Purple Book product · Reference 351(a)
Genotropin
somatropin
Jan 27, 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.
Jan 27, 1998
28 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 25, 2008
18 yr 3 mo ago
Today
Pharmaceutical detail
Strength
1.2MG
Dosage form
For Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1216
Product number
009
Submission type
Supplement
Supplement number
9
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.
12 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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Genotropin have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Genotropin are listed in the FDA Purple Book yet.
What is Genotropin's BLA number?
Genotropin is licensed under BLA 20280, held by Pharmacia & Upjohn Company LLC.
When was Genotropin approved by the FDA?
Genotropin was approved by the FDA on Jan 27, 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.
