Hemin for Injection (Panhematin)
Hemin for Injection is an FDA-licensed reference biologic from Recordati Rare Diseases, Inc..
Reference product
Panhematin Hemin for Injection
Recordati Rare Diseases, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Reference approval
Approval date of the reference Hemin for Injection product.
43 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
36 yr 10 mo ago
Hemin for Injection: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Hemin for Injection.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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