The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Zyclara
imiquimod · IMIQUIMOD 2.5 mg/g · Cream · Topical · Bausch Health US, LLC
NDC 99207-0276-01 · 1 BOTTLE, PUMP in 1 CARTON / 7.5 g in 1 BOTTLE, PUMP · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →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 imiquimod (other) in the next 90 days
price up 19% YoY · 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
- manufacture
- Kindeva Drug Delivery LimitedUnited Kingdommanufacture
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 $1,278.67 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA022483
- TE code
- AB
- Approval date
- Mar 25, 2010
- Patents / exclusivity
- 10 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 10918635 | Apr 30, 2030 |
| patent | 11202752 | Apr 30, 2030 |
| patent | 11850245 | Apr 30, 2030 |
| patent | 8236816 | Dec 11, 2029 |
| patent | 10238644 | Dec 11, 2029 |
| patent | 11318130 | Dec 11, 2029 |
| patent | 8222270 | Dec 11, 2029 |
| patent | 8299109 | Dec 11, 2029 |
| patent | 8598196 | Aug 18, 2029 |
| patent | 10238645 | Aug 18, 2029 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of imiquimod (Cream)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bausch Health US, LLC | IMIQUIMOD 37.5 mg/g | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | IMIQUIMOD 12.5 mg/.25g | Jul 15, 2026 | Sep 3, 2026 |
| Bausch Health US, LLC | IMIQUIMOD 2.5 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Direct Rx | IMIQUIMOD 12.5 mg/.25g | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | IMIQUIMOD 50 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Oceanside Pharmacueticals | IMIQUIMOD 37.5 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Padagis Israel Pharmaceuticals Ltd | IMIQUIMOD 12.5 mg/.25g | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | IMIQUIMOD 37.5 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | IMIQUIMOD 50 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | IMIQUIMOD 37.5 mg/g | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Zyclara — NDC 99207-0276-01," retrieved September 3, 2026, https://drugdashboards.com/drug/99207027601.
Free to cite with attribution — see how the data is put together.