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Gilead Sciences Inc Company Profile
What is the competitive landscape for GILEAD SCIENCES INC, and when can generic versions of GILEAD SCIENCES INC drugs launch?
There are sixty-seven US patents protecting GILEAD SCIENCES INC drugs.
There are one thousand five hundred and twenty-two patent family members on GILEAD SCIENCES INC drugs in sixty-eight countries and one hundred and eighty-five supplementary protection certificates in sixteen countries.
Summary for Gilead Sciences Inc
| International Patents: | 1522 |
| US Patents: | 67 |
| Tradenames: | 16 |
| Ingredients: | 16 |
| NDAs: | 17 |
| Drug Master File Entries: | 7 |
| Patent Litigation for Gilead Sciences Inc: | See patent lawsuits for Gilead Sciences Inc |
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 | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | 8,754,065 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | RX | Yes | Yes | 8,754,065 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | Jan 18, 2012 | AB | RX | Yes | No | 5,922,695*PED | ➤ Sign Up | ➤ Sign Up | |||
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | Jan 18, 2012 | RX | Yes | Yes | 5,922,695*PED | ➤ Sign Up | ➤ Sign Up | ||||
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | 6,043,230*PED | ➤ Sign Up |
| Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | 5,914,331*PED | ➤ Sign Up |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | 4,808,716 | ➤ Sign Up |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | 5,922,695*PED | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GILEAD SCIENCES INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 300 mg | ➤ Subscribe | 2010-01-26 |
| ➤ Subscribe | Tablets | 200 mg/25 mg/300 mg | ➤ Subscribe | 2015-05-20 |
| ➤ Subscribe | Tablets | 150 mg, 200 mg, and 250 mg | ➤ Subscribe | 2012-05-17 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2015-12-09 |
Non-Orange Book US Patents for Gilead Sciences Inc
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,069,252 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ➤ Sign Up |
| 8,993,583 | 5-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta | ➤ Sign Up |
| 7,402,588 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane | ➤ Sign Up |
| 5,700,937 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Gilead Sciences Inc Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2016053096 | ➤ Sign Up |
| Philippines | 12014502771 | ➤ Sign Up |
| New Zealand | 540728 | ➤ Sign Up |
| African Regional IP Organization (ARIPO) | 1610 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Gilead Sciences Inc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2017 00002 | Denmark | ➤ Sign Up | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121 |
| 2016000110 | Germany | ➤ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 16004 | Norway | ➤ Sign Up | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203 |
| 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.
