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Orange Book drug · Brand (NDA)

Synjardy

Empagliflozin; Metformin Hydrochloride

RLDNDA 206111 4 strengths Boehringer Ingelheim
Approved
Aug 26, 2015
Strengths
4
Listed patents
25

What does the FDA Orange Book show for Synjardy?

Synjardy contains Empagliflozin; Metformin Hydrochloride and is the new drug FDA Orange Book record for NDA 206111. The application has 4 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 206111

New drug application identity from the Orange Book snapshot.

Application holder
Boehringer Ingelheim Pharmaceuticals Inc

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

Product presentations
4

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
25

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;500MGTABLETORALPrescriptionNone posted
RLD
0025MG;1GMTABLETORALPrescriptionNone posted
RLD
00312.5MG;500MGTABLETORALPrescriptionNone posted
RLD
00412.5MG;1GMTABLETORALPrescriptionNone 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

Boehringer Ingelheim Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 206111.

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

4 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

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

The latest future date recorded across those files is Nov 17, 2034. 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 1 other NDA 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 206111 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-206111

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

4 approved presentations · NDA 206111
RLD
Strength
5MG;500MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 1 mo ago

  2. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    1 mo ago

  3. Today

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 5 mo

  5. Patent 7713938 expires

    Listed drug substance patent expiration.

    in 9 mo

  6. Patent 7713938*PED expires

    Listed listed patent expiration.

    in 1 yr 3 mo

  7. Patent 7579449 expires

    Listed drug substance patent expiration.

    in 2 yr 1 mo

  8. Patent 7579449*PED expires

    Listed listed patent expiration.

    in 2 yr 7 mo

  9. Patent 12115179 expires

    Listed method-of-use patent (U-4023) expiration.

    in 3 yr 7 mo

  10. Patent 12115179*PED expires

    Listed listed patent expiration.

    in 4 yr 1 mo

  11. Patent 10610489 expires

    Listed drug product patent expiration.

    in 4 yr 3 mo

  12. Patent 10610489*PED expires

    Listed listed patent expiration.

    in 4 yr 9 mo

  13. Patent 12527810 expires

    Listed method-of-use patent (U-4403) expiration.

    in 6 yr 10 mo

  14. Patent 12527810*PED expires

    Listed listed patent expiration.

    in 7 yr 4 mo

  15. Patent 10258637 expires

    Listed method-of-use patent (U-2290) expiration.

    in 7 yr 10 mo

  16. Patent 11090323 expires

    Listed method-of-use patent (U-3193) expiration.

    in 7 yr 10 mo

  17. Patent 11666590 expires

    Listed method-of-use patent (U-4154) expiration.

    in 7 yr 10 mo

  18. Patent 11813275 expires

    Listed method-of-use patent (U-3759) expiration.

    in 7 yr 10 mo

  19. Patent 11833166 expires

    Listed method-of-use patent (U-3776) expiration.

    in 7 yr 10 mo

  20. Patent 11833166 expires

    Listed method-of-use patent (U-3777) expiration.

    in 7 yr 10 mo

  21. Patent 12263153 expires

    Listed method-of-use patent (U-4154) expiration.

    in 7 yr 10 mo

  22. Patent 12427162 expires

    Listed method-of-use patent (U-4287) expiration.

    in 7 yr 10 mo

  23. Patent 12433906 expires

    Listed method-of-use patent (U-4304) expiration.

    in 7 yr 10 mo

  24. Patent 12433906 expires

    Listed method-of-use patent (U-4293) expiration.

    in 7 yr 10 mo

  25. Patent 12433906 expires

    Listed method-of-use patent (U-4294) expiration.

    in 7 yr 10 mo

  26. Patent 12433906 expires

    Listed method-of-use patent (U-4295) expiration.

    in 7 yr 10 mo

  27. Patent 12433906 expires

    Listed method-of-use patent (U-4296) expiration.

    in 7 yr 10 mo

  28. Patent 9949997 expires

    Listed method-of-use patent (U-3532) expiration.

    in 7 yr 11 mo

  29. Patent 9949997 expires

    Listed method-of-use patent (U-3533) expiration.

    in 7 yr 11 mo

  30. Patent 10258637*PED expires

    Listed listed patent expiration.

    in 8 yr 4 mo

  31. Patent 11090323*PED expires

    Listed listed patent expiration.

    in 8 yr 4 mo

  32. Patent 11813275*PED expires

    Listed listed patent expiration.

    in 8 yr 4 mo

  33. Patent 11833166*PED expires

    Listed listed patent expiration.

    in 8 yr 4 mo

  34. Patent 12433906*PED expires

    Listed listed patent expiration.

    in 8 yr 4 mo

  35. Patent 9949997*PED expires

    Listed listed patent expiration.

    in 8 yr 5 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayExclusivity NPP: 2026-06-20Exclusivity NPPExclusivity PED: 2026-12-20Exclusivity PEDPatent 7713938: 2027-04-15Patent 7713938Patent 7713938*PED: 2027-10-15Patent 7713938*PEDPatent 7579449: 2028-08-01Patent 7579449Patent 7579449*PED: 2029-02-01Patent 7579449*PEDPatent 12115179: 2030-02-11Patent 12115179Patent 12115179*PED: 2030-08-11Patent 12115179*PEDPatent 10610489: 2030-09-30Patent 10610489Patent 10610489*PED: 2031-03-30Patent 10610489*PEDPatent 12527810: 2033-04-22Patent 12527810Patent 12527810*PED: 2033-10-22Patent 12527810*PEDPatent 10258637: 2034-04-03Patent 10258637Patent 11090323: 2034-04-03Patent 11090323Patent 11666590: 2034-04-03Patent 11666590Patent 11813275: 2034-04-03Patent 11813275Patent 11833166: 2034-04-03Patent 11833166Patent 11833166: 2034-04-03Patent 11833166Patent 12263153: 2034-04-03Patent 12263153Patent 12427162: 2034-04-03Patent 12427162Patent 12433906: 2034-04-03Patent 12433906Patent 12433906: 2034-04-03Patent 12433906Patent 12433906: 2034-04-03Patent 12433906Patent 12433906: 2034-04-03Patent 12433906Patent 12433906: 2034-04-03Patent 12433906Patent 9949997: 2034-05-17Patent 9949997Patent 9949997: 2034-05-17Patent 9949997Patent 10258637*PED: 2034-10-03Patent 10258637*PEDPatent 11090323*PED: 2034-10-03Patent 11090323*PEDPatent 11813275*PED: 2034-10-03Patent 11813275*PEDPatent 11833166*PED: 2034-10-03Patent 11833166*PEDPatent 12433906*PED: 2034-10-03Patent 12433906*PEDPatent 9949997*PED: 2034-11-17Patent 9949997*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Strength

5MG;500MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 206111

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)

    1 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    in 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
7713938in 9 mo
SubstanceProduct
7713938*PEDin 1 yr 3 mo
7579449in 2 yr 1 mo
Substance
7579449*PEDin 2 yr 7 mo
12115179in 3 yr 7 mo
U-4023
12115179*PEDin 4 yr 1 mo
10610489in 4 yr 3 mo
Product
10610489*PEDin 4 yr 9 mo
12527810in 6 yr 10 mo
U-4403
12527810*PEDin 7 yr 4 mo
10258637in 7 yr 10 mo
U-2290
11090323in 7 yr 10 mo
U-3193
11666590in 7 yr 10 mo
U-4154
11813275in 7 yr 10 mo
U-3759
11833166in 7 yr 10 mo
U-3776
11833166in 7 yr 10 mo
U-3777
12263153in 7 yr 10 mo
U-4154
12427162in 7 yr 10 mo
U-4287
12433906in 7 yr 10 mo
U-4304
12433906in 7 yr 10 mo
U-4293
12433906in 7 yr 10 mo
U-4294
12433906in 7 yr 10 mo
U-4295
12433906in 7 yr 10 mo
U-4296
9949997in 7 yr 11 mo
U-3532
9949997in 7 yr 11 mo
U-3533
10258637*PEDin 8 yr 4 mo
11090323*PEDin 8 yr 4 mo
11813275*PEDin 8 yr 4 mo
11833166*PEDin 8 yr 4 mo
12433906*PEDin 8 yr 4 mo
9949997*PEDin 8 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 Empagliflozin; 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.

Synjardy: 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 206111 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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