Purple Book product · Reference 351(a)
Thyrogen
thyrotropin alfa
Nov 30, 1998
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Nov 30, 1998
28 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 14, 2014
11 yr 9 mo ago
Today
Pharmaceutical detail
Strength
0.9MG
Dosage form
For Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CDER
License number
1596
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v1Jul 02, 2026
Frequently asked questions
Does Thyrogen have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Thyrogen are listed in the FDA Purple Book yet.
What is Thyrogen's BLA number?
Thyrogen is licensed under BLA 20898, held by Genzyme Corporation.
When was Thyrogen approved by the FDA?
Thyrogen was approved by the FDA on Nov 30, 1998.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
