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Orange Book drug · Brand (NDA)

Bydureon

Exenatide Synthetic

DiscontinuedRLDNDA 022200 Astrazeneca Ab
Approved
Jan 27, 2012
Strengths
1
Listed patents
12

What does the FDA Orange Book show for Bydureon?

Bydureon contains Exenatide Synthetic and is the new drug FDA Orange Book record for NDA 022200. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 022200

New drug application identity from the Orange Book snapshot.

Application holder
Astrazeneca Ab

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

Product presentations
1

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

Marketing categories
Discontinued

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

Reference roles
RLD

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
12

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

Exclusivity records
0

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/VIALFOR SUSPENSION, EXTENDED RELEASESUBCUTANEOUSDiscontinuedNone posted
RLD

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

Astrazeneca Ab

The Orange Book identifies this organization as the applicant responsible for NDA 022200.

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

1 presentation listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

10 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Sep 21, 2028. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 2 other NDAs found

1 of the related ANDA application is 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 022200 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

For Suspension, Extended Release · Subcutaneous

Exenatide Synthetic

1 application
Product rows
2
Active applications
0
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-022200

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.

Product detail

NDA 022200
RLDDiscontinued
Strength
2MG/VIAL
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    14 yr 8 mo ago

  2. Patent 6515117 expires

    Listed drug substance patent expiration.

    10 mo ago

  3. Patent 6515117*PED expires

    Listed listed patent expiration.

    4 mo ago

  4. Today

  5. Patent 8329648 expires

    Listed method-of-use patent (U-2590) expiration.

    in 23 d

  6. Patent 8329648 expires

    Listed method-of-use patent (U-2589) expiration.

    in 23 d

  7. Patent 8329648 expires

    Listed method-of-use patent (U-2595) expiration.

    in 23 d

  8. Patent 8329648 expires

    Listed method-of-use patent (U-2593) expiration.

    in 23 d

  9. Patent 8329648 expires

    Listed method-of-use patent (U-2596) expiration.

    in 23 d

  10. Patent 8329648 expires

    Listed method-of-use patent (U-2588) expiration.

    in 23 d

  11. Patent 8329648 expires

    Listed method-of-use patent (U-2594) expiration.

    in 23 d

  12. Patent 8329648 expires

    Listed method-of-use patent (U-3188) expiration.

    in 23 d

  13. Patent 8329648 expires

    Listed method-of-use patent (U-3189) expiration.

    in 23 d

  14. Patent 8329648 expires

    Listed method-of-use patent (U-3190) expiration.

    in 23 d

  15. Patent 8906851 expires

    Listed method-of-use patent (U-2593) expiration.

    in 23 d

  16. Patent 8906851 expires

    Listed method-of-use patent (U-2589) expiration.

    in 23 d

  17. Patent 8906851 expires

    Listed method-of-use patent (U-2588) expiration.

    in 23 d

  18. Patent 8906851 expires

    Listed method-of-use patent (U-2590) expiration.

    in 23 d

  19. Patent 8906851 expires

    Listed method-of-use patent (U-3190) expiration.

    in 23 d

  20. Patent 8906851 expires

    Listed method-of-use patent (U-3189) expiration.

    in 23 d

  21. Patent 8906851 expires

    Listed method-of-use patent (U-3188) expiration.

    in 23 d

  22. Patent 9884092 expires

    Listed method-of-use patent (U-2593) expiration.

    in 23 d

  23. Patent 9884092 expires

    Listed method-of-use patent (U-2594) expiration.

    in 23 d

  24. Patent 9884092 expires

    Listed method-of-use patent (U-2595) expiration.

    in 23 d

  25. Patent 9884092 expires

    Listed method-of-use patent (U-2596) expiration.

    in 23 d

  26. Patent 9884092 expires

    Listed method-of-use patent (U-2590) expiration.

    in 23 d

  27. Patent 9884092 expires

    Listed method-of-use patent (U-2588) expiration.

    in 23 d

  28. Patent 9884092 expires

    Listed method-of-use patent (U-2589) expiration.

    in 23 d

  29. Patent 9884092 expires

    Listed method-of-use patent (U-3190) expiration.

    in 23 d

  30. Patent 9884092 expires

    Listed method-of-use patent (U-3189) expiration.

    in 23 d

  31. Patent 9884092 expires

    Listed method-of-use patent (U-3188) expiration.

    in 23 d

  32. Patent 8329648*PED expires

    Listed listed patent expiration.

    in 7 mo

  33. Patent 8906851*PED expires

    Listed listed patent expiration.

    in 7 mo

  34. Patent 9884092*PED expires

    Listed listed patent expiration.

    in 7 mo

  35. Patent 8501698 expires

    Listed drug product patent expiration.

    in 11 mo

  36. Patent 8501698*PED expires

    Listed listed patent expiration.

    in 1 yr 5 mo

  37. Patent 8361972 expires

    Listed method-of-use patent (U-2588) expiration.

    in 1 yr 8 mo

  38. Patent 8361972*PED expires

    Listed listed patent expiration.

    in 2 yr 2 mo

Patent & exclusivity timeline

Protection horizon
20252026202720282029TodayPatent 6515117: 2025-10-04Patent 6515117Patent 6515117*PED: 2026-04-04Patent 6515117*PEDPatent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 8906851: 2026-08-18Patent 8906851Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 9884092: 2026-08-18Patent 9884092Patent 8329648*PED: 2027-02-18Patent 8329648*PEDPatent 8906851*PED: 2027-02-18Patent 8906851*PEDPatent 9884092*PED: 2027-02-18Patent 9884092*PEDPatent 8501698: 2027-06-20Patent 8501698Patent 8501698*PED: 2027-12-20Patent 8501698*PEDPatent 8361972: 2028-03-21Patent 8361972Patent 8361972*PED: 2028-09-21Patent 8361972*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

EXENATIDE SYNTHETIC

Strength

2MG/VIAL

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 022200

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
651511710 mo ago
SubstanceProductU-2588
6515117*PED4 mo ago
8329648in 23 d
U-2590
8329648in 23 d
U-2589
8329648in 23 d
U-2595
8329648in 23 d
U-2593
8329648in 23 d
U-2596
8329648in 23 d
U-2588
8329648in 23 d
U-2594
8329648in 23 d
U-3188
8329648in 23 d
U-3189
8329648in 23 d
U-3190
8906851in 23 d
U-2593
8906851in 23 d
U-2589
8906851in 23 d
U-2588
8906851in 23 d
U-2590
8906851in 23 d
U-3190
8906851in 23 d
U-3189
8906851in 23 d
U-3188
9884092in 23 d
U-2593
9884092in 23 d
U-2594
9884092in 23 d
U-2595
9884092in 23 d
U-2596
9884092in 23 d
U-2590
9884092in 23 d
U-2588
9884092in 23 d
U-2589
9884092in 23 d
U-3190
9884092in 23 d
U-3189
9884092in 23 d
U-3188
8329648*PEDin 7 mo
8906851*PEDin 7 mo
9884092*PEDin 7 mo
8501698in 11 mo
ProductU-2588
8501698*PEDin 1 yr 5 mo
8361972in 1 yr 8 mo
U-2588
8361972*PEDin 2 yr 2 mo

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 Exenatide Synthetic 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.

Bydureon: 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 022200 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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