Skip to content
Assyro AI
FDA Orange Book · active-ingredient family

Semaglutide

Semaglutide: 4 brands, 0 generics; first approved Dec 05, 2017; on patent until Jan 20, 2026.

On patent30 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
7 mo ago

Brand (NDA) products

Originator applications
  • OZEMPICRLDRS
    NDA 20963720267 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2MG/1.5ML (1.34MG/ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    4MG/3ML (1.34MG/ML)SOLUTIONSUBCUTANEOUSRx—
    8MG/3ML (2.68MG/ML)SOLUTIONSUBCUTANEOUSRx—
    2MG/3ML (0.68MG/ML)SOLUTIONSUBCUTANEOUSRx—
    0.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    0.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    1MG/0.5ML (1MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
  • WEGOVYRLDRS
    NDA 21831620254 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.5MGTABLETORALRx—
    4MGTABLETORALRx—
    9MGTABLETORALRx—
    25MGTABLETORALRx—
  • OZEMPICRLDRS
    NDA 21305120246 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3MGTABLETORALRx—
    7MGTABLETORALRx—
    14MGTABLETORALRx—
    1.5MGTABLETORALRx—
    4MGTABLETORALRx—
    9MGTABLETORALRx—
  • WEGOVYRLDRS
    NDA 215256202112 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    0.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    1MG/0.5ML (1MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    1.7MG/0.75ML (1.7MG/0.75ML)SOLUTIONSUBCUTANEOUSRx—
    2.4MG/0.75ML (2.4MG/0.75ML)SOLUTIONSUBCUTANEOUSRx—
    7.2MG/0.75ML (7.2MG/0.75ML)SOLUTIONSUBCUTANEOUSRx—
    0.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    0.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    1MG/0.5ML (1MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    1.7MG/0.75ML (1.7MG/0.75ML)SOLUTIONSUBCUTANEOUSRx—
    2.4MG/0.75ML (2.4MG/0.75ML)SOLUTIONSUBCUTANEOUSRx—
    9.6MG/3ML (3.2MG/ML)SOLUTIONSUBCUTANEOUSRx—

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 10376652: 2026-01-20Patent 10376652Patent 9861757: 2026-01-20Patent 9861757Patent 9616180: 2026-01-20Patent 9616180Patent 10357616: 2026-01-20Patent 10357616Patent 9108002: 2026-01-20Patent 9108002Patent 8536122: 2026-03-20Patent 8536122Patent 8920383: 2026-07-17Patent 8920383Patent 9775953: 2026-07-17Patent 9775953Patent 11097063: 2026-07-17Patent 11097063Patent 10220155: 2026-07-17Patent 10220155Exclusivity D-190: 2026-07-21Exclusivity D-190Patent RE46363: 2026-08-03Patent RE46363Patent 9687611: 2027-02-27Patent 9687611Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-935: 2027-03-08Exclusivity I-935Patent 9457154: 2027-09-29Patent 9457154Exclusivity I-961: 2028-01-28Exclusivity I-961Exclusivity I-961: 2028-01-28Exclusivity I-961Exclusivity I-961: 2028-01-28Exclusivity I-961Exclusivity I-961: 2028-01-28Exclusivity I-961Exclusivity I-973: 2028-08-15Exclusivity I-973Exclusivity I-973: 2028-08-15Exclusivity I-973Exclusivity I-973: 2028-08-15Exclusivity I-973Exclusivity I-973: 2028-08-15Exclusivity I-973Exclusivity I-973: 2028-08-15Exclusivity I-973Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity I-976: 2028-10-17Exclusivity I-976Exclusivity NP: 2028-12-22Exclusivity NPExclusivity NP: 2028-12-22Exclusivity NPExclusivity NP: 2028-12-22Exclusivity NPExclusivity NP: 2028-12-22Exclusivity NPExclusivity NS: 2029-03-19Exclusivity NSPatent 8129343: 2031-12-05Patent 8129343Patent 11382957: 2031-12-16Patent 11382957Patent 9278123: 2031-12-16Patent 9278123Patent 10960052: 2031-12-16Patent 10960052Patent 10086047: 2031-12-16Patent 10086047Patent 9132239: 2032-02-01Patent 9132239Patent 11759503: 2033-03-15Patent 11759503Patent 10933120: 2033-03-15Patent 10933120Patent 11759501: 2033-03-15Patent 11759501Patent 11759502: 2033-03-15Patent 11759502Patent 12594326: 2033-03-15Patent 12594326Patent 11033499: 2033-06-19Patent 11033499Patent 10335462: 2033-06-21Patent 10335462Patent 9764003: 2033-06-21Patent 9764003Patent 12514822: 2034-05-02Patent 12514822Patent 12239739: 2034-05-02Patent 12239739Patent 10278923: 2034-05-02Patent 10278923Patent 12569543: 2037-04-28Patent 12569543Patent 12214017: 2038-08-24Patent 12214017Patent 11752198: 2038-08-24Patent 11752198Patent 10888605: 2038-08-24Patent 10888605Patent 12295988: 2038-10-10Patent 12295988Patent 12551536: 2038-10-10Patent 12551536Patent 12029779: 2038-10-10Patent 12029779Patent 11833248: 2039-02-01Patent 11833248Patent 12396953: 2039-02-01Patent 12396953Patent 11478533: 2040-05-13Patent 11478533Patent 11318191: 2041-02-17Patent 11318191
Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman
  • I-961New indication exclusivity (3 years)

    in 1 yr 6 mo

  • I-961New indication exclusivity (3 years)

    in 1 yr 6 mo

  • I-961New indication exclusivity (3 years)

    in 1 yr 6 mo

  • I-961New indication exclusivity (3 years)

    in 1 yr 6 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

  • D-190New indication / change exclusivity (3 years)

    14 d ago

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

  • NSNew strength exclusivity (3 years)

    in 2 yr 8 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-976New indication exclusivity (3 years)

    in 2 yr 3 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • NPNew product exclusivity (3 years)

    in 2 yr 5 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • NPNew product exclusivity (3 years)

    in 2 yr 5 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • NPNew product exclusivity (3 years)

    in 2 yr 5 mo

  • I-935New indication exclusivity (3 years)

    in 7 mo

  • NPNew product exclusivity (3 years)

    in 2 yr 5 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
103766527 mo ago
ProductDelisted
98617577 mo ago
ProductDelisted
96161807 mo ago
ProductDelisted
103576167 mo ago
ProductDelisted
91080027 mo ago
ProductDelisted
85361225 mo ago
SubstanceProductU-2202
892038318 d ago
ProductDelisted
977595318 d ago
ProductDelisted
1109706318 d ago
ProductDelisted
1022015518 d ago
ProductDelisted
RE463631 d ago
ProductDelisted
9687611in 7 mo
ProductDelisted
9457154in 1 yr 2 mo
ProductDelisted
8129343in 5 yr 5 mo
SubstanceProductU-3355
11382957in 5 yr 5 mo
SubstanceProduct
9278123in 5 yr 5 mo
SubstanceProductU-2628
10960052in 5 yr 5 mo
Product
10086047in 5 yr 5 mo
Product
9132239in 5 yr 7 mo
ProductDelisted
11759503in 6 yr 9 mo
Product
10933120in 6 yr 9 mo
Product
11759501in 6 yr 9 mo
Product
11759502in 6 yr 9 mo
Product
12594326in 6 yr 9 mo
Product
11033499in 7 yr
ProductU-2628
10335462in 7 yr
U-1852
9764003in 7 yr
U-3161
12514822in 7 yr 10 mo
U-2628
12239739in 7 yr 10 mo
SubstanceProductU-2628
10278923in 7 yr 10 mo
SubstanceProductU-2628
12569543in 10 yr 11 mo
U-4446
12214017in 12 yr 3 mo
ProductU-1852
11752198in 12 yr 3 mo
ProductU-1852
10888605in 12 yr 3 mo
ProductU-1852
12295988in 12 yr 4 mo
U-1852
12551536in 12 yr 4 mo
U-4418
12029779in 12 yr 4 mo
U-3162
11833248in 12 yr 8 mo
ProductU-2628
12396953in 12 yr 8 mo
ProductU-2628
11478533in 14 yr
U-3861
11318191in 14 yr 9 mo
ProductU-1852

Approval history

FDA approval span
First approval
8 yr 9 mo ago
Most recent approval
2 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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo