Purple Book reference family · 351(a) biologic
House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract (Odactra)
House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract is an FDA-licensed reference biologic from ALK - Abello A/S.
351(a) biologicBLA 125592 ALK - Abello A/S
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 125592
Odactra House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract
ALK - Abello A/S
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract product.
9 yr 6 mo ago
House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract: 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 House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract.
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