The short version
12 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Xeljanz
tofacitinib · TOFACITINIB CITRATE 10 mg/1 · Tablet, Film Coated · Oral · U.S. Pharmaceuticals
NDC 63539-0016-02 · 60 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00069-1002-01) — 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ⓘ
$105.08per unit
middle half $101.43–$108.33 · 3,385 plans · Apr 1, 2026
Est. net of rebatesⓘ
$63.05–$78.81
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
62%of plans cover it
tier 5 · prior auth 97% · step therapy 0% · qty limit 92%
*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 tofacitinib (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
- Pfizer Asia Manufacturing Pte LtdSingaporeanalysis · api manufacture
- analysis
- analysis · api manufacture
- analysis · label · manufacture · pack
- Viatris Pharmaceuticals LLCUnited Statesanalysis · label · 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 $5,630.23 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA203214
- TE code
- AB
- Approval date
- Nov 6, 2012
- Patents / exclusivity
- 4 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PED | Aug 21, 2028 |
| exclusivity | M-14 | Feb 21, 2028 |
| patent | RE41783*PED | Jun 8, 2026 |
| patent | RE41783*PED | Jun 8, 2026 |
| patent | RE41783 | Dec 8, 2025 |
| patent | RE41783 | Dec 8, 2025 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of tofacitinib (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Apotex Corp. | TOFACITINIB 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | TOFACITINIB 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Micro Labs Limited | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Micro Labs Limited | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Pfizer Laboratories Div Pfizer Inc | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Pfizer Laboratories Div Pfizer Inc | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Somerset Therapeutics, LLC | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Somerset Therapeutics, LLC | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| U.S. Pharmaceuticals | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| U.S. Pharmaceuticals | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | TOFACITINIB CITRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | TOFACITINIB CITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | TOFACITINIB CITRATE 5 mg/1 | Jul 25, 2026 | Aug 29, 2026 |
| AvKARE | TOFACITINIB CITRATE 10 mg/1 | Jul 25, 2026 | Aug 29, 2026 |
| Golden State Medical Supply, Inc. | TOFACITINIB 5 mg/1 | Aug 15, 2026 | Aug 29, 2026 |
| Golden State Medical Supply, Inc. | TOFACITINIB 10 mg/1 | Aug 15, 2026 | Aug 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Xeljanz — NDC 63539-0016-02," retrieved September 3, 2026, https://drugdashboards.com/drug/63539001602.
Free to cite with attribution — see how the data is put together.