Deoxycholic acid - Generic Drug Details

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What are the generic drug sources for deoxycholic acid and what is the scope of freedom to operate?

Deoxycholic acid is the generic ingredient in two branded drugs marketed by Wilshire Pharms Inc and Abbvie, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deoxycholic acid has one hundred and forty-one patent family members in thirty-seven countries.

There are thirty-three drug master file entries for deoxycholic acid. One supplier is listed for this compound.

Summary for deoxycholic acid

International Patents:	141
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	20
Patent Applications:	6,163
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deoxycholic acid
What excipients (inactive ingredients) are in deoxycholic acid?	deoxycholic acid excipients list
DailyMed Link:	deoxycholic acid at DailyMed

Recent Clinical Trials for deoxycholic acid

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Phase 1
Massachusetts General Hospital	Phase 1
Juva Skin & Laser Center	Phase 4

See all deoxycholic acid clinical trials

Pharmacology for deoxycholic acid

Drug Class	Cytolytic Agent
Physiological Effect	Decreased Cell Membrane Integrity

Medical Subject Heading (MeSH) Categories for deoxycholic acid

Cholagogues and Choleretics

Anatomical Therapeutic Chemical (ATC) Classes for deoxycholic acid

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for DEOXYCHOLIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYBELLA	Injection	deoxycholic acid	10 mg/mL (2 mL)	206333	1	2018-07-13

US Patents and Regulatory Information for deoxycholic acid

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,101,593	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,242,294	⤷ Subscribe		Y		⤷ Subscribe
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,653,058	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	9,522,155	⤷ Subscribe	Y			⤷ Subscribe
Wilshire Pharms Inc	DEOXYCHOLIC ACID	deoxycholic acid	SOLUTION;SUBCUTANEOUS	212296-001	Apr 2, 2021	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	10,500,214	⤷ Subscribe	Y			⤷ Subscribe
>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 deoxycholic acid

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Country	Patent Number	Title	Estimated Expiration
Japan	5279274		⤷ Subscribe
Japan	2012176966	METHOD AND RELATED COMPOSITION FOR REDUCTION OF FAT	⤷ Subscribe
Taiwan	201534684	Synthetic bile acid composition, method, and preparation	⤷ Subscribe
South Korea	101916024		⤷ Subscribe
Cyprus	1112204		⤷ Subscribe
Israel	207126	תכשירים להפחתה בשומן (Compositions for reduction of fat)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for deoxycholic acid

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758590	CR 2017 00067	Denmark	⤷ Subscribe	PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 (DK) 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
3692995	301229	Netherlands	⤷ Subscribe	PRODUCT NAME: DEOXYCHOLAAT; NATIONAL REGISTRATION NO/DATE: RVG120593 20170804; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576	122020000056	Germany	⤷ Subscribe	PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
1758590	PA2017006	Lithuania	⤷ Subscribe	PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
2380576	SPC/GB20/050	United Kingdom	⤷ Subscribe	PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2380576	20C1048	France	⤷ Subscribe	PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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