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Product profile · United States

AUVELITY

 ·  Patent Litigation & Settlement History ↓

IngredientBUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Application typeNDA
Application215430
Product002
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
Strength105MG;30MG
Approval date2026-04-30
Marketing statusPrescription
Status event—
ApplicantAXSOME
Product source

Current GenericRadar decision

Year2032
SelectionDEEP_REVIEW
ReviewFINAL_CHECKING
Anchor typeDS_EQUIVALENT
Anchor date2032-07-18
Patent anchor2032-07-18
Exclusivity anchor2029-04-30
Protection date—
First Final ANDA—
Status event—

Confirmed combined anchor 2032-07-18; later listed patent protection remains.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
85693282032-07-18DP/U U-4516———
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100585182034-11-05U U-4522———
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100648572034-11-05U U-4517———
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100807272034-11-05U U-4520———
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100925602034-11-05U U-4517———
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100925612034-11-05U U-4517———
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101053612034-11-05U U-4522———
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102518792034-11-05U U-4517———
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104636342034-11-05U U-4517———
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105126432034-11-05U U-4517———
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107800662034-11-05U U-4517———
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108816242034-11-05U U-4517———
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110071892034-11-05U U-4516———
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112072812034-11-05U U-4537———
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112349462034-11-05U U-4526———
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112534922034-11-05U U-4526———
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112731332034-11-05U U-4526———
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112731342034-11-05U U-4517———
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112851182034-11-05U U-4526———
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112851462034-11-05U U-4517———
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112916382034-11-05U U-4517———
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112916652034-11-05U U-4517———
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112983522034-11-05U U-4517———
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113445442034-11-05U U-4517———
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113828742034-11-05U U-4517———
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114198672034-11-05U U-4517———
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114263702034-11-05U U-4526———
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115714172034-11-05U U-4526———
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115901242034-11-05U U-4526———
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116177472034-11-05U U-4526———
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91682342034-11-05U U-4517———
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91989052034-11-05U U-4520———
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92050832034-11-05U U-4520———
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92380322034-11-05U U-4520———
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92780952034-11-05U U-4517———
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93144622034-11-05U U-4517———
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93705132034-11-05U U-4520———
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93754292034-11-05U U-4517———
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94088152034-11-05U U-4517———
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94211762034-11-05U U-4517———
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94570232034-11-05U U-4517———
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94570252034-11-05U U-4517———
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94747312034-11-05U U-4520———
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94864502034-11-05U U-4517———
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97005282034-11-05U U-4517———
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97005532034-11-05U U-4517———
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97071912034-11-05U U-4522———
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97639322034-11-05U U-4517———
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98615952034-11-05U U-4517———
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98678192034-11-05U U-4517———
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99685682034-11-05U U-4517———
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124338842040-06-05U U-4514———
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124721562040-06-05U U-4516———
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125760782040-06-05U U-4516———
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124721742043-01-20U U-4515———
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126785062043-01-20DP ————
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Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
I-913—2029-04-30————Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / productApplicantEvent / status Certification event date Product mappingSourceLast verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

Event datePartyEvent Licensed entryEvidenceSource
2025-02-01 Teva SETTLEMENT
Brand-level record; strength scope not established
2038-09 REVIEW —
Pediatric-exclusivity contingency; 2039-03 potential alternative; verify