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KYBELLA Drug Profile
» See Plans and Pricing
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 fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-seven 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
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: | 127 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 80 |
| Clinical Trials: | 11 |
| 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 |
Pharmacology for KYBELLA
| Drug Class | Cytolytic Agent |
| Physiological Effect | Decreased Cell Membrane Integrity |
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 | 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 | |||
| 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 | |||
| Kythera Biopharms | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333-001 | Apr 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
|---|---|---|
| Mexico | 2009013664 | Start Trial |
| Eurasian Patent Organization | 201000032 | Start Trial |
| European Patent Office | 3424508 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006086038 | Start Trial |
| Hong Kong | 1101062 | Start Trial |
| China | 108191940 | 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 | 132017000066197 | Italy | Start Trial | PRODUCT NAME: SALE SODICO DI ACIDO DESOSSICOLICO(BELKYRA); AUTHORISATION NUMBER(S) AND DATE(S): 044896013, 20161219;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 |
| 1758590 | LUC00029 | Luxembourg | Start Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
