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KYBELLA Drug Profile
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Which patents cover Kybella, and what generic alternatives are available?
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.
Summary for KYBELLA
| International Patents: | 93 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 54 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,230 |
| 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
*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
| Drug Class | Cytolytic Agent |
| Physiological Effect | Decreased Cell Membrane Integrity |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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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Non-Orange Book US Patents for KYBELLA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,362,285 | Preparation of bile acids and intermediates thereof | ➤ Sign Up |
| 9,737,549 | Formulations of deoxycholic acid and salts thereof | ➤ Sign Up |
| 8,367,852 | Preparation of bile acids and intermediates thereof | ➤ Sign Up |
| 9,186,364 | Formulations of deoxycholic acid and salts thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for KYBELLA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Costa Rica | 20170070 | ➤ Sign Up |
| European Patent Office | 2069383 | ➤ Sign Up |
| Hong Kong | 1101062 | ➤ Sign Up |
| European Patent Office | 1845938 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for KYBELLA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0907 | Netherlands | ➤ Sign Up | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT |
| 2017 00067 | Denmark | ➤ Sign Up | PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729 |
| 2017006 | Lithuania | ➤ Sign Up | PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
