List of Excipients in API SIMVASTATIN
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Excipients in NDA-approved (novel) drugs containing SIMVASTATIN
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | ASCORBIC ACID | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | BUTYLATED HYDROXYANISOLE | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | CELLULOSE, MICROCRYSTALLINE | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | CITRIC ACID MONOHYDRATE | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | FERRIC OXIDE RED | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | HYDROXYPROPYL CELLULOSE | |
| Merck Sharp & Dohme Corp | ZOCOR | simvastatin | 0006-0543 | HYPROMELLOSE 2910 | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing SIMVASTATIN
Detailed excipient profiles for SIMVASTATIN
Excipient focus: ACESULFAME POTASSIUM
SIMVASTATIN drug variants containing ACESULFAME POTASSIUM
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing ACESULFAME POTASSIUM
Excipient focus: ALCOHOL
SIMVASTATIN drug variants containing ALCOHOL
SIMVASTATIN drug variants not containing ALCOHOL
Excipient focus: ANHYDROUS CITRIC ACID
SIMVASTATIN drug variants containing ANHYDROUS CITRIC ACID
SIMVASTATIN drug variants not containing ANHYDROUS CITRIC ACID
Excipient focus: ANHYDROUS LACTOSE
SIMVASTATIN drug variants containing ANHYDROUS LACTOSE
| Company | Ingredient | NDC |
|---|---|---|
| Blenheim Pharmacal Inc | simvastatin | 10544-486 |
| State of Florida DOH Central Pharmacy | simvastatin | 53808-0800 |
| Zydus Lifesciences Limited | simvastatin | 65841-065 |
| Contract Pharmacy Services-PA | simvastatin | 67046-672 |
| Zydus Pharmaceuticals USA Inc | simvastatin | 68382-065 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing ANHYDROUS LACTOSE
Excipient focus: ASCORBIC ACID
SIMVASTATIN drug variants containing ASCORBIC ACID
SIMVASTATIN drug variants not containing ASCORBIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| Physicians Total Care Inc | simvastatin and niacin | 54868-5886 |
| >Company | >Ingredient | >NDC |
Excipient focus: BHA
SIMVASTATIN drug variants containing BHA
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-4801 |
| A-S Medication Solutions | simvastatin | 50090-5019 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing BHA
Excipient focus: BUTYLATED HYDROXYANISOLE
SIMVASTATIN drug variants containing BUTYLATED HYDROXYANISOLE
SIMVASTATIN drug variants not containing BUTYLATED HYDROXYANISOLE
Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM
SIMVASTATIN drug variants containing CARBOXYMETHYLCELLULOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CARBOXYMETHYLCELLULOSE SODIUM
Excipient focus: CELLULOSE, MICROCRYSTALLINE
SIMVASTATIN drug variants containing CELLULOSE, MICROCRYSTALLINE
SIMVASTATIN drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: CI 77491
SIMVASTATIN drug variants containing CI 77491
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-6420 |
| A-S Medication Solutions | simvastatin | 50090-6421 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CI 77491
Excipient focus: CI 77492
SIMVASTATIN drug variants containing CI 77492
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-4801 |
| A-S Medication Solutions | simvastatin | 50090-5019 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CI 77492
Excipient focus: CI 77891
SIMVASTATIN drug variants containing CI 77891
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-6420 |
| A-S Medication Solutions | simvastatin | 50090-6421 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CI 77891
Excipient focus: CITRIC ACID
SIMVASTATIN drug variants containing CITRIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-0999 |
| A-S Medication Solutions | simvastatin | 50090-4801 |
| A-S Medication Solutions | simvastatin | 50090-5019 |
| A-S Medication Solutions | simvastatin | 50090-6420 |
| A-S Medication Solutions | simvastatin | 50090-6421 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CITRIC ACID
Excipient focus: CITRIC ACID ANHYDROUS
SIMVASTATIN drug variants containing CITRIC ACID ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| Contract Pharmacy Services-PA | simvastatin | 67046-672 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CITRIC ACID ANHYDROUS
Excipient focus: CITRIC ACID MONOHYDRATE
SIMVASTATIN drug variants containing CITRIC ACID MONOHYDRATE
SIMVASTATIN drug variants not containing CITRIC ACID MONOHYDRATE
Excipient focus: COLLOIDAL SILICON DIOXIDE
SIMVASTATIN drug variants containing COLLOIDAL SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| State of Florida DOH Central Pharmacy | simvastatin | 53808-0927 |
| Biocon Limited | simvastatin | 65727-065 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing COLLOIDAL SILICON DIOXIDE
Excipient focus: CROSCARMELLOSE SODIUM
SIMVASTATIN drug variants containing CROSCARMELLOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Blenheim Pharmacal Inc | simvastatin | 10544-908 |
| Accord Healthcare Inc | simvastatin | 16729-005 |
| Accord Healthcare Inc | simvastatin | 16729-156 |
| Aidarex Pharmaceuticals LLC | simvastatin | 33261-546 |
| RxChange Co | simvastatin | 33358-431 |
| RxChange Co | simvastatin | 33358-475 |
| Rebel Distributors Corp | simvastatin | 42254-129 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: DIMETHICONE
SIMVASTATIN drug variants containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing DIMETHICONE
Excipient focus: ETHYLPARABEN
SIMVASTATIN drug variants containing ETHYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing ETHYLPARABEN
Excipient focus: FD&C BLUE NO. 2
SIMVASTATIN drug variants containing FD&C BLUE NO. 2
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | simvastatin and niacin | 54868-5886 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing FD&C BLUE NO. 2
Excipient focus: FERRIC OXIDE RED
SIMVASTATIN drug variants containing FERRIC OXIDE RED
SIMVASTATIN drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
SIMVASTATIN drug variants containing FERRIC OXIDE YELLOW
SIMVASTATIN drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: FERROSOFERRIC OXIDE
SIMVASTATIN drug variants containing FERROSOFERRIC OXIDE
SIMVASTATIN drug variants not containing FERROSOFERRIC OXIDE
Excipient focus: HEMATITE
SIMVASTATIN drug variants containing HEMATITE
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-4801 |
| A-S Medication Solutions | simvastatin | 50090-5019 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing HEMATITE
Excipient focus: HYDROXYPROPYL CELLULOSE
SIMVASTATIN drug variants containing HYDROXYPROPYL CELLULOSE
SIMVASTATIN drug variants not containing HYDROXYPROPYL CELLULOSE
Excipient focus: HYPROMELLOSE
SIMVASTATIN drug variants containing HYPROMELLOSE
SIMVASTATIN drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2910
SIMVASTATIN drug variants containing HYPROMELLOSE 2910
SIMVASTATIN drug variants not containing HYPROMELLOSE 2910
Excipient focus: HYPROMELLOSES
SIMVASTATIN drug variants containing HYPROMELLOSES
SIMVASTATIN drug variants not containing HYPROMELLOSES
Excipient focus: ISOPROPYL ALCOHOL
SIMVASTATIN drug variants containing ISOPROPYL ALCOHOL
SIMVASTATIN drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: LACTOSE
SIMVASTATIN drug variants containing LACTOSE
| Company | Ingredient | NDC |
|---|---|---|
| Merck Sharp & Dohme Corp | simvastatin | 0006-0543 |
| Organon LLC | simvastatin | 78206-179 |
| Organon LLC | simvastatin | 78206-182 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing LACTOSE
Excipient focus: LACTOSE MONOHYDRATE
SIMVASTATIN drug variants containing LACTOSE MONOHYDRATE
SIMVASTATIN drug variants not containing LACTOSE MONOHYDRATE
Excipient focus: MAGNESIUM ALUMINUM SILICATE
SIMVASTATIN drug variants containing MAGNESIUM ALUMINUM SILICATE
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing MAGNESIUM ALUMINUM SILICATE
Excipient focus: MAGNESIUM STEARATE
SIMVASTATIN drug variants containing MAGNESIUM STEARATE
SIMVASTATIN drug variants not containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| Physicians Total Care Inc | simvastatin and niacin | 54868-5886 |
| >Company | >Ingredient | >NDC |
Excipient focus: MALTODEXTRIN
SIMVASTATIN drug variants containing MALTODEXTRIN
| Company | Ingredient | NDC |
|---|---|---|
| Westminster Pharmaceuticals LLC | simvastatin | 69367-374 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing MALTODEXTRIN
Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES
SIMVASTATIN drug variants containing MEDIUM-CHAIN TRIGLYCERIDES
| Company | Ingredient | NDC |
|---|---|---|
| Westminster Pharmaceuticals LLC | simvastatin | 69367-374 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing MEDIUM-CHAIN TRIGLYCERIDES
Excipient focus: METHYLPARABEN
SIMVASTATIN drug variants containing METHYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing METHYLPARABEN
Excipient focus: POLYDEXTROSE
SIMVASTATIN drug variants containing POLYDEXTROSE
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | simvastatin | 21695-738 |
| Physicians Total Care Inc | simvastatin | 54868-6066 |
| Westminster Pharmaceuticals LLC | simvastatin | 69367-374 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POLYDEXTROSE
Excipient focus: POLYETHYLENE GLYCOL
SIMVASTATIN drug variants containing POLYETHYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | simvastatin | 21695-738 |
| State of Florida DOH Central Pharmacy | simvastatin | 53808-0792 |
| Physicians Total Care Inc | simvastatin and niacin | 54868-5886 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 3350
SIMVASTATIN drug variants containing POLYETHYLENE GLYCOL 3350
| Company | Ingredient | NDC |
|---|---|---|
| QPharma Inc | simvastatin | 42708-051 |
| QPharma Inc | simvastatin | 42708-052 |
| International Laboratories LLC | simvastatin | 54458-934 |
| MedVantx Inc | simvastatin | 66116-316 |
| Carilion Materials Management | simvastatin | 68151-0177 |
| Proficient Rx LP | simvastatin | 71205-070 |
| Bryant Ranch Prepack | simvastatin | 71335-1020 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POLYETHYLENE GLYCOL 3350
Excipient focus: POLYETHYLENE GLYCOL 4000
SIMVASTATIN drug variants containing POLYETHYLENE GLYCOL 4000
| Company | Ingredient | NDC |
|---|---|---|
| QPharma Inc | simvastatin | 42708-051 |
| QPharma Inc | simvastatin | 42708-052 |
| International Laboratories LLC | simvastatin | 54458-934 |
| Carilion Materials Management | simvastatin | 68151-0177 |
| Proficient Rx LP | simvastatin | 71205-070 |
| Bryant Ranch Prepack | simvastatin | 71335-1020 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POLYETHYLENE GLYCOL 4000
Excipient focus: POLYETHYLENE GLYCOLS
SIMVASTATIN drug variants containing POLYETHYLENE GLYCOLS
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | simvastatin | 54868-6066 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POLYETHYLENE GLYCOLS
Excipient focus: POVIDONE
SIMVASTATIN drug variants containing POVIDONE
SIMVASTATIN drug variants not containing POVIDONE
Excipient focus: POVIDONES
SIMVASTATIN drug variants containing POVIDONES
| Company | Ingredient | NDC |
|---|---|---|
| State of Florida DOH Central Pharmacy | simvastatin | 53808-0927 |
| Biocon Limited | simvastatin | 65727-065 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing POVIDONES
Excipient focus: PROPYLENE GLYCOL
SIMVASTATIN drug variants containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing PROPYLENE GLYCOL
Excipient focus: PROPYLPARABEN
SIMVASTATIN drug variants containing PROPYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing PROPYLPARABEN
Excipient focus: SILICON DIOXIDE
SIMVASTATIN drug variants containing SILICON DIOXIDE
SIMVASTATIN drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM LAURYL SULFATE
SIMVASTATIN drug variants containing SODIUM LAURYL SULFATE
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing SODIUM LAURYL SULFATE
Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SIMVASTATIN drug variants containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Excipient focus: STARCH, CORN
SIMVASTATIN drug variants containing STARCH, CORN
SIMVASTATIN drug variants not containing STARCH, CORN
Excipient focus: STARCH, PREGELATINIZED CORN
SIMVASTATIN drug variants containing STARCH, PREGELATINIZED CORN
SIMVASTATIN drug variants not containing STARCH, PREGELATINIZED CORN
Excipient focus: STEARIC ACID
SIMVASTATIN drug variants containing STEARIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | simvastatin and niacin | 54868-5886 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing STEARIC ACID
Excipient focus: TALC
SIMVASTATIN drug variants containing TALC
SIMVASTATIN drug variants not containing TALC
Excipient focus: TITANIUM DIOXIDE
SIMVASTATIN drug variants containing TITANIUM DIOXIDE
SIMVASTATIN drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | simvastatin | 21695-738 |
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| A-S Medication Solutions | simvastatin | 50090-6420 |
| A-S Medication Solutions | simvastatin | 50090-6421 |
| Physicians Total Care Inc | simvastatin | 54868-6066 |
| >Company | >Ingredient | >NDC |
Excipient focus: TRIACETIN
SIMVASTATIN drug variants containing TRIACETIN
SIMVASTATIN drug variants not containing TRIACETIN
Excipient focus: TRIETHYL CITRATE
SIMVASTATIN drug variants containing TRIETHYL CITRATE
SIMVASTATIN drug variants not containing TRIETHYL CITRATE
Excipient focus: WATER
SIMVASTATIN drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Salerno Pharmaceuticals Co | simvastatin | 29273-401 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing WATER
Excipient focus: ZEA MAYS
SIMVASTATIN drug variants containing ZEA MAYS
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | simvastatin | 50090-0999 |
| A-S Medication Solutions | simvastatin | 50090-4801 |
| A-S Medication Solutions | simvastatin | 50090-5019 |
| A-S Medication Solutions | simvastatin | 50090-6420 |
| A-S Medication Solutions | simvastatin | 50090-6421 |
| >Company | >Ingredient | >NDC |
SIMVASTATIN drug variants not containing ZEA MAYS
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LOE / Generic Entry Opportunies 2025 - 2026
NCE-1 Patent Challenge Dates 2025 - 2026
ISSN: 2162-2639
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DrugPatentWatch Alternatives
LOE / Generic Entry Opportunies 2025 - 2026
NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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