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Last Updated: July 20, 2024

NASCOBAL Drug Patent Profile


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When do Nascobal patents expire, and what generic alternatives are available?

Nascobal is a drug marketed by Par Pharm and Endo Pharms Inc and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NASCOBAL is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nascobal

A generic version of NASCOBAL was approved as cyanocobalamin by PADAGIS ISRAEL on September 9th, 2020.

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Drug patent expirations by year for NASCOBAL
Drug Prices for NASCOBAL

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Drug Sales Revenue Trends for NASCOBAL

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Recent Clinical Trials for NASCOBAL

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SponsorPhase
Swedish Orphan BiovitrumPhase 1

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Pharmacology for NASCOBAL
Drug ClassVitamin B12
Paragraph IV (Patent) Challenges for NASCOBAL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NASCOBAL Nasal Spray cyanocobalamin 500 mcg/spray 021642 1 2017-04-28

US Patents and Regulatory Information for NASCOBAL

NASCOBAL is protected by six US patents.

Patents protecting NASCOBAL

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: NASAL ADMINISTRATION OF CYANOCOBALAMIN

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: NASAL ADMINISTRATION OF CYANOCOBALAMIN

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: SUPPLEMENT FOR VITAMIN B12 DEFICIENCIES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm NASCOBAL cyanocobalamin GEL, METERED;NASAL 019722-001 Nov 5, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NASCOBAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Pharm NASCOBAL cyanocobalamin GEL, METERED;NASAL 019722-001 Nov 5, 1996 ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Sign Up ⤷  Sign Up
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NASCOBAL

See the table below for patents covering NASCOBAL around the world.

Country Patent Number Title Estimated Expiration
Australia 5775786 ⤷  Sign Up
Japan S62500789 ⤷  Sign Up
Spain 8800047 ⤷  Sign Up
European Patent Office 0216917 NASAL COMPOSITIONS CONTAINING VITAMIN B 12 ⤷  Sign Up
Hungary 196124 PROCESS FOR PRODUCING PHARMACEUTICS COMPRISING B UNDER 12 VITAMIN AND SUITABLE FOR NASAL DOSAGE ⤷  Sign Up
Japan H0669952 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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