ACIPHEX SPRINKLE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2016 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5045552 | 2013-11-08 | PED — | Y | N | TRUE_DS Independent claim1 protects the rabeprazole chemical structure and pharmaceutically acceptable salts; claim2 specifies the sodium salt. No mandatory formulation or crystal limitation. | — | 2013-11-08 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2013-03-26 | 2016-03-26 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NDF covers the exact 5 mg and 10 mg sprinkle capsules for GERD in children 1 through 11 years; PED extends that NDF from 2016-03-26 to 2016-09-26. Do not borrow adult tablet indications. | Y | Y | 2016-03-26 | Source | |
| PED | 2016-03-27 | 2016-09-26 | ATTACHED_EXTENSION; NDF covers the exact 5 mg and 10 mg sprinkle capsules for GERD in children 1 through 11 years; PED extends that NDF from 2016-03-26 to 2016-09-26. Do not borrow adult tablet indications. | Y | Y | 2016-09-26 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2013-11-08 | CANONICAL_ANCHOR | Independent claim1 protects the rabeprazole chemical structure and pharmaceutically acceptable salts; claim2 specifies the sodium salt. No mandatory formulation or crystal limitation. | Source |
| REGULATORY_EXCLUSIVITY | 2016-03-26 | SCOPE_CONTEXT | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NDF covers the exact 5 mg and 10 mg sprinkle capsules for GERD in children 1 through 11 years; PED extends that NDF from 2016-03-26 to 2016-09-26. Do not borrow adult tablet indications. | Source |
| REGULATORY_EXCLUSIVITY | 2016-09-26 | SCOPE_CONTEXT | ATTACHED_EXTENSION; NDF covers the exact 5 mg and 10 mg sprinkle capsules for GERD in children 1 through 11 years; PED extends that NDF from 2016-03-26 to 2016-09-26. Do not borrow adult tablet indications. | Source |
| REGULATORY_STATUS | 2021-12-01 | TERMINAL_STATUS | FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2016 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication. | Source |
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.