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FDA Orange Book · active-ingredient family

Bupropion hydrobromide

Bupropion hydrobromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:APLENZIN · NDA 022108

1

Brand (NDA)

0

Generics (ANDA)

8

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, extended release

ProductApplicantApplicationTEApproved
APLENZINRLD×3BAUSCHNDA 022108Apr 23, 2008

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7569610Jun 27, 2026in 8 d
U-997
7241805Jun 27, 2026in 8 d
Product
7645802Jun 27, 2026in 8 d
Product
7585897Jun 27, 2026in 8 d
Product
7662407Jun 27, 2026in 8 d
Product
7572935Jun 27, 2026in 8 d
Product
7649019Jun 27, 2026in 8 d
Product
7671094Jun 27, 2026in 8 d
Product

Bupropion hydrobromide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.