Register entry
- Registered sites
- 4
- Active NDC listings
- 51
- Labeller names
- 2
- Live patents
- 530
- Exclusivities
- 10
- Shortage listings
- 5
- Countries
- 3
- Base
- United States
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Gilead Alberta ULCRegistrant: Gilead Sciences, Inc. | 1021 Hayter Rd NW, Edmonton, Alberta T6S 1A1, Canada (CAN) | Analytical testing, Active ingredient (API) manufacture | 3001027806207452996 |
| GILEAD SCIENCES IRELAND UNLIMITED COMPANYRegistrant: Gilead Sciences, Inc. | IDA Business & Technology Park, Carrigtohill, Cork T45 DP77, Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3006709727989325600 |
| Gilead Sciences, Inc. | 333 Lakeside Dr, Foster City, California (CA) 94404, United States (USA) | Analytical testing | 1000523075185049848 |
| Gilead Sciences, Inc. | 1800 Wheeler Ave, La Verne, California (CA) 91750, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3013189568080552061 |
Alert
Drug shortage listings
5| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Emtricitabine CapsuleAnti-Infective | Emtriva, Capsule, 200 mg (NDC 61958-0601-1) | To Be Discontinued | - | 17 Jun 202617 Jun 2026 |
| Emtricitabine Oral SolutionAnti-Infective | Emtriva, Oral Solution, 10 mg/1 mL (NDC 61958-0602-1) | To Be Discontinued | - | 17 Jun 202617 Jun 2026 |
| Idelalisib TabletOncology | Zydelig, Tablet, 100 mg (NDC 61958-1701-1) | To Be Discontinued | - | 7 Apr 20267 Apr 2026 |
| Idelalisib TabletOncology | Zydelig, Tablet, 150 mg (NDC 61958-1702-1) | To Be Discontinued | - | 7 Apr 20267 Apr 2026 |
| Cobicistat TabletAntiviral | Tybost, Tablet, 150 mg (NDC 61958-1401-1) | To Be Discontinued | - | 7 Oct 20257 Oct 2025 |
Catalogue
Drug listings by form and route
5151 active NDC listings: 50 human prescription drug, 1 bulk ingredient. By marketing category: NDA 48, BLA 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 21 |
| tablet | 8 |
| pellet | 6 |
| kit | 4 |
| tablet, coated | 4 |
| capsule | 2 |
| injection, powder, lyophilized, for solution | 2 |
| powder | 2 |
| powder, for solution | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| oral | 43 |
| intravenous | 2 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| gilead sciences, inc. | 42 |
| gilead sciences, inc | 9 |
Exclusivity
Patents and exclusivities
530| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7635704 | GENVOYA, STRIBILD, VITEKTAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate; elvitegravir | substance, product | Oct 2026 |
| 8981103 | GENVOYA, STRIBILD, VITEKTAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate; elvitegravir | substance, product | Oct 2026 |
| 7176220*PED | GENVOYA, STRIBILD, VITEKTAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate; elvitegravir | use | Feb 2027 |
| 7635704*PED | GENVOYA, STRIBILD, VITEKTAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate; elvitegravir | use | Apr 2027 |
| 8981103*PED | GENVOYA, STRIBILD, VITEKTAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate; elvitegravir | use | Apr 2027 |
| 7301050 | LIVDELZIseladelpar lysine | substance, product | Aug 2027 |
| 7709682 | LIVDELZIseladelpar lysine | substance | Sept 2027 |
| 8377933 | LETAIRISambrisentan | use | Dec 2027 |
| 9474752 | LETAIRISambrisentan | use | Dec 2027 |
| 8334270 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2028 |
| 8580765 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2028 |
| 8735372 | EPCLUSA, HARVONI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2028 |
| 8957046 | VOSEVIsofosbuvir; velpatasvir; voxilaprevir | use | Mar 2028 |
| 9085573 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2028 |
| 8334270*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2028 |
| 8580765*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2028 |
| 8735372*PED | EPCLUSA, HARVONI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2028 |
| 9085573*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2028 |
| 7964580 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2029 |
| 8633309 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2029 |
| 8889159 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Mar 2029 |
| 9549941 | SOVALDIsofosbuvir | use | Mar 2029 |
| 8318682 | VEKLURYremdesivir | substance, product | Apr 2029 |
| RE46762 | VEKLURYremdesivir | substance, product | Apr 2029 |
| 8598185 | ATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarate | product | Apr 2029 |
| 8148374 | GENVOYA, STRIBILD, TYBOSTcobicistat; cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | substance, product | Sept 2029 |
| 9891239 | GENVOYA, STRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | product | Sept 2029 |
| 8008264 | VEKLURYremdesivir | substance, product | Sept 2029 |
| 7964580*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2029 |
| 8633309*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2029 |
| 8889159*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Sept 2029 |
| 9549941*PED | SOVALDIsofosbuvir | use | Sept 2029 |
| 8318682*PED | VEKLURYremdesivir | use | Oct 2029 |
| RE46762*PED | VEKLURYremdesivir | use | Oct 2029 |
| 8148374*PED | GENVOYA, STRIBILD, TYBOSTcobicistat; cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | use | Mar 2030 |
| 9891239*PED | GENVOYA, STRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | use | Mar 2030 |
| 8008264*PED | VEKLURYremdesivir | use | Mar 2030 |
| 9492449 | ZYDELIGidelalisib | use | Mar 2030 |
| 8633219 | GENVOYA, STRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | product | Apr 2030 |
| 8088368 | HARVONIledipasvir; sofosbuvir | substance, product | May 2030 |
| 8273341 | HARVONIledipasvir; sofosbuvir | use | May 2030 |
| 8822430 | HARVONIledipasvir; sofosbuvir | substance, product | May 2030 |
| 8841278 | HARVONIledipasvir; sofosbuvir | product | May 2030 |
| 9511056 | HARVONIledipasvir; sofosbuvir | product | May 2030 |
| 9284342 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Sept 2030 |
| 8633219*PED | GENVOYA, STRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | use | Oct 2030 |
| 8088368*PED | HARVONIledipasvir; sofosbuvir | use | Nov 2030 |
| 8273341*PED | HARVONIledipasvir; sofosbuvir | use | Nov 2030 |
| 8822430*PED | HARVONIledipasvir; sofosbuvir | use | Nov 2030 |
| 8841278*PED | HARVONIledipasvir; sofosbuvir | use | Nov 2030 |
| 9511056*PED | HARVONIledipasvir; sofosbuvir | use | Nov 2030 |
| 8618076 | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | substance, product | Dec 2030 |
| 9284342*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Mar 2031 |
| 8618076*PED | EPCLUSA, HARVONI, SOVALDI, VOSEVIledipasvir; sofosbuvir; sofosbuvir; sofosbuvir; velpatasvir; sofosbuvir; velpatasvir; voxilaprevir | use | Jun 2031 |
| 9549926 | LETAIRISambrisentan | use | Oct 2031 |
| 11492353 | VEKLURYremdesivir | substance | Dec 2031 |
| 11492353*PED | VEKLURYremdesivir | use | Jun 2032 |
| 8754065 | BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, VEMLIDYbictegravir sodium; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate; emtricitabine; tenofovir alafenamide fumarate; tenofovir alafenamide fumarate | substance, product | Aug 2032 |
| 9296769 | BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, VEMLIDYbictegravir sodium; emtricitabine; tenofovir alafenamide fumarate; cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate; emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate; emtricitabine; tenofovir alafenamide fumarate; tenofovir alafenamide fumarate | substance, product | Aug 2032 |
| 10456414 | HARVONIledipasvir; sofosbuvir | product | Sept 2032 |
| Product | Exclusivity | Until |
|---|---|---|
| BIKTARVYBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | ODE-540 Orphan drug | Jul 2032 |
| DESCOVYEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | ODE-556 Orphan drug | Jun 2032 |
| EPCLUSASOFOSBUVIR; VELPATASVIR | PED Paediatric | Dec 2028 |
| LIVDELZISELADELPAR LYSINE | ODE-486 Orphan drug | Aug 2031 |
| SUNLENCALENACAPAVIR SODIUM | NCE New chemical entity | Dec 2027 |
| TYBOSTCOBICISTAT | NPP New patient population | Jun 2028 |
| TYBOSTCOBICISTAT | NS New strength | Jun 2028 |
| VEKLURYREMDESIVIR | PED Paediatric | Aug 2027 |
| VEMLIDYTENOFOVIR ALAFENAMIDE FUMARATE | NPP New patient population | Mar 2027 |
| YEZTUGOLENACAPAVIR SODIUM | NP New product | Jun 2028 |
Catalogue
Marketed products
51| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AZTREONAM | powder | 24525-0025BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| BIXLENVO | bictegravir/lenacapavir | tablet, film coated, oral | 61958-3601NDA |
| Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | tablet, oral | 61958-2501NDA |
| Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | tablet, oral | 61958-2505NDA |
| Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | tablet, oral | 61958-2506NDA |
| COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-1101NDA |
| Cayston | aztreonam | kit | 61958-0901NDA |
| DESCOVY | emtricitabine and tenofovir alafenamide | tablet, oral | 61958-2002NDA |
| DESCOVY | emtricitabine and tenofovir alafenamide | tablet, oral | 61958-2005NDA |
| Emtriva | EMTRICITABINE | capsule, oral | 61958-0601NDA |
| Emtriva | EMTRICITABINE | solution, oral | 61958-0602NDA |
| Epclusa | Velpatasvir and Sofosbuvir | tablet, film coated, oral | 61958-2201NDA |
| Epclusa | Velpatasvir and Sofosbuvir | tablet, film coated, oral | 61958-2203NDA |
| Epclusa | Velpatasvir and Sofosbuvir | pellet, oral | 61958-2204NDA |
| Epclusa | Velpatasvir and Sofosbuvir | pellet, oral | 61958-2205NDA |
| Genvoya | elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | tablet, oral | 61958-1901NDA |
| HEPCLUDEX | BULEVIRTIDE | injection, powder, lyophilized, for solution, subcutaneous | 61958-3104BLA |
| Harvoni | LEDIPASVIR and SOFOSBUVIR | tablet, film coated, oral | 61958-1801NDA |
| Harvoni | ledipasvir and sofosbuvir | tablet, film coated, oral | 61958-1803NDA |
| Harvoni | ledipasvir and sofosbuvir | pellet, oral | 61958-1804NDA |
| Harvoni | ledipasvir and sofosbuvir | pellet, oral | 61958-1805NDA |
| Letairis | AMBRISENTAN | tablet, film coated, oral | 61958-0801NDA |
| Letairis | AMBRISENTAN | tablet, film coated, oral | 61958-0802NDA |
| Livdelzi | SELADELPAR LYSINE | capsule, oral | 61958-3301NDA |
| ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | tablet, oral | 61958-2101NDA |
| Sovaldi | SOFOSBUVIR | tablet, film coated, oral | 61958-1501NDA |
| Sovaldi | SOFOSBUVIR | tablet, film coated, oral | 61958-1503NDA |
| Sovaldi | SOFOSBUVIR | pellet, oral | 61958-1504NDA |
| Sovaldi | SOFOSBUVIR | pellet, oral | 61958-1505NDA |
| Stribild | elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-1201NDA |
| Sunlenca | LENACAPAVIR SODIUM | tablet, film coated, oral | 61958-3001NDA |
| Sunlenca | LENACAPAVIR SODIUM | kit | 61958-3002NDA |
| Sunlenca | LENACAPAVIR SODIUM | kit | 61958-3005NDA |
| TRODELVY | SACITUZUMAB GOVITECAN | powder, for solution, intravenous | 55135-132BLA |
| Truvada | emtricitabine and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-0701NDA |
| Truvada | emtricitabine and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-0703NDA |
| Truvada | emtricitabine and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-0704NDA |
| Truvada | emtricitabine and tenofovir disoproxil fumarate | tablet, film coated, oral | 61958-0705NDA |
| Tybost | COBICISTAT | tablet, film coated, oral | 61958-1401NDA |
| VEMLIDY | tenofovir alafenamide | tablet, oral | 61958-2301NDA |
| Veklury | remdesivir | injection, powder, lyophilized, for solution, intravenous | 61958-2901NDA |
| Viread | TENOFOVIR DISOPROXIL FUMARATE | tablet, coated, oral | 61958-0401NDA |
| Viread | TENOFOVIR DISOPROXIL FUMARATE | powder, oral | 61958-0403NDA |
| Viread | TENOFOVIR DISOPROXIL FUMARATE | tablet, coated, oral | 61958-0404NDA |
| Viread | TENOFOVIR DISOPROXIL FUMARATE | tablet, coated, oral | 61958-0405NDA |
| Viread | TENOFOVIR DISOPROXIL FUMARATE | tablet, coated, oral | 61958-0406NDA |
| Vosevi | SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR | tablet, film coated, oral | 61958-2401NDA |
| Yeztugo | LENACAPAVIR SODIUM | tablet, film coated, oral | 61958-3401NDA |
| Yeztugo | LENACAPAVIR SODIUM | kit | 61958-3402NDA |
| Zydelig | idelalisib | tablet, film coated, oral | 61958-1701NDA |
| Zydelig | idelalisib | tablet, film coated, oral | 61958-1702NDA |
Neighbours
Registered in the same town
3- GE Healthcare Inc.Carrigtohill, IRL
- Geron CorporationFoster City, CA
- Prostat First Aid, LLCLa Verne, CA
Compare
Comparable companies in United States
- Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
- Church & Dwight Co., Inc.4 sites · 157 NDC
- Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
- Bausch & Lomb Ireland Limited4 sites · 92 NDC
- Grifols Therapeutics LLC4 sites · 53 NDC
- Nice-Pak Products, LLC4 sites · 48 NDC
- HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
- Pacific Medical Industries Ltd4 sites · 41 NDC
- United Therapeutics Corporation4 sites · 40 NDC
- Avantor Performance Materials, LLC4 sites · 33 NDC
Enquiry
Common questions
- Is Gilead Sciences, Inc. FDA approved?
- Gilead Sciences, Inc. holds 4 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Gilead Sciences, Inc.'s drugs manufactured?
- At registered sites in Canada, Ireland, the United States. The FDA register lists Edmonton; Carrigtohill; Foster City, CA; La Verne, CA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Gilead Sciences, Inc. make?
- 51 products are listed under Gilead Sciences, Inc. in the openFDA NDC Directory, most often as tablet, film coated; tablet; pellet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.