Purple Book product · Reference 351(a)
Gonal-f
follitropin alfa
Feb 28, 2001
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.
Feb 28, 2001
25 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 24, 2007
19 yr 5 mo ago
Today
Pharmaceutical detail
Strength
1,050IU (600IU/ML)
Dosage form
For Injection
Route
Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
1773
Product number
004
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.
4 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
- advanced-searchAdvanced Search · Jul 02, 2026
Change history
- v2Jul 02, 2026
Frequently asked questions
Does Gonal-f have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Gonal-f are listed in the FDA Purple Book yet.
What is Gonal-f's BLA number?
Gonal-f is licensed under BLA 020378, held by EMD Serono, Inc..
When was Gonal-f approved by the FDA?
Gonal-f was approved by the FDA on Feb 28, 2001.
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.
