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Orange Book drug · Brand (NDA)

Auvelity

Bupropion Hydrochloride; Dextromethorphan Hydrobromide

RLDNDA 215430 2 strengths Axsome
Approved
Aug 18, 2022
Strengths
2
Listed patents
145

What does the FDA Orange Book show for Auvelity?

Auvelity contains Bupropion Hydrochloride; Dextromethorphan Hydrobromide and is the new drug FDA Orange Book record for NDA 215430. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 215430

New drug application identity from the Orange Book snapshot.

Application holder
Axsome Therapeutics Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
145

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001105MG;45MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLDRS
002105MG;30MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Axsome Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 215430.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

145 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 20, 2043. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215430 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, Extended Release · Oral

Bupropion Hydrochloride; Dextromethorphan Hydrobromide

1 application
Product rows
2
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-215430

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · NDA 215430
RLDRS
Strength
105MG;45MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    4 yr ago

  2. Today

  3. Exclusivity ends · I-913

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    in 16 yr 9 mo

  190. Patent 11883373 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 9 mo

  191. Patent 12194005 expires

    Listed method-of-use patent (U-4523) expiration.

    in 16 yr 9 mo

  192. Patent 12364674 expires

    Listed method-of-use patent (U-4516) expiration.

    in 16 yr 9 mo

  193. Patent 11986444 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  194. Patent 12036191 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  195. Patent 12370154 expires

    Listed method-of-use patent (U-4518) expiration.

    in 16 yr 10 mo

  196. Patent 12599576 expires

    Listed method-of-use patent (U-4518) expiration.

    in 16 yr 10 mo

  197. Patent 11752144 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  198. Patent 12042473 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  199. Patent 12146889 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  200. Patent 12472155 expires

    Listed method-of-use patent (U-4519) expiration.

    in 16 yr 10 mo

  201. Patent 11839612 expires

    Listed method-of-use patent (U-3419) expiration.

    in 16 yr 10 mo

  202. Patent 11844797 expires

    Listed method-of-use patent (U-3778) expiration.

    in 17 yr

  203. Patent 12194036 expires

    Listed method-of-use patent (U-4521) expiration.

    in 17 yr

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038204020422044TodayExclusivity I-913: 2029-04-30Exclusivity I-913Patent 8569328: 2032-07-18Patent 8569328Patent 8569328: 2032-07-18Patent 8569328Patent 10058518: 2034-11-05Patent 10058518Patent 10058518: 2034-11-05Patent 10058518Patent 10064857: 2034-11-05Patent 10064857Patent 10064857: 2034-11-05Patent 10064857Patent 10080727: 2034-11-05Patent 10080727Patent 10092560: 2034-11-05Patent 10092560Patent 10092560: 2034-11-05Patent 10092560Patent 10092561: 2034-11-05Patent 10092561Patent 10092561: 2034-11-05Patent 10092561Patent 10105327: 2034-11-05Patent 10105327Patent 10105361: 2034-11-05Patent 10105361Patent 10251879: 2034-11-05Patent 10251879Patent 10463634: 2034-11-05Patent 10463634Patent 10512643: 2034-11-05Patent 10512643Patent 10548857: 2034-11-05Patent 10548857Patent 10596167: 2034-11-05Patent 10596167Patent 10596167: 2034-11-05Patent 10596167Patent 10772850: 2034-11-05Patent 10772850Patent 10780066: 2034-11-05Patent 10780066Patent 10780066: 2034-11-05Patent 10780066Patent 10786469: 2034-11-05Patent 10786469Patent 10786496: 2034-11-05Patent 10786496Patent 10786496: 2034-11-05Patent 10786496Patent 10799497: 2034-11-05Patent 10799497Patent 10806710: 2034-11-05Patent 10806710Patent 10806710: 2034-11-05Patent 10806710Patent 10864209: 2034-11-05Patent 10864209Patent 10874663: 2034-11-05Patent 10874663Patent 10874664: 2034-11-05Patent 10874664Patent 10874665: 2034-11-05Patent 10874665Patent 10881624: 2034-11-05Patent 10881624Patent 10881624: 2034-11-05Patent 10881624Patent 10881657: 2034-11-05Patent 10881657Patent 10894046: 2034-11-05Patent 10894046Patent 10894047: 2034-11-05Patent 10894047Patent 10898453: 2034-11-05Patent 10898453Patent 10933034: 2034-11-05Patent 10933034Patent 10945973: 2034-11-05Patent 10945973Patent 10966941: 2034-11-05Patent 10966941Patent 10966941: 2034-11-05Patent 10966941Patent 10966974: 2034-11-05Patent 10966974Patent 11007189: 2034-11-05Patent 11007189Patent 11020389: 2034-11-05Patent 11020389Patent 11058648: 2034-11-05Patent 11058648Patent 11065248: 2034-11-05Patent 11065248Patent 11065248: 2034-11-05Patent 11065248Patent 11090300: 2034-11-05Patent 11090300Patent 11096937: 2034-11-05Patent 11096937Patent 11123343: 2034-11-05Patent 11123343Patent 11123344: 2034-11-05Patent 11123344Patent 11123344: 2034-11-05Patent 11123344Patent 11129826: 2034-11-05Patent 11129826Patent 11141388: 2034-11-05Patent 11141388Patent 11141416: 2034-11-05Patent 11141416Patent 11147808: 2034-11-05Patent 11147808Patent 11185515: 2034-11-05Patent 11185515Patent 11191739: 2034-11-05Patent 11191739Patent 11191739: 2034-11-05Patent 11191739Patent 11197839: 2034-11-05Patent 11197839Patent 11197839: 2034-11-05Patent 11197839Patent 11207281: 2034-11-05Patent 11207281Patent 11207281: 2034-11-05Patent 11207281Patent 11213521: 2034-11-05Patent 11213521Patent 11229640: 2034-11-05Patent 11229640Patent 11234946: 2034-11-05Patent 11234946Patent 11234946: 2034-11-05Patent 11234946Patent 11253491: 2034-11-05Patent 11253491Patent 11253492: 2034-11-05Patent 11253492Patent 11253492: 2034-11-05Patent 11253492Patent 11273133: 2034-11-05Patent 11273133Patent 11273133: 2034-11-05Patent 11273133Patent 11273134: 2034-11-05Patent 11273134Patent 11273134: 2034-11-05Patent 11273134Patent 11285118: 2034-11-05Patent 11285118Patent 11285118: 2034-11-05Patent 11285118Patent 11285146: 2034-11-05Patent 11285146Patent 11285146: 2034-11-05Patent 11285146Patent 11291638: 2034-11-05Patent 11291638Patent 11291638: 2034-11-05Patent 11291638Patent 11291665: 2034-11-05Patent 11291665Patent 11291665: 2034-11-05Patent 11291665Patent 11298351: 2034-11-05Patent 11298351Patent 11298352: 2034-11-05Patent 11298352Patent 11298352: 2034-11-05Patent 11298352Patent 11311534: 2034-11-05Patent 11311534Patent 11344544: 2034-11-05Patent 11344544Patent 11344544: 2034-11-05Patent 11344544Patent 11357744: 2034-11-05Patent 11357744Patent 11357744: 2034-11-05Patent 11357744Patent 11364233: 2034-11-05Patent 11364233Patent 11382874: 2034-11-05Patent 11382874Patent 11382874: 2034-11-05Patent 11382874Patent 11419867: 2034-11-05Patent 11419867Patent 11419867: 2034-11-05Patent 11419867Patent 11426370: 2034-11-05Patent 11426370Patent 11426370: 2034-11-05Patent 11426370Patent 11426401: 2034-11-05Patent 11426401Patent 11426401: 2034-11-05Patent 11426401Patent 11433067: 2034-11-05Patent 11433067Patent 11433067: 2034-11-05Patent 11433067Patent 11439636: 2034-11-05Patent 11439636Patent 11439636: 2034-11-05Patent 11439636Patent 11478468: 2034-11-05Patent 11478468Patent 11497721: 2034-11-05Patent 11497721Patent 11510918: 2034-11-05Patent 11510918Patent 11517542: 2034-11-05Patent 11517542Patent 11517543: 2034-11-05Patent 11517543Patent 11524007: 2034-11-05Patent 11524007Patent 11524008: 2034-11-05Patent 11524008Patent 11534414: 2034-11-05Patent 11534414Patent 11534414: 2034-11-05Patent 11534414Patent 11541021: 2034-11-05Patent 11541021Patent 11541048: 2034-11-05Patent 11541048Patent 11571417: 2034-11-05Patent 11571417Patent 11571417: 2034-11-05Patent 11571417Patent 11576909: 2034-11-05Patent 11576909Patent 11576909: 2034-11-05Patent 11576909Patent 11590124: 2034-11-05Patent 11590124Patent 11590124: 2034-11-05Patent 11590124Patent 11596627: 2034-11-05Patent 11596627Patent 11617728: 2034-11-05Patent 11617728Patent 11617747: 2034-11-05Patent 11617747Patent 11779579: 2034-11-05Patent 11779579Patent 11969421: 2034-11-05Patent 11969421Patent 12109178: 2034-11-05Patent 12109178Patent 9168234: 2034-11-05Patent 9168234Patent 9168234: 2034-11-05Patent 9168234Patent 9198905: 2034-11-05Patent 9198905Patent 9198905: 2034-11-05Patent 9198905Patent 9205083: 2034-11-05Patent 9205083Patent 9205083: 2034-11-05Patent 9205083Patent 9238032: 2034-11-05Patent 9238032Patent 9278095: 2034-11-05Patent 9278095Patent 9278095: 2034-11-05Patent 9278095Patent 9314462: 2034-11-05Patent 9314462Patent 9314462: 2034-11-05Patent 9314462Patent 9370513: 2034-11-05Patent 9370513Patent 9370513: 2034-11-05Patent 9370513Patent 9375429: 2034-11-05Patent 9375429Patent 9408815: 2034-11-05Patent 9408815Patent 9421176: 2034-11-05Patent 9421176Patent 9421176: 2034-11-05Patent 9421176Patent 9457023: 2034-11-05Patent 9457023Patent 9457023: 2034-11-05Patent 9457023Patent 9457025: 2034-11-05Patent 9457025Patent 9457025: 2034-11-05Patent 9457025Patent 9474731: 2034-11-05Patent 9474731Patent 9474731: 2034-11-05Patent 9474731Patent 9486450: 2034-11-05Patent 9486450Patent 9486450: 2034-11-05Patent 9486450Patent 9700528: 2034-11-05Patent 9700528Patent 9700528: 2034-11-05Patent 9700528Patent 9700553: 2034-11-05Patent 9700553Patent 9700553: 2034-11-05Patent 9700553Patent 9707191: 2034-11-05Patent 9707191Patent 9707191: 2034-11-05Patent 9707191Patent 9763932: 2034-11-05Patent 9763932Patent 9763932: 2034-11-05Patent 9763932Patent 9861595: 2034-11-05Patent 9861595Patent 9861595: 2034-11-05Patent 9861595Patent 9867819: 2034-11-05Patent 9867819Patent 9867819: 2034-11-05Patent 9867819Patent 9968568: 2034-11-05Patent 9968568Patent 9968568: 2034-11-05Patent 9968568Patent 10780064: 2040-01-07Patent 10780064Patent 10925842: 2040-01-07Patent 10925842Patent 10940124: 2040-01-07Patent 10940124Patent 10966942: 2040-01-07Patent 10966942Patent 12433884: 2040-06-05Patent 12433884Patent 12472156: 2040-06-05Patent 12472156Patent 12576078: 2040-06-05Patent 12576078Patent 11896563: 2041-12-01Patent 11896563Patent 12390428: 2041-12-01Patent 12390428Patent 11717518: 2043-01-20Patent 11717518Patent 11925636: 2043-01-20Patent 11925636Patent 12156914: 2043-01-20Patent 12156914Patent 12239642: 2043-01-20Patent 12239642Patent 12263161: 2043-01-20Patent 12263161Patent 12310961: 2043-01-20Patent 12310961Patent 12357697: 2043-01-20Patent 12357697Patent 12472174: 2043-01-20Patent 12472174Patent 12478622: 2043-01-20Patent 12478622Patent 12564587: 2043-01-20Patent 12564587Patent 11730706: 2043-01-23Patent 11730706Patent 11883373: 2043-01-23Patent 11883373Patent 12194005: 2043-01-23Patent 12194005Patent 12364674: 2043-01-23Patent 12364674Patent 11986444: 2043-02-15Patent 11986444Patent 12036191: 2043-02-15Patent 12036191Patent 12370154: 2043-02-15Patent 12370154Patent 12599576: 2043-02-15Patent 12599576Patent 11752144: 2043-02-23Patent 11752144Patent 12042473: 2043-02-23Patent 12042473Patent 12146889: 2043-02-23Patent 12146889Patent 12472155: 2043-02-23Patent 12472155Patent 11839612: 2043-03-02Patent 11839612Patent 11844797: 2043-04-20Patent 11844797Patent 12194036: 2043-04-20Patent 12194036
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Strength

105MG;45MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 215430

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • I-913New indication exclusivity (3 years)

    in 2 yr 10 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8569328in 6 yr 1 mo
ProductU-3419
8569328in 6 yr 1 mo
ProductU-4516
10058518in 8 yr 5 mo
U-3419
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U-4522
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ProductU-3419
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ProductU-4516
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U-3419
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U-3419
12433884in 14 yr 1 mo
U-4514
12472156in 14 yr 1 mo
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11896563in 15 yr 7 mo
U-3419
12390428in 15 yr 7 mo
U-3419
11717518in 16 yr 9 mo
U-3419
11925636in 16 yr 9 mo
U-3419
12156914in 16 yr 9 mo
Product
12239642in 16 yr 9 mo
U-4515
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12310961in 16 yr 9 mo
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U-4521

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Bupropion Hydrochloride; Dextromethorphan Hydrobromide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Auvelity: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 215430 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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