Purple Book product · Reference 351(a)

Natpara

parathyroid hormone

351(a)BLA 125511RxLicensed Takeda Pharmaceuticals U.S.A., Inc.

View parathyroid hormone family Label PDF Open on FDA Purple Book

Jan 23, 2015

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Natpara (parathyroid hormone) is Takeda Pharmaceuticals U.S.A., Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2015. No biosimilars referencing Natpara are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Jan 23, 2015
11 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jan 23, 2022
4 yr 7 mo ago
Today

Pharmaceutical detail

Strength

100MCG

Dosage form

For Injection

Route

Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

1898

Product number

004

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

3 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Natpara have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Natpara are listed in the FDA Purple Book yet.

What is Natpara's BLA number?

Natpara is licensed under BLA 125511, held by Takeda Pharmaceuticals U.S.A., Inc..

When was Natpara approved by the FDA?

Natpara was approved by the FDA on Jan 23, 2015.

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