DrugPatentWatch Database Preview
KYBELLA Drug Profile
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.
Summary for KYBELLA
| International Patents: | 93 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 9 |
| Patent Applications: | 7,668 |
| 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.
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 | ➤ 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 |
Paragraph IV (Patent) Challenges for KYBELLA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 10 mg/mL (2 mL) | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for KYBELLA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0912493 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 2005112942 | ➤ Try a Free Trial |
| Eurasian Patent Organization | 020806 | ➤ Try a Free Trial |
| South Korea | 20070024527 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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 |
