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Orange Book drug · Brand (NDA)

Ozempic

Semaglutide

RLDNDA 209637 7 strengths Novo
Approved
Dec 05, 2017
Strengths
7
Listed patents
18
Applications
2

What does the FDA Orange Book show for Ozempic?

Ozempic contains Semaglutide and appears in 2 FDA Orange Book applications. NDA 209637 is the lead filing, with 7 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 209637

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
7

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

Marketing categories
Discontinued and 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
18

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

Exclusivity records
1

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
0012MG/1.5ML (1.34MG/ML)SOLUTIONSUBCUTANEOUSDiscontinuedNone posted
RLD
0024MG/3ML (1.34MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0038MG/3ML (2.68MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0042MG/3ML (0.68MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0050.25MG/0.5ML (0.25MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0060.5MG/0.5ML (0.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0071MG/0.5ML (1MG/0.5ML)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 209637.

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

Status varies by presentation: 1 on the Discontinued Drug Product List and 6 prescription

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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

8 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 10, 2038. 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 209637 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
Wegovy · NDA 215256

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-209637

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

7 approved presentations · NDA 209637
RLDDiscontinued
Strength
2MG/1.5ML (1.34MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 9 mo ago

  2. Patent 10357616 expires

    Listed drug product patent expiration.

    6 mo ago

  3. Patent 10376652 expires

    Listed drug product patent expiration.

    6 mo ago

  4. Patent 9108002 expires

    Listed drug product patent expiration.

    6 mo ago

  5. Patent 9616180 expires

    Listed drug product patent expiration.

    6 mo ago

  6. Patent 9861757 expires

    Listed drug product patent expiration.

    6 mo ago

  7. Patent 8536122 expires

    Listed drug substance patent expiration.

    4 mo ago

  8. Patent 10220155 expires

    Listed drug product patent expiration.

    9 d ago

  9. Patent 11097063 expires

    Listed drug product patent expiration.

    9 d ago

  10. Patent 8920383 expires

    Listed drug product patent expiration.

    9 d ago

  11. Patent 9775953 expires

    Listed drug product patent expiration.

    9 d ago

  12. Today

  13. Patent RE46363 expires

    Listed drug product patent expiration.

    in 8 d

  14. Patent 9687611 expires

    Listed drug product patent expiration.

    in 7 mo

  15. Patent 9457154 expires

    Listed drug product patent expiration.

    in 1 yr 2 mo

  16. Exclusivity ends · I-961

    New indication exclusivity (3 years)

    in 1 yr 6 mo

  17. Patent 8129343 expires

    Listed drug substance patent expiration.

    in 5 yr 5 mo

  18. Patent 9132239 expires

    Listed drug product patent expiration.

    in 5 yr 7 mo

  19. Patent 10335462 expires

    Listed method-of-use patent (U-2580) expiration.

    in 7 yr

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 10357616: 2026-01-20Patent 10357616Patent 10376652: 2026-01-20Patent 10376652Patent 9108002: 2026-01-20Patent 9108002Patent 9616180: 2026-01-20Patent 9616180Patent 9861757: 2026-01-20Patent 9861757Patent 8536122: 2026-03-20Patent 8536122Patent 10220155: 2026-07-17Patent 10220155Patent 11097063: 2026-07-17Patent 11097063Patent 8920383: 2026-07-17Patent 8920383Patent 9775953: 2026-07-17Patent 9775953Patent RE46363: 2026-08-03Patent RE46363Patent 9687611: 2027-02-27Patent 9687611Patent 9457154: 2027-09-29Patent 9457154Exclusivity I-961: 2028-01-28Exclusivity I-961Patent 8129343: 2031-12-05Patent 8129343Patent 9132239: 2032-02-01Patent 9132239Patent 10335462: 2033-06-21Patent 10335462
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SEMAGLUTIDE

Strength

2MG/1.5ML (1.34MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 209637

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

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

    in 1 yr 6 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
103576166 mo ago
ProductDelisted
103766526 mo ago
ProductDelisted
91080026 mo ago
ProductDelisted
96161806 mo ago
ProductDelisted
98617576 mo ago
ProductDelisted
85361224 mo ago
SubstanceProductU-2202
102201559 d ago
ProductDelisted
110970639 d ago
ProductDelisted
89203839 d ago
ProductDelisted
97759539 d ago
ProductDelisted
RE46363in 8 d
ProductDelisted
9687611in 7 mo
ProductDelisted
9457154in 1 yr 2 mo
ProductDelisted
8129343in 5 yr 5 mo
SubstanceProductU-2202
9132239in 5 yr 7 mo
ProductDelisted
10335462in 7 yr
U-2580

Other FDA applications for Ozempic

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 Ozempic, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 213051NovoDec 09, 20243—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.

Ozempic: 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 209637 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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