Register entry
Organon LLC
- Registered sites
- 4
- Drug products
- 92
- Live patents
- 19
- Countries
- 4
- Base
- Netherlands
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
4| Site | Location | Operations | FEI |
|---|---|---|---|
| Organon Heist | Heist-op-den-BergBelgium | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3003974846 |
| ORGANON PHARMA (UK) LIMITED | NorthumberlandUnited Kingdom | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002807653 |
| Organon Pharma Mexico, S.A. de C.V. | XochimilcoMexico | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3022529610 |
| N.V. Organon | OssNetherlands | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3002806821 |
Exclusivity
Patents
19Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| IMPLANON | ETONOGESTREL | Jul 2030 |
| NEXPLANON | ETONOGESTREL | Aug 2026 |
| NEXPLANON | ETONOGESTREL | May 2027 |
| NEXPLANON | ETONOGESTREL | Sept 2027 |
| NEXPLANON | ETONOGESTREL | Jul 2030 |
| VTAMA | TAPINAROF | May 2036 |
| VTAMA | TAPINAROF | May 2036 |
| VTAMA | TAPINAROF | Nov 2038 |
| VTAMA | TAPINAROF | Nov 2039 |
| VTAMA | TAPINAROF | Dec 2039 |
| XACIATO | CLINDAMYCIN PHOSPHATE | Sept 2036 |
Catalogue
Marketed products
92Showing 92 of 92.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ASMANEX | Mometasone Furoate | INHALANT | NDA |
| ASMANEX | Mometasone Furoate | INHALANT | NDA |
| ASMANEX HFA | MOMETASONE FUROATE | AEROSOL | NDA |
| ASMANEX HFA | MOMETASONE FUROATE | AEROSOL | NDA |
| ASMANEX HFA | MOMETASONE FUROATE | AEROSOL | NDA |
| CELESTONE SOLUSPAN | Betamethasone Acetate and Betamethasone Sodium Phosphate | INJECTION, SUSPENSION | NDA |
| CLARINEX-D 12 HOUR | desloratadine and pseudoephedrine sulfate | TABLET, EXTENDED RELEASE | NDA |
| COZAAR | losartan potassium | TABLET, FILM COATED | NDA |
| COZAAR | losartan potassium | TABLET, FILM COATED | NDA |
| COZAAR | losartan potassium | TABLET, FILM COATED | NDA |
| Clarinex | Desloratadine | TABLET, FILM COATED | NDA |
| Clarinex | Desloratadine | TABLET, FILM COATED | NDA |
| DIPROLENE | betamethasone dipropionate | OINTMENT | NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | AEROSOL | NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | AEROSOL | NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | AEROSOL | NDA |
| FOSAMAX | alendronate sodium | TABLET | NDA |
| FOSAMAX PLUS D | ALENDRONATE SODIUM and CHOLECALCIFEROL | TABLET | NDA |
| FOSAMAX PLUS D | ALENDRONATE SODIUM and CHOLECALCIFEROL | TABLET | NDA |
| Follistim AQ | follitropin | INJECTION, SOLUTION | BLA |
| Follistim AQ | follitropin | INJECTION, SOLUTION | BLA |
| Follistim AQ | follitropin | INJECTION, SOLUTION | BLA |
| Ganirelix Acetate | Ganirelix Acetate | INJECTION, SOLUTION | NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | NDA |
| Hadlima | adalimumab-bwwd | SOLUTION | BLA |
| Hadlima | adalimumab-bwwd | SOLUTION | BLA |
| Hadlima | adalimumab-bwwd | SOLUTION | BLA |
| Hadlima | adalimumab-bwwd | SOLUTION | BLA |
| Hadlima | adalimumab-bwwd | SOLUTION | BLA |
| MAXALT | rizatriptan benzoate | TABLET | NDA |
| MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING | NDA |
| - | MIRTAZAPINE | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | MIRTAZAPINE | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| Miudella | Copper | INTRAUTERINE DEVICE | NDA |
| Nexplanon | etonogestrel | IMPLANT | NDA |
| NuvaRing | etonogestrel and ethinyl estradiol | INSERT, EXTENDED RELEASE | NDA |
| Ontruzant | trastuzumab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Ontruzant | Ontruzant | KIT | BLA |
| PROPECIA | finasteride | TABLET, FILM COATED | NDA |
| PROSCAR | FINASTERIDE | TABLET, FILM COATED | NDA |
| Pregnyl | CHORIOGONADOTROPIN ALFA | KIT | BLA |
| REMERON | MIRTAZAPINE | TABLET, FILM COATED | NDA |
| REMERON | MIRTAZAPINE | TABLET, FILM COATED | NDA |
| REMERONSOLTAB | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING | NDA |
| REMERONSOLTAB | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING | NDA |
| REMERONSOLTAB | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING | NDA |
| - | SIMVASTATIN | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | SIMVASTATIN | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | SIMVASTATIN | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| SINEMET | carbidopa and levodopa | TABLET | NDA |
| SINEMET | carbidopa and levodopa | TABLET | NDA |
| SINEMET | carbidopa and levodopa | TABLET | NDA |
| SINEMET | carbidopa and levodopa | TABLET | NDA |
| SINGULAIR | montelukast sodium | TABLET, CHEWABLE | NDA |
| SINGULAIR | montelukast sodium | GRANULE | NDA |
| SINGULAIR | montelukast sodium | TABLET, FILM COATED | NDA |
| SINGULAIR | montelukast sodium | TABLET, CHEWABLE | NDA |
| - | SUGAMMADEX SODIUM | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | TABLET | DRUG FOR FURTHER PROCESSING |
| TOFIDENCE | TOCILIZUMAB | INJECTION | BLA |
| TOFIDENCE | TOCILIZUMAB | INJECTION | BLA |
| TOFIDENCE | TOCILIZUMAB | INJECTION | BLA |
| VTAMA | tapinarof | CREAM | NDA |
| VYTORIN | ezetimibe and simvastatin | TABLET | NDA |
| VYTORIN | ezetimibe and simvastatin | TABLET | NDA |
| VYTORIN | ezetimibe and simvastatin | TABLET | NDA |
| VYTORIN | ezetimibe and simvastatin | TABLET | NDA |
| XACIATO | clindamycin phosphate | GEL | NDA |
| ZOCOR | SIMVASTATIN | TABLET, FILM COATED | NDA |
| ZOCOR | SIMVASTATIN | TABLET, FILM COATED | NDA |
| ZOCOR | SIMVASTATIN | TABLET, FILM COATED | NDA |
| Zetia | Ezetimibe | TABLET | NDA |
| - | etonogestrel and ethinyl estradiol | INSERT, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | TABLET | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | TABLET, CHEWABLE | DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | TABLET, CHEWABLE | DRUG FOR FURTHER PROCESSING |
| - | posaconazole | TABLET, COATED | DRUG FOR FURTHER PROCESSING |
| - | posaconazole | GRANULE | DRUG FOR FURTHER PROCESSING |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.