Generic Nascobal Availability
Last updated on Apr 10, 2024.
Nascobal is a brand name of cyanocobalamin, approved by the FDA in the following formulation(s):
NASCOBAL (cyanocobalamin - gel, metered;nasal)
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Manufacturer: PAR PHARM
Approval date: November 5, 1996
Strength(s): 0.5MG/INH (discontinued)
NASCOBAL (cyanocobalamin - spray, metered;nasal)
Has a generic version of Nascobal been approved?
A generic version of Nascobal has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Nascobal and have been approved by the FDA:
cyanocobalamin spray, metered;nasal
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Manufacturer: LUPIN
Approval date: June 30, 2023
Strength(s): 0.5MG/SPRAY [AB] -
Manufacturer: PADAGIS ISRAEL
Approval date: September 9, 2020
Strength(s): 0.5MG/SPRAY [AB]
Note: No generic formulation of the following product is available.
- cyanocobalamin - gel, metered;nasal
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nascobal. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Patent 7,229,636
Patent expiration dates:
- August 1, 2024✓✓
- August 1, 2024
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Patent 7,404,489
Patent expiration dates:
- March 12, 2024✓
- March 12, 2024
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Patent 7,879,349
Patent expiration dates:
- August 1, 2024✓✓
- August 1, 2024
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Patent 8,003,353
Patent expiration dates:
- August 1, 2024✓
- August 1, 2024
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Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent 8,940,714
Issued: January 27, 2015
Inventor(s): Quay Steven C. & Aprile Peter C. & Go Zenaida O. & Sileno Anthony P.
Assignee(s): Par Pharmaceutical, Inc.A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Patent expiration dates:
- February 26, 2024✓
- February 26, 2024
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Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent 9,415,007
Issued: August 16, 2016
Inventor(s): Quay Steven C. & Aprile Peter C. & Go Zenaida O. & Sileno Anthony P.
Assignee(s): PAR PHARMACEUTICAL, INC.A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Patent expiration dates:
- July 28, 2024✓
- July 28, 2024
More about Nascobal (cyanocobalamin)
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- Drug class: vitamins
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.