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.
Summary for NASCOBAL
| US Patents: | 6 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 1 |
| Patent Applications: | 57 |
| 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 |
Recent Clinical Trials for NASCOBAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Swedish Orphan Biovitrum | Phase 1 |
Pharmacology for NASCOBAL
| Drug Class | Vitamin B12 |
Anatomical Therapeutic Chemical (ATC) Classes for NASCOBAL
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 |
|---|---|---|---|
| African Intellectual Property Organization (OAPI) | 8486 | ⤷ Try a Trial | |
| Japan | S62500789 | ⤷ Try a Trial | |
| Hungary | 196124 | PROCESS FOR PRODUCING PHARMACEUTICS COMPRISING B UNDER 12 VITAMIN AND SUITABLE FOR NASAL DOSAGE | ⤷ Try a Trial |
| Germany | 3672430 | ⤷ Try a Trial | |
| Canada | 1300014 | COMPOSITIONS NASAUX CONTENANT LA VITAMINE B (NASAL COMPOSITIONS CONTAINING VITAMIN B) | ⤷ Try a Trial |
| Denmark | 603886 | ⤷ Try a Trial | |
| Hungary | T43493 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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