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Last Updated: December 13, 2019

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Nebivolol hydrochloride - Generic Drug Details

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What are the generic sources for nebivolol hydrochloride and what is the scope of freedom to operate?

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

Nebivolol hydrochloride has twenty-seven patent family members in twenty-two countries.

There are fourteen drug master file entries for nebivolol hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for nebivolol hydrochloride

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

SponsorPhase
Stanford UniversityPhase 2
The Novo Nordisk FoundationPhase 4
Danish Heart FoundationPhase 4

See all nebivolol hydrochloride clinical trials

Recent Litigation for nebivolol hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan Sales, LLC v. Ajanta Pharma Ltd.2019-07-02
Allergan Sales LLC v. Aurobindo Pharma USA Inc.2018-01-19
IN RE: Nebivolol ('040) Patent Litigation2012-03-29

See all nebivolol hydrochloride litigation

PTAB Litigation
PetitionerDate
Lower Drug Prices For Consumers, LLC2015-12-22

See all nebivolol hydrochloride litigation

Generic filers with tentative approvals for NEBIVOLOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nebivolol hydrochloride
Medical Subject Heading (MeSH) Categories for nebivolol hydrochloride
Synonyms for nebivolol hydrochloride
(+/-)-[2R*(1S*5S*(S*))]-?,?'-[Iminobis(methylene)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol)
(+/-)[R*,S*,S*,S*]-alpha,alpha'-[imino-bis (methylene)] bis [6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride
(1R)-1-[(2R)-6-fluoro-3,4-dihydro-2H-chromen-2-yl]-2-[[(2R)-2-[(2S)-6-fluoro-3,4-dihydro-2H-chromen-2-yl]-2-hydroxyethyl]amino]ethanol;hydrochloride
(1R)-1-[(2S)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-({(2R)-2-[(2R)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-hydroxyethyl}amino)ethan-1-ol hydrochloride
(1RS,1'RS)-1,1'-((2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl))-2,2'-iminodiethanol hydrochloride
(1S)-1-[(2R)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-({(2S)-2-[(2S)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-hydroxyethyl}amino)ethan-1-ol hydrochloride
(1S)-1-[(2S)-6-fluoranyl-3,4-dihydro-2H-chromen-2-yl]-2-[[(2S)-2-[(2R)-6-fluoranyl-3,4-dihydro-2H-chromen-2-yl]-2-oxidanyl-ethyl]amino]ethanol hydrochloride
(1S)-1-[(2S)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-[[(2S)-2-[(2R)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-hydroxyethyl]amino]ethanol hydrochloride
(2R)-2-[(2S)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-N-{(2R)-2-[(2R)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-hydroxyethyl}-2-hydroxyethan-1-aminium chloride
(2S)-2-[(2R)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-N-{(2S)-2-[(2S)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]-2-hydroxyethyl}-2-hydroxyethan-1-aminium chloride
(R,S,S,S)-nebivolol hydrochloride
(R,S,S,S)-nebivolol monohydrochloride
(S,R,R,R)-nebivolol hydrochloride
(S,R,R,R)-nebivolol monohydrochloride
1-(6-fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-ethyl]amino]ethanol hydrochloride
118457-15-1
152520-56-4
169293-50-9
2,2'-Azanediylbis(1-(6-fluorochroman-2-yl)ethanol) hydrochloride
2H-1-benzopyran-2-methanol, alpha,alpha'-(iminobis(methylene))bis(6-fluoro-3,4-dihydro-, hydrochloride, (alphaR,alpha'R,2R,2'S)-rel-
3921AH
520N564
8665AA
920299-33-8
A809319
AB0005261
AB2000144
ABP000746
AC-4233
AC-5636
AKOS016006035
AKOS024457656
AKOS030228370
alpha,alpha'[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol]hydrochloride
AN-10766
AN-12152
ANW-68836
API0008844
AS-12100
AX8144075
B1341
Bystolic
Bystolic (TN)
C22H25F2NO4.ClH
C22H26ClF2NO4
CAS-169293-50-9
CCG-214847
CHEBI:132913
CHEBI:132914
CHEMBL1201731
CHEMBL2358570
CS-2142
CTK8C2685
CTK8E9715
D06622
dexnebivolol hydrochloride
DSSTox_CID_28991
DSSTox_GSID_49065
DSSTox_RID_83256
DTXSID1049065
FT-0652243
FT-0655833
HY-B0203A
J-010524
JWEXHQAEWHKGCW-BIISKSHESA-N
JWEXHQAEWHKGCW-UHFFFAOYSA-N
KS-00000ZDS
KS-1455
MolPort-015-163-751
MolPort-019-992-297
MolPort-023-276-830
N0954
Narbivolol
NCGC00183875-01
NCGC00263579-01
Nebilox
Nebivolol (Bystolic)
Nebivolol (hydrochloride)
Nebivolol HCl
Nebivolol hydrochloride (USAN)
Nebivolol Hydrochloride [USAN]
Nebivolol hydrochloride, >=98% (HPLC)
Nebivolol hydrochloride/
PubChem18274
Q-201456
R 67555
R-67145
R-67145;Bystolic
R-67555
R067555
rac Nebivolol hydrochloride
rel-(aR,a inverted exclamation markaR,2R,2 inverted exclamation markaS)-a,a inverted exclamation marka-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride
RL01951
Ro-67555
RT-014679
s1549
SCHEMBL2284755
SCHEMBL514784
SCHEMBL514785
Silostar
SW219269-1
TC-157581
Tox21_113618
Tox21_113618_1
UNII-JGS34J7L9I component JWEXHQAEWHKGCW-BIISKSHESA-N
UNII-JGS34J7L9I component JWEXHQAEWHKGCW-VCVZPGOSSA-N
W-60374
Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BYSTOLIC TABLET;ORAL nebivolol hydrochloride 021742 2011-12-19

US Patents and Regulatory Information for nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-003 Jul 29, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203683-004 Nov 27, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203741-003 Jun 24, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start 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 nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007   Start Trial   Start Trial
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008   Start Trial   Start Trial
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007   Start Trial   Start Trial
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for nebivolol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 C950031 Netherlands   Start Trial PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0334429 SPC/GB96/048 United Kingdom   Start Trial PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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