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McKesson
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Fish and Richardson
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Generated: December 13, 2018

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KYBELLA Drug Profile

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Which patents cover Kybella, and when can generic versions of Kybella launch?

Kybella is a drug marketed by Kythera Biopharms and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-three patent family members in thirty countries.

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.

Drug patent expirations by year for KYBELLA
Generic Entry Opportunity Date for KYBELLA
Generic Entry Date for KYBELLA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KYBELLA
Medical Subject Heading (MeSH) Categories for KYBELLA
Synonyms for KYBELLA
(3ALPHA,5ALPHA,12ALPHA)-3,12-DIHYDROXYCHOLAN-24-OIC ACID
(3alpha,5beta,12alpha)-3,12-Dihydroxycholan-24-oic acid
(4R)-4-((1S,2S,11S,16S,5R,7R,10R,14R,15R)-5,16-dihydroxy-2,15-dimethyltetracyc lo[8.7.0.0<2,7>.0<11,15>]heptadec-14-yl)pentanoic acid
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic acid
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-DIHYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECAN-14-YL]PENTANOIC ACID
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadecan-14-yl]pentanoic acid
(4R)-4-[(3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
(R)-4-((3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
005990WHZZ
115349-14-9
17-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
17.beta.-(1-Methyl-3-carboxypropyl)-etiocholane-3.alpha.,12.alpha.-diol
1e3v
25793-EP2289879A1
25793-EP2295401A2
25793-EP2315303A1
3-.alpha.,12-.alpha.-Dihydroxycholansaeure
3-alpha,12-alpha-Dihydroxy-5-beta-cholan-24-oic acid
3-alpha,12-alpha-Dihydroxy-5-beta-cholanoic acid
3-alpha,12-alpha-Dihydroxycholansaeure
3-alpha,12-alpha-Dihydroxycholansaeure [German]
3-Hydroxy-polydeoxycholic acid
3,12-Dihydroxycholan-24-oic acid, (3.alpha.,5.beta.,12.alpha.)- #
3,12-Dihydroxycholan-24-oic acid, (3alpha,5beta,12alpha)-
3,12-Dihydroxycholanic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholan-24-oic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholanic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholanoic acid
3.alpha.,12.alpha.-Dihydroxycholanic acid
3|A,12|A-Dihydroxy-5|A-cholanic acid
302-95-4 (mono-hydrochloride salt))
3alpha-Hydroxy-polydeoxycholate
3alpha,12alpha-Dihydroxy-5beta-cholan-24-oic acid
3alpha,12alpha-Dihydroxy-5beta-cholanate
3alpha,12alpha-Dihydroxy-5beta-cholanic acid
4-10-00-01608 (Beilstein Handbook Reference)
5-beta-Cholan-24-oic acid, 3-alpha,12-alpha-dihydroxy-
5-beta-Deoxycholic acid
5.beta.-Cholan-24-oic acid, 3.alpha.,12.alpha.-dihydroxy-
5.beta.-Cholan-24-oic acid,12.alpha.-dihydroxy-
5b-Cholanic acid-3a,12a-diol
5b-Deoxycholate
5b-Deoxycholic acid
5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy-
5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy- (8CI)
7-Deoxycholate
7-Deoxycholic acid
7-Desoxycholic acid
7.alpha.-Deoxycholic acid
71888-65-8 (magnesium (2:1) salt)
728917-93-9
7alpha-Deoxycholic acid
83-44-3
AC1L5BW0
AKOS005622617
AN-774
AS-13233
ATX 101
ATX-101
ATX-101, APIM Therapeutics
ATX101
BB_NC-1415
BBL013877
BDBM50375599
BIDD:PXR0198
bmse000833
BP-13275
BRN 3219882
C04483
CCRIS 1627
CHEBI:28834
CHEMBL406393
Cholan-24-oic acid, 3,12-dihydroxy-, (3-.alpha., 5-.beta.,12-.alpha.)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3-alpha,5-beta,12-alpha)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3-alpha,5-beta,12-alpha)- (9CI)
Cholan-24-oic acid, 3,12-dihydroxy-, (3a,5b,12a)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-, homopolymer
Cholan-24-oic acid,12-dihydroxy-, (3.alpha.,5.beta.,12.alpha.)-
Cholan-24-oic acid,3,12-dihydroxy-, (3a,5b,12a)-
Cholan-24-oic, 3,12-dihydroxy-(3alpha,5beta,12alpha)-
Choleic acid
Cholerebic
Cholic acid, deoxy-
Cholorebic
CS-7613
D02PQB
D10781
DB03619
de-oxycholate
Degalol
Deoxy cholic acid
deoxy-Cholate
deoxy-Cholic acid
Deoxycholatate
deoxycholate
Deoxycholatic acid
DEOXYCHOLIC ACID
Deoxycholic Acid (Desoxycholic Acid), United States Pharmacopeia (USP) Reference Standard
Deoxycholic acid (USAN/INN)
Deoxycholic acid [USAN:INN]
DEOXYCHOLIC ACID FREE ACID
Deoxycholic acid, >=98% (HPLC)
Deoxycholic acid, >=99.0% (T)
Deoxycholic acid, 500 mug/mL in methanol, certified reference material
Deoxycholic acid, 99% 25g
Deoxycholic acid, BioXtra, >=98% (HPLC)
Desoxycholic acid
Desoxycholic acid [NF]
Desoxycholsaeure
Desoxycholsaeure [German]
Desoxycholsaure
Dihydroxycholanoic acid
Droxolan
DTXSID0042662
DXC
EINECS 201-478-5
GTPL610
H681
HMS2270H22
HSDB 293
HY-N0593
KXGVEGMKQFWNSR-LLQZFEROSA-N
Kybella (TN)
l7-.beta.-(1-Methyl-3-carboxypropyl)-etiocholane-3-.alpha.,12-.alpha.-diol
l7-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
LMST04010040
MCULE-2553099876
MFCD00003673
MLS001066423
MLS001306460
MolPort-002-507-414
NCI60_041946
NSC 8797
NSC-8797
NSC8797
PL002011
Proliferating cell nuclear antigen (peptide, cancer), APIM
Pyrochol
s4689
SBB058040
SC-18172
SCHEMBL4300
Septochol
SMR000112166
Sodium deoxycholate
Spectrum5_002007
SR-01000765601
SR-01000765601-2
STK801948
UNII-005990WHZZ
W-3065
Z1945707492
ZINC3914810

US Patents and Regulatory Information for KYBELLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for KYBELLA
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 10 mg/mL (2 mL) ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for KYBELLA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0907 Netherlands ➤ Try a Free Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
2017 00067 Denmark ➤ Try a Free Trial PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
2017006 Lithuania ➤ Try a Free Trial PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cipla
US Army
Boehringer Ingelheim
Teva
Accenture
Covington
Cantor Fitzgerald
Federal Trade Commission

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