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Last Updated: June 17, 2024

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Ascorbic acid - Generic Drug Details


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What are the generic sources for ascorbic acid and what is the scope of freedom to operate?

Ascorbic acid is the generic ingredient in fifteen branded drugs marketed by Mcguff, Sandoz Canada Inc, Hospira, Roche, Abraxis Pharm, Watson Labs, Teligent, Salix Pharms, Novel Labs Inc, and Salix, and is included in fourteen NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for ascorbic acid. One supplier is listed for this compound.

Drug Prices for ascorbic acid

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Drug Sales Revenue Trends for ascorbic acid

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ascorbic acid
Generic Entry Date for ascorbic acid*:
Constraining patent/regulatory exclusivity:
FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ascorbic acid

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Canadian College of Naturopathic MedicinePhase 2
Ottawa Hospital Research InstitiutePhase 2
Centre Hospitalier Intercommunal de Toulon La Seyne sur MerPhase 2

See all ascorbic acid clinical trials

Pharmacology for ascorbic acid
Drug ClassVitamin C
Medical Subject Heading (MeSH) Categories for ascorbic acid

US Patents and Regulatory Information for ascorbic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Hospira M.V.I.-12 ADULT ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e INJECTABLE;INJECTION 008809-004 Aug 8, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz Canada Inc INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265-002 Jan 29, 2004 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mcguff ASCOR ascorbic acid SOLUTION;INTRAVENOUS 209112-001 Oct 2, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novel Labs Inc PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 090145-001 Jan 25, 2012 AA RX No No ⤷  Sign Up ⤷  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

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