Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)
Rho(D) Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from CSL Behring AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
Rhophylac Rho(D) Immune Globulin Intravenous (Human)
CSL Behring AG
- Approved
- Feb 12, 2004
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Rho(D) Immune Globulin Intravenous (Human), in chronological order.
Reference approval
Approval date of the reference Rho(D) Immune Globulin Intravenous (Human) product.
22 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)?
No 351(k) biosimilars or interchangeable biosimilars referencing Rho(D) Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.