Alphanine, Alphanine Hp, Alphanine Sd

At a glance

Key dates

1. Approval

   Approval date of this BLA submission.

   Dec 31, 1990

   35 yr 11 mo ago

2. Orphan exclusivity ends

   7-year orphan-drug exclusivity window.

   Dec 31, 1997

   28 yr 10 mo ago

3. Today

Pharmaceutical detail

This is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.

• Alphanine, Alphanine Hp, Alphanine SdReference 351(a)

  Coagulation Factor IX (Human) · Grifols Biologicals LLC

  1990
• Alphanine, Alphanine Hp, Alphanine SdReference 351(a)

  Coagulation Factor IX (Human) · Grifols Biologicals LLC

  1990
• Alphanine, Alphanine Hp, Alphanine SdReference 351(a)

  Coagulation Factor IX (Human) · Grifols Biologicals LLC

  1990

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.

• Food and Drug Administrationparent ofCenter for Biologics Evaluation and Research
• Food and Drug Administrationsource forMonthly Download
• Biologics License Applicationparent ofSection 351(a) Biologic
• Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
• Section 351(a) Biologicmaps to351(a)
• 351(a)classifiesReference or Standalone Biologic

Source provenance