7,635,704*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | 8,865,730 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | 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 | 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 |
| >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 |
|---|---|---|
| Australia | 2017273851 | ⤷ Try a Trial |
| Hungary | 231274 | ⤷ Try a Trial |
| Hong Kong | 1164737 | ⤷ Try a Trial |
| South Africa | 201200310 | ⤷ Try a Trial |
| Chile | 2017001040 | ⤷ 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 |
|---|---|---|---|---|
| 1564210 | PA2013018 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524 |
| 1301519 | 300803 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123 |
| 1419152 | SPC/GB12/025 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE.; REGISTERED: UK EU/1/11/737/001 20111128 |
| 3347352 | CR 2022 00052 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819 |
| 1419152 | C 2012 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
| >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.
