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-five US patents protecting GILEAD drugs.
There are two thousand three hundred and twenty-four 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: | 2324 |
| US Patents: | 85 |
| 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 | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | AB | RX | Yes | No | 9,549,926 | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Gilead Sciences Inc | STRIBILD | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203100-001 | Aug 27, 2012 | RX | Yes | Yes | 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 | 7,390,791*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187-001 | Jun 10, 2021 | RX | Yes | No | 8,334,270*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 | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | 5,977,089*PED | ⤷ Try a Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | 7,427,633 | ⤷ Try a Trial |
| Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | 6,642,245*PED | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | 5,977,089*PED | ⤷ Try a Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | 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 | 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 |
| ➤ 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 |
International Patents for Gilead Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 3067358 | ⤷ Try a Trial |
| Japan | 2015078241 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2013134288 | ⤷ Try a Trial |
| Colombia | 6930366 | ⤷ Try a Trial |
| Japan | 2014088441 | ⤷ 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 |
|---|---|---|---|---|
| 1419152 | 92001 | Luxembourg | ⤷ Try a Trial | 92001, EXPIRES: 20261128 |
| 1761540 | 132017000031007 | Italy | ⤷ Try a Trial | PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919 |
| 2595980 | C02595980/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020 |
| 1663240 | 2015/052 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 0513200 | C00513200/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004 |
| >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.
