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FDA Purple Book · Reference family

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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2017

Reference approved

Reference product

351(a)BLA 125592

Odactra House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract

ALK - Abello A/S

Approved
Mar 01, 2017
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract, in chronological order.

  1. Reference approval

    Approval date of the reference House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract product.

    9 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract (Odactra)?

No 351(k) biosimilars or interchangeable biosimilars referencing House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract are listed in the FDA Purple Book yet.

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