Talzenna

talazoparib · TALAZOPARIB TOSYLATE 1 mg/1 · Capsule · Oral · U.S. Pharmaceuticals

NDC 63539-0295-30 · 1 BOTTLE in 1 CARTON / 30 CAPSULE in 1 BOTTLE · NDA · View full market →

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.

Medicare Part D

Matched to CMS's representative package for this drug (NDC 00069-1195-30) — 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ⓘ

$638.95per unit

middle half $613.24–$667.71 · 5,652 plans · Jan 1, 2025

Est. net of rebatesⓘ

$383.37–$479.21

brand drug — est. 25-40% rebate off the price at left

Coverage & restrictions

—of plans cover it

*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 5 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.

Where it's made

Pharmacia & Upjohn Company LLCUnited States
label · pack
SGS Institut Fresenius GmbHGermany
analysis
Sharp Packaging Services, LLCUnited States
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 $15,996.21 per prescription
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: NDA211651
TE code: —
Approval date: Oct 16, 2018
Patents / exclusivity: 34 patents, 3 exclusivities

Type	Number / code	Expires
exclusivity	I-920	Jun 20, 2026
exclusivity	I-920	Jun 20, 2026
exclusivity	I-920	Jun 20, 2026
patent	8735392	Oct 20, 2031
patent	8735392	Oct 20, 2031
patent	8735392	Oct 20, 2031
patent	8735392	Oct 20, 2031
patent	10189837	Oct 20, 2031
patent	10189837	Oct 20, 2031
patent	8735392	Oct 20, 2031
patent	10189837	Oct 20, 2031
patent	8735392	Oct 20, 2031

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of talazoparib (Capsule)

Labeler	Strength	First seen	Last seen
Pfizer Laboratories Div Pfizer Inc	TALAZOPARIB TOSYLATE .25 mg/1	Jul 15, 2026	Sep 2, 2026
Pfizer Laboratories Div Pfizer Inc	TALAZOPARIB TOSYLATE .5 mg/1	Jul 15, 2026	Sep 2, 2026
Pfizer Laboratories Div Pfizer Inc	TALAZOPARIB TOSYLATE 1 mg/1	Jul 15, 2026	Sep 2, 2026
U.S. Pharmaceuticals	TALAZOPARIB TOSYLATE 1 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, "Talzenna — NDC 63539-0295-30," retrieved September 3, 2026, https://drugdashboards.com/drug/63539029530.

Free to cite with attribution — see how the data is put together.