The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Bijuva
estradiol and progesterone · ESTRADIOL .5 mg/1; PROGESTERONE 100 mg/1 · Capsule · Oral · Mayne Pharma LLC
NDC 50261-0251-05 · 1 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 68308-0751-30) — 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ⓘ
$8.37per unit
middle half $8.35–$8.80 · 289 plans · Apr 1, 2026
Est. net of rebatesⓘ
$5.02–$6.27
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
5%of plans cover it
tier 3 · prior auth 93% · step therapy 0% · qty limit 0%
*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 9 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 estradiol and progesterone (oral solid) in the next 90 days
sole-source market · price up 5% YoY
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
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA210132
- TE code
- —
- Approval date
- Oct 28, 2018
- Patents / exclusivity
- 39 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 10206932 | Nov 21, 2032 |
| patent | 8846649 | Nov 21, 2032 |
| patent | 8846648 | Nov 21, 2032 |
| patent | 9114146 | Nov 21, 2032 |
| patent | 9114145 | Nov 21, 2032 |
| patent | 10675288 | Nov 21, 2032 |
| patent | 9301920 | Nov 21, 2032 |
| patent | 11033626 | Nov 21, 2032 |
| patent | 9006222 | Nov 21, 2032 |
| patent | 10806740 | Nov 21, 2032 |
| patent | 11103513 | Nov 21, 2032 |
| patent | 11793819 | Nov 21, 2032 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of estradiol and progesterone (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Catalent Pharma Solutions, LLC | ESTRADIOL .5 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | ESTRADIOL 1 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mayne Pharma | ESTRADIOL .5 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Mayne Pharma | ESTRADIOL 1 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Mayne Pharma LLC | ESTRADIOL .5 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Mayne Pharma LLC | ESTRADIOL 1 mg/1; PROGESTERONE 100 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Bijuva — NDC 50261-0251-05," retrieved September 3, 2026, https://drugdashboards.com/drug/50261025105.
Free to cite with attribution — see how the data is put together.