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Generated: September 22, 2018

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BYSTOLIC Drug Profile

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When do Bystolic patents expire, and when can generic versions of Bystolic launch?

Bystolic is a drug marketed by Allergan Sales Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

Drug patent expirations by year for BYSTOLIC
Pharmacology for BYSTOLIC
Medical Subject Heading (MeSH) Categories for BYSTOLIC
Synonyms for BYSTOLIC
(+/-)-[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 (HCl)
(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
213132-06-0
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
920275-27-0
920299-33-8
A809319
AB0005261
AB2000144
ABP000746
AC-4233
AC-5636
AK-60812
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
Bio-0068
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
HE068690
HE172678
HY-B0203A
J-010524
JWEXHQAEWHKGCW-BIISKSHESA-N
JWEXHQAEWHKGCW-UHFFFAOYSA-N
KS-00000ZDS
KS-1455
Lobivon
MFCD09841077
MolPort-015-163-751
MolPort-019-992-297
MolPort-023-276-830
N0954
Narbivolol
NCGC00183875-01
NCGC00263579-01
Nebilet
Nebilox
Nebivolol (hydrochloride)
Nebivolol HCl
Nebivolol hydrochloride
Nebivolol hydrochloride (USAN)
Nebivolol Hydrochloride [USAN]
Nebivolol hydrochloride, >=98% (HPLC)
Nebivolol hydrochloride/
Nebivolol Impurity 13 (SS,SS)
Nebivolol Impurity 14
NEBIVOLOLHYDROCHLORIDE
PubChem18274
Q-201456
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
TC-157581
Tox21_113618
Tox21_113618_1
UNII-JGS34J7L9I component JWEXHQAEWHKGCW-BIISKSHESA-N
UNII-JGS34J7L9I component JWEXHQAEWHKGCW-VCVZPGOSSA-N
W-60374

US Patents and Regulatory Information for BYSTOLIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Expired US Patents for BYSTOLIC

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

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Paragraph IV (Patent) Challenges for BYSTOLIC
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 2.5 mg, 5 mg, 10 mg, and 20 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for BYSTOLIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/048 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
C0002 Belgium ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
50031 Netherlands ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Baxter
Fuji
Merck
Chinese Patent Office
Queensland Health
Cipla
Harvard Business School
Express Scripts

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.