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Nebivolol hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for nebivolol hydrochloride?

Nebivolol hydrochloride is the generic ingredient in three branded drugs marketed by Indchemie Health, Alkem Labs Ltd, Forest Labs, Amerigen Pharms Ltd, Watson Labs Inc, and Forest Labs Llc, and is included in six NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-seven patent family members in twenty-two countries.

There are fourteen drug master file entries for nebivolol hydrochloride. Seven suppliers are listed for this compound.

Summary for Generic Name: nebivolol hydrochloride

Tradenames:3
Patents:4
Applicants:6
NDAs:6
Drug Master File Entries: see list14
Suppliers / Packagers: see list7
Bulk Api Vendors: see list83
Clinical Trials: see list1,024
Patent Applications: see list1,419
Drug Prices:see low prices
DailyMed Link:nebivolol hydrochloride at DailyMed

Pharmacology for Ingredient: nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL203741-003Jun 24, 2015DISCNNoNo► Subscribe► Subscribe
Watson Labs Inc
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL203683-002Nov 27, 2015DISCNNoNo► Subscribe► Subscribe
Amerigen Pharms Ltd
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL203659-003Apr 16, 2015DISCNNoNo► Subscribe► Subscribe
Watson Labs Inc
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL203683-003Nov 27, 2015DISCNNoNo► Subscribe► Subscribe
Amerigen Pharms Ltd
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL203659-001Apr 16, 2015DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-002Dec 17, 20075,759,580► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-003Dec 17, 20075,759,580► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-005Oct 8, 20085,759,580► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-004Dec 17, 20075,759,580► Subscribe
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International Patent Family for Ingredient: nebivolol hydrochloride

Country Document Number Estimated Expiration
South Korea970011287► Subscribe
Luxembourg88842► Subscribe
Cyprus1802► Subscribe
Netherlands950031► Subscribe
Germany68903516► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NEBIVOLOL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/GB96/048United Kingdom► SubscribePRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
50031Netherlands► SubscribePRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
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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 verifification 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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