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KYBELLA Drug Profile
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Which patents cover Kybella, and what generic alternatives are available?
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 one hundred and nineteen patent family members in thirty-four 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.
US ANDA Litigation and Generic Entry Outlook for Kybella
Kybella was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 16, 2028. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for KYBELLA
| International Patents: | 119 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,316 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYBELLA |
| DailyMed Link: | KYBELLA at DailyMed |
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.
Recent Clinical Trials for KYBELLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Juva Skin & Laser Center | Phase 4 |
| University of California, San Diego | Early Phase 1 |
| Zeltiq Aesthetics | Phase 4 |
Recent Litigation for KYBELLA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| KYTHERA BIOPHARMACEUTICALS, INC. v. SLAYBACK PHARMA LLC | 2018-11-09 |
| Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. | 2017-05-31 |
Pharmacology for KYBELLA
| Drug Class | Cytolytic Agent |
| Physiological Effect | Decreased Cell Membrane Integrity |
Synonyms for KYBELLA
| (3ALPHA,5ALPHA,12ALPHA)-3,12-DIHYDROXYCHOLAN-24-OIC ACID |
| (3alpha,5alpha,8alpha,12alpha,14beta,17alpha)-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-((3R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-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-[(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 |
| ATX101 |
| 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 |
| 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, 98.5% |
| 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 |
| Pyrochol |
| s4689 |
| SBB058040 |
| SC-18172 |
| SCHEMBL4300 |
| Septochol |
| SMR000112166 |
| Spectrum5_002007 |
| SR-01000765601 |
| SR-01000765601-2 |
| STK801948 |
| UNII-005990WHZZ |
| UNII-JIY1ILR284 component KXGVEGMKQFWNSR-LLQZFEROSA-N |
| W-3065 |
| Z1945707492 |
| ZINC3914810 |
Paragraph IV (Patent) Challenges for KYBELLA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KYBELLA | SOLUTION;SUBCUTANEOUS | deoxycholic acid | 206333 | 2018-07-13 |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | 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 |
International Patents for KYBELLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200918550 | Start Trial |
| Taiwan | I503396 | Start Trial |
| European Patent Office | 2069383 | Start Trial |
| Hungary | S1700004 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KYBELLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758590 | CA 2017 00067 | Denmark | Start Trial | PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729 |
| 1758590 | 300907 | Netherlands | Start Trial | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT |
| 1758590 | 122018000065 | Germany | Start Trial | PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: IS IS/1/16/071/01 20160729 |
| 1758590 | 2017C/063 | Belgium | Start Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
