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Orange Book drug · Brand (NDA)

Xigduo XR

Dapagliflozin; Metformin Hydrochloride

RLDNDA 205649 5 strengths Astrazeneca Ab
Approved
Oct 29, 2014
Strengths
5
Listed patents
10

What does the FDA Orange Book show for Xigduo XR?

Xigduo XR contains Dapagliflozin; Metformin Hydrochloride and is the new drug FDA Orange Book record for NDA 205649. The application has 5 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 205649

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
5

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
10

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

Exclusivity records
2

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
0015MG;500MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
0025MG;1GMTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
00310MG;500MGTABLET, EXTENDED RELEASEORALPrescriptionAB
RLD
00410MG;1GMTABLET, EXTENDED RELEASEORALPrescriptionAB
RLDRS
0052.5MG;1GMTABLET, EXTENDED RELEASEORALPrescriptionAB
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 205649.

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

5 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

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

The latest future date recorded across those files is May 12, 2031. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

10 other ANDAs and 0 other NDAs found

10 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 205649 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-205649

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

5 approved presentations · NDA 205649
TE ABRLD
Strength
5MG;500MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 11 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. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 11 mo

  6. Patent 8501698 expires

    Listed drug product patent expiration.

    in 11 mo

  7. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 5 mo

  8. Patent 8501698*PED expires

    Listed listed patent expiration.

    in 1 yr 5 mo

  9. Patent 7919598 expires

    Listed drug substance patent expiration.

    in 3 yr 5 mo

  10. Patent 8685934 expires

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

    in 3 yr 11 mo

  11. Patent 7919598*PED expires

    Listed listed patent expiration.

    in 3 yr 11 mo

  12. Patent 9616028 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  13. Patent 8685934*PED expires

    Listed listed patent expiration.

    in 4 yr 5 mo

  14. Patent 9616028*PED expires

    Listed listed patent expiration.

    in 4 yr 10 mo

Patent & exclusivity timeline

Protection horizon
20252026202720282029203020312032TodayPatent 6515117: 2025-10-04Patent 6515117Patent 6515117*PED: 2026-04-04Patent 6515117*PEDExclusivity NPP: 2027-06-12Exclusivity NPPPatent 8501698: 2027-06-20Patent 8501698Exclusivity PED: 2027-12-12Exclusivity PEDPatent 8501698*PED: 2027-12-20Patent 8501698*PEDPatent 7919598: 2029-12-16Patent 7919598Patent 8685934: 2030-05-26Patent 8685934Patent 7919598*PED: 2030-06-16Patent 7919598*PEDPatent 9616028: 2030-11-12Patent 9616028Patent 8685934*PED: 2030-11-26Patent 8685934*PEDPatent 9616028*PED: 2031-05-12Patent 9616028*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Strength

5MG;500MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

NDA 205649

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • 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
6515117*PED4 mo ago
8501698in 11 mo
ProductU-493
8501698*PEDin 1 yr 5 mo
7919598in 3 yr 5 mo
Substance
8685934in 3 yr 11 mo
U-1522
7919598*PEDin 3 yr 11 mo
9616028in 4 yr 4 mo
Product
8685934*PEDin 4 yr 5 mo
9616028*PEDin 4 yr 10 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; Metformin Hydrochloride 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.

Xigduo XR: 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 205649 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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