FDA Orange Book · active-ingredient family
Semaglutide
Semaglutide: 4 brands, 0 generics; first approved Dec 05, 2017; on patent until Jan 20, 2026.
On patent7 exclusivity periodsHas discontinued products
Generic status & protection
Protected until Jan 20, 2026 (earliest listed patent expiry).
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
4
Generics (ANDA)
0
Listed patents
41
Next patent expiry
Jan 20, 2026
10 mo ago
Brand (NDA) products
Originator applications
- NOVONDA 20963720267 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/1.5ML (1.34MG/ML) SOLUTION SUBCUTANEOUS Discontinued - 4MG/3ML (1.34MG/ML) SOLUTION SUBCUTANEOUS Rx - 8MG/3ML (2.68MG/ML) SOLUTION SUBCUTANEOUS Rx - 2MG/3ML (0.68MG/ML) SOLUTION SUBCUTANEOUS Rx - 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 1MG/0.5ML (1MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - - NOVONDA 21831620254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Rx - 4MG TABLET ORAL Rx - 9MG TABLET ORAL Rx - 25MG TABLET ORAL Rx - - NOVONDA 21305120246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx - 7MG TABLET ORAL Rx - 14MG TABLET ORAL Rx - 1.5MG TABLET ORAL Rx - 4MG TABLET ORAL Rx - 9MG TABLET ORAL Rx - - NOVONDA 215256202112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 1MG/0.5ML (1MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 1.7MG/0.75ML (1.7MG/0.75ML) SOLUTION SUBCUTANEOUS Rx - 2.4MG/0.75ML (2.4MG/0.75ML) SOLUTION SUBCUTANEOUS Rx - 7.2MG/0.75ML (7.2MG/0.75ML) SOLUTION SUBCUTANEOUS Rx - 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 1MG/0.5ML (1MG/0.5ML) SOLUTION SUBCUTANEOUS Rx - 1.7MG/0.75ML (1.7MG/0.75ML) SOLUTION SUBCUTANEOUS Rx - 2.4MG/0.75ML (2.4MG/0.75ML) SOLUTION SUBCUTANEOUS Rx - 9.6MG/3ML (3.2MG/ML) SOLUTION SUBCUTANEOUS Rx -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- D-190New indication / change exclusivity (3 years)
4 mo ago
- I-935New indication exclusivity (3 years)
in 4 mo
- I-961New indication exclusivity (3 years)
in 1 yr 3 mo
- I-973New indication exclusivity (3 years)
in 1 yr 10 mo
- I-976New indication exclusivity (3 years)
in 2 yr
- NPNew product exclusivity (3 years)
in 2 yr 2 mo
- NSNew strength exclusivity (3 years)
in 2 yr 5 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10376652 | 10 mo ago | ProductDelisted | |
| 9861757 | 10 mo ago | ProductDelisted | |
| 9616180 | 10 mo ago | ProductDelisted | |
| 10357616 | 10 mo ago | ProductDelisted | |
| 9108002 | 10 mo ago | ProductDelisted | |
| 8536122 | 8 mo ago | SubstanceProductU-2202 | |
| 8920383 | 4 mo ago | ProductDelisted | |
| 9775953 | 4 mo ago | ProductDelisted | |
| 11097063 | 4 mo ago | ProductDelisted | |
| 10220155 | 4 mo ago | ProductDelisted | |
| RE46363 | 3 mo ago | ProductDelisted | |
| 9687611 | in 4 mo | ProductDelisted | |
| 9457154 | in 11 mo | ProductDelisted | |
| 8129343 | in 5 yr 2 mo | SubstanceProductU-3355 | |
| 11382957 | in 5 yr 2 mo | SubstanceProduct | |
| 9278123 | in 5 yr 2 mo | SubstanceProductU-2628 | |
| 10960052 | in 5 yr 2 mo | Product | |
| 10086047 | in 5 yr 2 mo | Product | |
| 9132239 | in 5 yr 4 mo | ProductDelisted | |
| 11759503 | in 6 yr 5 mo | Product | |
| 10933120 | in 6 yr 5 mo | Product | |
| 11759501 | in 6 yr 5 mo | Product | |
| 11759502 | in 6 yr 5 mo | Product | |
| 12594326 | in 6 yr 5 mo | Product | |
| 11033499 | in 6 yr 9 mo | ProductU-2628 | |
| 10335462 | in 6 yr 9 mo | U-1852 | |
| 9764003 | in 6 yr 9 mo | U-3161 | |
| 12514822 | in 7 yr 7 mo | U-2628 | |
| 12239739 | in 7 yr 7 mo | SubstanceProductU-2628 | |
| 10278923 | in 7 yr 7 mo | SubstanceProductU-2628 | |
| 12569543 | in 10 yr 8 mo | U-4446 | |
| 12214017 | in 12 yr | ProductU-1852 | |
| 11752198 | in 12 yr | ProductU-1852 | |
| 10888605 | in 12 yr | ProductU-1852 | |
| 12295988 | in 12 yr 1 mo | U-1852 | |
| 12551536 | in 12 yr 1 mo | U-4418 | |
| 12029779 | in 12 yr 1 mo | U-3162 | |
| 11833248 | in 12 yr 5 mo | ProductU-2628 | |
| 12396953 | in 12 yr 5 mo | ProductU-2628 | |
| 11478533 | in 13 yr 9 mo | U-3861 | |
| 11318191 | in 14 yr 6 mo | ProductU-1852 |
Approval history
FDA approval span
First approval
9 yr 1 mo ago
Most recent approval
5 mo ago
Approvals span 2017–2026 across 4 FDA applications.
Brand (NDA) 4100%
Generic (ANDA) 00%
Semaglutide: 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.
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