Purple Book product · Reference 351(a)
Gonal-f
follitropin alfa
Sep 29, 1997
Approved
Reference 351(a)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Sep 29, 1997
29 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 24, 2007
19 yr 5 mo ago
Today
Pharmaceutical detail
Strength
75IU
Dosage form
For Injection
Route
Subcutaneous
Presentation
Ampule
Center
CDER
License number
1773
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.
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 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 20378, held by EMD Serono, Inc..
When was Gonal-f approved by the FDA?
Gonal-f was approved by the FDA on Sep 29, 1997.
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.
