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 ZYDUS PHARMS on April 15^th, 2022.

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Summary for NASCOBAL

US Patents:	6
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	108
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NASCOBAL
Drug Sales Revenues:	Drug sales revenues for NASCOBAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASCOBAL
What excipients (inactive ingredients) are in NASCOBAL?	NASCOBAL excipients list
DailyMed Link:	NASCOBAL at DailyMed

Drug patent expirations by year for NASCOBAL

Recent Clinical Trials for NASCOBAL

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

Sponsor	Phase
Swedish Orphan Biovitrum	Phase 1

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Pharmacology for NASCOBAL

Drug Class	Vitamin B12

Anatomical Therapeutic Chemical (ATC) Classes for NASCOBAL

B03BA	Vitamin B12 (cyanocobalamin and analogues)
B03B	VITAMIN B12 AND FOLIC ACID
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

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: SUPPLEMENT FOR VITAMIN B12 DEFICIENCIES

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Glossary

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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		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		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		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		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996	⤷ 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.

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Country	Patent Number	Title	Estimated Expiration
Hungary	196124	PROCESS FOR PRODUCING PHARMACEUTICS COMPRISING B UNDER 12 VITAMIN AND SUITABLE FOR NASAL DOSAGE	⤷ Try a Trial
Germany	3672430		⤷ Try a Trial
Australia	584703		⤷ Try a Trial
Japan	S62500789		⤷ Try a Trial
Spain	553999		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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