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Orange Book drug · Brand (NDA)

Farxiga

Dapagliflozin

RLDNDA 202293 2 strengths Astrazeneca Ab
Approved
Jan 08, 2014
Strengths
2
Listed patents
34

What does the FDA Orange Book show for Farxiga?

Farxiga contains Dapagliflozin and is the new drug FDA Orange Book record for NDA 202293. The application has 2 presentations 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 202293

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
2

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
AB

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

Listed patents
34

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

Exclusivity records
4

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
0015MGTABLETORALPrescriptionAB
RLD
00210MGTABLETORALPrescriptionAB
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

Astrazeneca Ab

The Orange Book identifies this organization as the applicant responsible for NDA 202293.

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

2 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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

32 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 01, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

15 other ANDAs and 0 other NDAs found

15 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 202293 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-202293

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

2 approved presentations · NDA 202293
TE ABRLD
Strength
5MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 9 mo ago

  2. Patent 6515117 expires

    Listed drug substance patent expiration.

    10 mo ago

  3. Patent 6515117 expires

    Listed drug substance patent expiration.

    10 mo ago

  4. Patent 6515117*PED expires

    Listed listed patent expiration.

    4 mo ago

  5. Exclusivity ends · M-298

    New use / labeling-change exclusivity (3 years)

    3 mo ago

  6. Today

  7. Patent 8329648 expires

    Listed method-of-use patent (U-2213) expiration.

    in 23 d

  8. Patent 8329648 expires

    Listed method-of-use patent (U-2139) expiration.

    in 23 d

  9. Patent 8329648 expires

    Listed method-of-use patent (U-2212) expiration.

    in 23 d

  10. Patent 8906851 expires

    Listed method-of-use patent (U-2139) expiration.

    in 23 d

  11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 4 mo

  12. Patent 8329648*PED expires

    Listed listed patent expiration.

    in 7 mo

  13. Patent 8906851*PED expires

    Listed listed patent expiration.

    in 7 mo

  14. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 11 mo

  15. Patent 8501698 expires

    Listed drug product patent expiration.

    in 11 mo

  16. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 5 mo

  17. Patent 8501698*PED expires

    Listed listed patent expiration.

    in 1 yr 5 mo

  18. Patent 8221786 expires

    Listed drug product patent expiration.

    in 1 yr 8 mo

  19. Patent 8361972 expires

    Listed method-of-use patent (U-2139) expiration.

    in 1 yr 8 mo

  20. Patent 8361972 expires

    Listed method-of-use patent (U-493) expiration.

    in 1 yr 8 mo

  21. Patent 8716251 expires

    Listed drug product patent expiration.

    in 1 yr 8 mo

  22. Patent 7851502 expires

    Listed drug product patent expiration.

    in 2 yr 1 mo

  23. Patent 8221786*PED expires

    Listed listed patent expiration.

    in 2 yr 2 mo

  24. Patent 8361972*PED expires

    Listed listed patent expiration.

    in 2 yr 2 mo

  25. Patent 8716251*PED expires

    Listed listed patent expiration.

    in 2 yr 2 mo

  26. Patent 7851502*PED expires

    Listed listed patent expiration.

    in 2 yr 7 mo

  27. Patent 7919598 expires

    Listed drug substance patent expiration.

    in 3 yr 5 mo

  28. Patent 8721615 expires

    Listed drug product patent expiration.

    in 3 yr 6 mo

  29. Patent 8685934 expires

    Listed method-of-use patent (U-1522) expiration.

    in 3 yr 11 mo

  30. Patent 7919598*PED expires

    Listed listed patent expiration.

    in 3 yr 11 mo

  31. Patent 8721615*PED expires

    Listed listed patent expiration.

    in 4 yr

  32. Patent 8685934*PED expires

    Listed listed patent expiration.

    in 4 yr 5 mo

Patent & exclusivity timeline

Protection horizon
2025202620272028202920302031TodayPatent 6515117: 2025-10-04Patent 6515117Patent 6515117: 2025-10-04Patent 6515117Patent 6515117*PED: 2026-04-04Patent 6515117*PEDExclusivity M-298: 2026-05-08Exclusivity M-298Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8329648: 2026-08-18Patent 8329648Patent 8906851: 2026-08-18Patent 8906851Exclusivity PED: 2026-11-08Exclusivity PEDPatent 8329648*PED: 2027-02-18Patent 8329648*PEDPatent 8906851*PED: 2027-02-18Patent 8906851*PEDExclusivity NPP: 2027-06-12Exclusivity NPPPatent 8501698: 2027-06-20Patent 8501698Exclusivity PED: 2027-12-12Exclusivity PEDPatent 8501698*PED: 2027-12-20Patent 8501698*PEDPatent 8221786: 2028-03-21Patent 8221786Patent 8361972: 2028-03-21Patent 8361972Patent 8361972: 2028-03-21Patent 8361972Patent 8716251: 2028-03-21Patent 8716251Patent 7851502: 2028-08-19Patent 7851502Patent 8221786*PED: 2028-09-21Patent 8221786*PEDPatent 8361972*PED: 2028-09-21Patent 8361972*PEDPatent 8716251*PED: 2028-09-21Patent 8716251*PEDPatent 7851502*PED: 2029-02-19Patent 7851502*PEDPatent 7919598: 2029-12-16Patent 7919598Patent 8721615: 2030-01-18Patent 8721615Patent 8685934: 2030-05-26Patent 8685934Patent 7919598*PED: 2030-06-16Patent 7919598*PEDPatent 8721615*PED: 2030-07-18Patent 8721615*PEDPatent 8685934*PED: 2030-11-26Patent 8685934*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DAPAGLIFLOZIN

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 202293

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • M-298New use / labeling-change exclusivity (3 years)

    3 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    in 4 mo

  • NPPNew patient population exclusivity (3 years)

    in 11 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 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
651511710 mo ago
SubstanceProductU-493
651511710 mo ago
SubstanceProductU-2139
6515117*PED4 mo ago
8329648in 23 d
U-2213
8329648in 23 d
U-2139
8329648in 23 d
U-2212
8906851in 23 d
U-2139
8329648*PEDin 7 mo
8906851*PEDin 7 mo
8501698in 11 mo
ProductU-493
8501698*PEDin 1 yr 5 mo
8221786in 1 yr 8 mo
Product
8361972in 1 yr 8 mo
U-2139
8361972in 1 yr 8 mo
U-493
8716251in 1 yr 8 mo
Product
7851502in 2 yr 1 mo
Product
8221786*PEDin 2 yr 2 mo
8361972*PEDin 2 yr 2 mo
8716251*PEDin 2 yr 2 mo
7851502*PEDin 2 yr 7 mo
7919598in 3 yr 5 mo
Substance
8721615in 3 yr 6 mo
ProductDelisted
8685934in 3 yr 11 mo
U-1522
7919598*PEDin 3 yr 11 mo
8721615*PEDin 4 yr
8685934*PEDin 4 yr 5 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 Dapagliflozin 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.

Farxiga: 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 202293 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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