The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Synjardy
empagliflozin and metformin hydrochloride · EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 · Tablet · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC 00597-0168-66 · 1 BOTTLE in 1 CARTON / 14 TABLET in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00597-0168-60) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$5.61per unit
middle half $5.54–$5.93 · 3,605 plans · Apr 1, 2026
Est. net of rebatesⓘ
$3.37–$4.21
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
66%of plans cover it
tier 3 · prior auth 0% · step therapy 1% · qty limit 96%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for empagliflozin and metformin hydrochloride (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- api manufacture · label · manufacture · pack
- label · manufacture · pack
- Patheon Puerto Rico, Inc.United Stateslabel · manufacture · pack
- Sixarp, LLCUnited Stateslabel · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $961.84 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA206111
- TE code
- —
- Approval date
- Aug 26, 2015
- Patents / exclusivity
- 96 patents, 8 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PED | Dec 20, 2026 |
| exclusivity | PED | Dec 20, 2026 |
| exclusivity | PED | Dec 20, 2026 |
| exclusivity | PED | Dec 20, 2026 |
| exclusivity | NPP | Jun 20, 2026 |
| exclusivity | NPP | Jun 20, 2026 |
| exclusivity | NPP | Jun 20, 2026 |
| exclusivity | NPP | Jun 20, 2026 |
| patent | 9949997*PED | Nov 17, 2034 |
| patent | 9949997*PED | Nov 17, 2034 |
| patent | 9949997*PED | Nov 17, 2034 |
| patent | 9949997*PED | Nov 17, 2034 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedSep 4, 2018Boehringer Ingelheim Pharmaceuticals, Inc. — Cross Contamination With Other Products:
Manufacturers of empagliflozin and metformin hydrochloride (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | EMPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | EMPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 850 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Puerto Rico, Inc. | EMPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 850 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Synjardy — NDC 00597-0168-66," retrieved September 3, 2026, https://drugdashboards.com/drug/00597016866.
Free to cite with attribution — see how the data is put together.