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Last Updated: August 4, 2020

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NASCOBAL Drug 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. Twelve suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

US ANDA Litigation and Generic Entry Outlook for Nascobal

A generic version of NASCOBAL was approved as cyanocobalamin by WEST-WARD PHARMS INT on December 31st, 1969.

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Paragraph IV (Patent) Challenges for NASCOBAL
Tradename Dosage Ingredient NDA Submissiondate
NASCOBAL SPRAY, METERED;NASAL cyanocobalamin 021642 2017-04-28

US Patents and Regulatory Information for NASCOBAL

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   Start Trial   Start Trial   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Endo Pharms Inc NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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