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Last Updated: May 19, 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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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: NASAL ADMINISTRATION OF CYANOCOBALAMIN

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: NASAL ADMINISTRATION OF CYANOCOBALAMIN

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

Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Try a Trial ⤷  Try a Trial
Par Pharm NASCOBAL cyanocobalamin GEL, METERED;NASAL 019722-001 Nov 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 ⤷  Try a Trial ⤷  Try a Trial
>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
Hungary T43493 ⤷  Try a Trial
Norway 865010 ⤷  Try a Trial
Denmark 603886 ⤷  Try a Trial
Norway 174182 ⤷  Try a Trial
African Intellectual Property Organization (OAPI) 8486 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 8605988 ⤷  Try a Trial
Ireland 58533 Nasal compositions containing vitamin B ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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