FDA Orange Book · active-ingredient family
Liraglutide
Liraglutide: 2 brands, 11 generics; first approved Jan 25, 2010; generic available.
Generic available1 exclusivity period
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
4
Next patent expiry
Aug 13, 2025
1 yr ago
Brand (NDA) products
Originator applications
- NOVONDA 2063212014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP2 - NOVO NORDISK INCNDA 0223412010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1
Generic (ANDA) products (11)
Abbreviated applications
- LIRAGLUTIDESANDOZANDA 2129722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDEMYLAN INSTITUTIONALANDA 2131552026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDEFRESENIUS KABI USAANDA 2125522026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDEBIOCON PHARMAANDA 2152452026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDEBIOCON PHARMAANDA 2170632026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP2 - LIRAGLUTIDEORBICULARANDA 2172342026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP2 - LIRAGLUTIDEORBICULARANDA 2175902026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDETEVA PHARMSANDA 2145682025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP2 - LIRAGLUTIDELUPINANDA 2154212025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDENANJING KING FRIENDANDA 2181152025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1 - LIRAGLUTIDEHIKMAANDA 2155032024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18MG/3ML (6MG/ML) SOLUTION SUBCUTANEOUS Rx AP1
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- PCPatent-challenge (180-day generic) exclusivity
5 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8114833 | 1 yr ago | Product | |
| 8114833*PED | 6 mo ago | ||
| 9968659 | in 10 yr 7 mo | U-2438 | |
| 9968659*PED | in 11 yr 1 mo |
Approval history
FDA approval span
First approval
16 yr 9 mo ago
Most recent approval
1 mo ago
Approvals span 2010–2026 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Liraglutide: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
