bupropion hydrochloride; dextromethorphan hydrobromide · Axsome · NDA 215430

Auvelity

Earliest generic entry, as listed · earliest of 2 marketed strengths
20 Jan 2043

Other strengths are listed to 28 Nov 2043.

Blocked by patent: US 11717518, US 11925636, US 12156914, US 12239642, US 12263161, US 12310961, US 12357697, US 12472174, US 12478622, US 12564587, US 12661408, US 12678506.

Listed patents · 212 unexpired

PatentClaimsExpires
US 12653795use U-451628 Nov 2043
US 11844797use U-377820 Apr 2043
US 12194036use U-452120 Apr 2043
US 11839612use U-34192 Mar 2043
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US 12156914product20 Jan 2043
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US 12678506product20 Jan 2043
US 11896563use U-34191 Dec 2041
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US 11433067product, use U-45165 Nov 2034
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US 11534414product, use U-34195 Nov 2034
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US 9474731use U-45205 Nov 2034
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US 9700528use U-45175 Nov 2034
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US 9707191use U-34195 Nov 2034
US 9763932use U-45175 Nov 2034
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US 9861595use U-45175 Nov 2034
US 9867819use U-34195 Nov 2034
US 9867819use U-45175 Nov 2034
US 9968568use U-45175 Nov 2034
US 9968568use U-34195 Nov 2034
US 8569328product, use U-341918 Jul 2032
US 8569328product, use U-451618 Jul 2032

Exclusivities · 1 unexpired

I-913new indication (3 years)30 Apr 2029

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 2

NDA · productFormStrengthListed expiry
215430 · 001 · RLDtablet, extended release, oral105MG;45MG28 Nov 2043
215430 · 002 · RLDtablet, extended release, oral105MG;30MG20 Jan 2043