Assyro AI

Orange Book product · Brand (NDA)

AUVELITY

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Brand (NDA)NDA 215430RX AXSOME
View BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE familyOpen on FDA Orange Book

At a glance

Apr 30, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

49

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 30, 2026

    2 mo ago

  2. Today

  3. Exclusivity ends · I-913

    New indication exclusivity (3 years)

    Apr 30, 2029

    in 2 yr 11 mo

  4. Patent 8569328 expires

    Listed drug product patent expiration.

    Jul 18, 2032

    in 6 yr 2 mo

  5. Patent 10058518 expires

    Listed method-of-use patent (U-4522) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  6. Patent 10080727 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  7. Patent 10092560 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  8. Patent 10105361 expires

    Listed method-of-use patent (U-4522) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  9. Patent 10251879 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  10. Patent 10780066 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  11. Patent 11007189 expires

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

    Nov 05, 2034

    in 8 yr 6 mo

  12. Patent 11207281 expires

    Listed method-of-use patent (U-4537) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  13. Patent 11234946 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  14. Patent 11253492 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  15. Patent 11273133 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  16. Patent 11273134 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  17. Patent 11285118 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  18. Patent 11285146 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  19. Patent 11291638 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  20. Patent 11291665 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  21. Patent 11298352 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  22. Patent 11344544 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  23. Patent 11382874 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  24. Patent 11419867 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  25. Patent 11426370 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  26. Patent 11571417 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  27. Patent 11590124 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  28. Patent 11617747 expires

    Listed method-of-use patent (U-4526) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  29. Patent 9168234 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  30. Patent 9198905 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  31. Patent 9205083 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  32. Patent 9238032 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  33. Patent 9314462 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  34. Patent 9370513 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  35. Patent 9375429 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  36. Patent 9408815 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  37. Patent 9421176 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  38. Patent 9457023 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  39. Patent 9457025 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  40. Patent 9474731 expires

    Listed method-of-use patent (U-4520) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  41. Patent 9486450 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  42. Patent 9700528 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  43. Patent 9700553 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  44. Patent 9707191 expires

    Listed method-of-use patent (U-4522) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  45. Patent 9763932 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  46. Patent 9861595 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  47. Patent 9867819 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  48. Patent 9968568 expires

    Listed method-of-use patent (U-4517) expiration.

    Nov 05, 2034

    in 8 yr 6 mo

  49. Patent 12433884 expires

    Listed method-of-use patent (U-4514) expiration.

    Jun 05, 2040

    in 14 yr 2 mo

  50. Patent 12472156 expires

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

    Jun 05, 2040

    in 14 yr 2 mo

  51. Patent 12576078 expires

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

    Jun 05, 2040

    in 14 yr 2 mo

  52. Patent 12472174 expires

    Listed method-of-use patent (U-4515) expiration.

    Jan 20, 2043

    in 16 yr 10 mo

Pharmaceutical detail

Active ingredient

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Strength

105MG;30MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 215430

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

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

Marketing exclusivity (1)

  • I-913New indication exclusivity (3 years)

    Apr 30, 2029

    in 2 yr 11 mo

Listed patents (49)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8569328Jul 18, 2032in 6 yr 2 mo
ProductU-4516
10058518Nov 05, 2034in 8 yr 6 mo
U-4522
10080727Nov 05, 2034in 8 yr 6 mo
U-4520
10092560Nov 05, 2034in 8 yr 6 mo
U-4517
10105361Nov 05, 2034in 8 yr 6 mo
U-4522
10251879Nov 05, 2034in 8 yr 6 mo
U-4517
10780066Nov 05, 2034in 8 yr 6 mo
U-4517
11007189Nov 05, 2034in 8 yr 6 mo
U-4516
11207281Nov 05, 2034in 8 yr 6 mo
U-4537
11234946Nov 05, 2034in 8 yr 6 mo
U-4526
11253492Nov 05, 2034in 8 yr 6 mo
U-4526
11273133Nov 05, 2034in 8 yr 6 mo
U-4526
11273134Nov 05, 2034in 8 yr 6 mo
U-4517
11285118Nov 05, 2034in 8 yr 6 mo
U-4526
11285146Nov 05, 2034in 8 yr 6 mo
U-4517
11291638Nov 05, 2034in 8 yr 6 mo
U-4517
11291665Nov 05, 2034in 8 yr 6 mo
U-4517
11298352Nov 05, 2034in 8 yr 6 mo
U-4517
11344544Nov 05, 2034in 8 yr 6 mo
U-4517
11382874Nov 05, 2034in 8 yr 6 mo
U-4517
11419867Nov 05, 2034in 8 yr 6 mo
U-4517
11426370Nov 05, 2034in 8 yr 6 mo
U-4526
11571417Nov 05, 2034in 8 yr 6 mo
U-4526
11590124Nov 05, 2034in 8 yr 6 mo
U-4526
11617747Nov 05, 2034in 8 yr 6 mo
U-4526
9168234Nov 05, 2034in 8 yr 6 mo
U-4517
9198905Nov 05, 2034in 8 yr 6 mo
U-4520
9205083Nov 05, 2034in 8 yr 6 mo
U-4520
9238032Nov 05, 2034in 8 yr 6 mo
U-4520
9314462Nov 05, 2034in 8 yr 6 mo
U-4517
9370513Nov 05, 2034in 8 yr 6 mo
U-4520
9375429Nov 05, 2034in 8 yr 6 mo
U-4517
9408815Nov 05, 2034in 8 yr 6 mo
U-4517
9421176Nov 05, 2034in 8 yr 6 mo
U-4517
9457023Nov 05, 2034in 8 yr 6 mo
U-4517
9457025Nov 05, 2034in 8 yr 6 mo
U-4517
9474731Nov 05, 2034in 8 yr 6 mo
U-4520
9486450Nov 05, 2034in 8 yr 6 mo
U-4517
9700528Nov 05, 2034in 8 yr 6 mo
U-4517
9700553Nov 05, 2034in 8 yr 6 mo
U-4517
9707191Nov 05, 2034in 8 yr 6 mo
U-4522
9763932Nov 05, 2034in 8 yr 6 mo
U-4517
9861595Nov 05, 2034in 8 yr 6 mo
U-4517
9867819Nov 05, 2034in 8 yr 6 mo
U-4517
9968568Nov 05, 2034in 8 yr 6 mo
U-4517
12433884Jun 05, 2040in 14 yr 2 mo
U-4514
12472156Jun 05, 2040in 14 yr 2 mo
U-4516
12576078Jun 05, 2040in 14 yr 2 mo
U-4516
12472174Jan 20, 2043in 16 yr 10 mo
U-4515
Agent CTA Background

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

Book a Demo