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Orange Book drug · Brand (NDA)

Wegovy

Semaglutide

RLDNDA 215256 10 strengths Novo
Approved
Jun 04, 2021
Strengths
10
Listed patents
10
Applications
2

What does the FDA Orange Book show for Wegovy?

Wegovy contains Semaglutide and appears in 2 FDA Orange Book applications. NDA 215256 is the lead filing, with 10 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 215256

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Novo Nordisk Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
10

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
10

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
3

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0010.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0020.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0031MG/0.5ML (1MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0041.7MG/0.75ML (1.7MG/0.75ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0052.4MG/0.75ML (2.4MG/0.75ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0070.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0080.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0091MG/0.5ML (1MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0101.7MG/0.75ML (1.7MG/0.75ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0112.4MG/0.75ML (2.4MG/0.75ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Novo Nordisk Inc

The Orange Book identifies this organization as the applicant responsible for NDA 215256.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

10 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

9 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 17, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 2 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215256 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Subcutaneous

Semaglutide

2 applications
Product rows
18
Active applications
2
Active with AB row
0
Ozempic · NDA 209637

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-215256

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

10 approved presentations · NDA 215256
RLDRS
Strength
0.25MG/0.5ML (0.25MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr 3 mo ago

  2. Patent 8536122 expires

    Listed drug substance patent expiration.

    4 mo ago

  3. Today

  4. Exclusivity ends · I-935

    New indication exclusivity (3 years)

    in 8 mo

  5. Exclusivity ends · I-973

    New indication exclusivity (3 years)

    in 2 yr 1 mo

  6. Patent 8129343 expires

    Listed drug substance patent expiration.

    in 5 yr 5 mo

  7. Patent 9764003 expires

    Listed method-of-use patent (U-3161) expiration.

    in 7 yr

  8. Patent 10888605 expires

    Listed drug product patent expiration.

    in 12 yr 3 mo

  9. Patent 11752198 expires

    Listed drug product patent expiration.

    in 12 yr 3 mo

  10. Patent 12214017 expires

    Listed drug product patent expiration.

    in 12 yr 3 mo

  11. Patent 11478533 expires

    Listed method-of-use patent (U-3861) expiration.

    in 14 yr

  12. Patent 11318191 expires

    Listed drug product patent expiration.

    in 14 yr 9 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 8536122: 2026-03-20Patent 8536122Exclusivity I-935: 2027-03-08Exclusivity I-935Exclusivity I-973: 2028-08-15Exclusivity I-973Patent 8129343: 2031-12-05Patent 8129343Patent 9764003: 2033-06-21Patent 9764003Patent 10888605: 2038-08-24Patent 10888605Patent 11752198: 2038-08-24Patent 11752198Patent 12214017: 2038-08-24Patent 12214017Patent 11478533: 2040-05-13Patent 11478533Patent 11318191: 2041-02-17Patent 11318191
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SEMAGLUTIDE

Strength

0.25MG/0.5ML (0.25MG/0.5ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 215256

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • I-935New indication exclusivity (3 years)

    in 8 mo

  • I-973New indication exclusivity (3 years)

    in 2 yr 1 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
85361224 mo ago
SubstanceProduct
8129343in 5 yr 5 mo
SubstanceProduct
9764003in 7 yr
U-3161
10888605in 12 yr 3 mo
ProductU-3162
11752198in 12 yr 3 mo
ProductU-3162
12214017in 12 yr 3 mo
ProductU-3162
11478533in 14 yr
U-3861
11318191in 14 yr 9 mo
ProductU-3162

Other FDA applications for Wegovy

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Wegovy, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 218316NovoDec 22, 20254—Prescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Semaglutide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Wegovy: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 215256 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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