Product profile · United States

ALTABAX

· Patent Litigation & Settlement History ↓

IngredientRETAPAMULIN

Application typeNDA

Application022055

Product001

Dosage formOINTMENT

RouteTOPICAL

Strength1%

Approval date2007-04-12

Marketing statusDiscontinued

Status event—

ApplicantALMIRALL LLC

Approved indications

Topical treatment of impetigo due to susceptible methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes in adults and children aged 9 months and older.

Product source

Current GenericRadar decision

Year2024

SelectionDISCONTINUED

ReviewFINAL

Anchor typePATENT

Anchor date2021-04-12

Patent anchor2021-04-12

Exclusivity anchor2012-04-12

Protection date2021-04-12

First Final ANDA—

Status event—

2024 DISCONTINUED: FDA May 2024 cumulative Orange Book supplement records N022055/001 as May DISC; current FDA listing remains Discontinued. This is FDA status-change month, not an exact last-sale date or NDA withdrawal date. status_event_date=NULL, status_event_month=2024-05. Patent anchor RE43390 2021-04-12; NCE 2012-04-12; later restricted claims extend to 2027-02-14. US7875630 DS-equivalent remains unestablished and is not promoted. Current OB has zero retapamulin ANDA rows; historical Final ANDA absence is not established.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
RE43390	2021-04-12	DS/DP/U U-805	Y	N	TRUE_DS RE43390 date per historical FDA OB. 8207191 date 2024-08-30 from patent term metadata; official historical OB date not independently reverified in this batch. 7875630 date per current FDA OB. No unverified extension added.	—	—	—
8207191	2024-08-30	U U-805	N	N	U RE43390 date per historical FDA OB. 8207191 date 2024-08-30 from patent term metadata; official historical OB date not independently reverified in this batch. 7875630 date per current FDA OB. No unverified extension added.	—	—	—
7875630	2027-02-14	DS —	N	N	CRYSTAL_FORM RE43390 date per historical FDA OB. 8207191 date 2024-08-30 from patent term metadata; official historical OB date not independently reverified in this batch. 7875630 date per current FDA OB. No unverified extension added.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2007-04-12	2012-04-12	Five-year NCE for original ALTABAX approval; whole exact product and original indication.	Y	Y	2012-04-12	—	Source

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
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.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last 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 / product	Applicant	Event / status	First marketed	Product mapping	Source	Last 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 / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last 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 / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last 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 / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (6)

Type	Date	Role	Basis	Source
EXCLUSIVITY	2012-04-12	EXCLUSIVITY_ANCHOR	NCE full-product end earlier than patent anchor.	Source
GENERIC	—	GENERIC_CHECK	Current FDA OB products.txt retapamulin: one NDA row, zero ANDA rows. Exhaustive historical Final ANDA absence not established.	Source
PATENT	2021-04-12	PATENT_ANCHOR	TRUE_DS: claim 25 expressly claims retapamulin itself without a solid-form or formulation limitation. Reissue of RE39128, itself reissue of US6281226. FDA historical OB lists 2021-04-12; no additional unverified PED added.	Source
PATENT	2024-08-30	PATENT_TAIL	Use claims limited to specified crystalline retapamulin or hydrosuccinate salt. Not adopted as DS-equivalent; no unrestricted whole-product claim.	Source
PATENT	2027-02-14	PATENT_TAIL	Process, specific crystal/salt and crystal-containing composition claims. TRUE_DS=N. DS-equivalent not established: FDA melting range alone does not conclusively map DSC onset/XRPD/IR claim conditions or establish mandatory generic use. Preserve for follow-up.	Source
REGULATORY	—	STATUS_EVENT	FDA May 2024 cumulative OB, PDF page 90, RX list page 1-79: N022055/001 May DISC. Month precision only; exact date NULL. Current FDA Discontinued supports continuing status.	Source

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.

No litigation or settlement record currently linked to this product.