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FDA Orange Book · active-ingredient family

Deoxycholic acid

Deoxycholic acid: 1 brand, 1 generic; first approved Apr 29, 2015; generic available.

Generic available
Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Dec 10, 2027
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
14
Next patent expiry
Dec 10, 2027
in 1 yr 5 mo
Originator applications

Brand (NDA) products

KYBELLARLDRS
NDA 2063332015
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/2ML (10MG/ML)SOLUTIONSUBCUTANEOUSRxAP
Abbreviated applications

Generic (ANDA) products (1)

DEOXYCHOLIC ACID
ANDA 2122962021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/2ML (10MG/ML)SOLUTIONSUBCUTANEOUSRxAP
Protection horizon

Patent & exclusivity timeline

20262027202820292030203120322033TodayPatent 7754230 — 2027-12-10Patent 7754230Patent 7622130 — 2027-12-10Patent 7622130Patent 9949986 — 2028-02-21Patent 9949986Patent 9636349 — 2028-02-21Patent 9636349Patent 9522155 — 2028-02-21Patent 9522155Patent 8546367 — 2028-02-21Patent 8546367Patent 8461140 — 2028-02-21Patent 8461140Patent 8883770 — 2028-02-21Patent 8883770Patent 8242294 — 2028-05-16Patent 8242294Patent 8653058 — 2030-03-02Patent 8653058Patent 8367649 — 2030-03-02Patent 8367649Patent 8101593 — 2030-03-02Patent 8101593Patent 10500214 — 2030-03-02Patent 10500214Patent 12161653 — 2032-02-17Patent 12161653
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7754230Dec 10, 2027in 1 yr 5 mo
U-1690
7622130Dec 10, 2027in 1 yr 5 mo
U-1690
9949986Feb 21, 2028in 1 yr 8 mo
U-1940
9636349Feb 21, 2028in 1 yr 8 mo
U-1940
9522155Feb 21, 2028in 1 yr 8 mo
ProductU-1940
8546367Feb 21, 2028in 1 yr 8 mo
ProductU-1690
8461140Feb 21, 2028in 1 yr 8 mo
Product
8883770Feb 21, 2028in 1 yr 8 mo
Product
8242294May 16, 2028in 1 yr 11 mo
Substance
8653058Mar 02, 2030in 3 yr 8 mo
Product
8367649Mar 02, 2030in 3 yr 8 mo
Product
8101593Mar 02, 2030in 3 yr 8 mo
Product
10500214Mar 02, 2030in 3 yr 8 mo
Product
12161653Feb 17, 2032in 5 yr 8 mo
U-1940
FDA approval span

Approval history

First approval
Apr 29, 2015
11 yr 4 mo ago
Most recent approval
Apr 02, 2021
5 yr 4 mo ago

Approvals span 2015–2021 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Deoxycholic acid — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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