Product profile · United States
KATERZIA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rereview correction: FDA first-generic and CGT lists explicitly identify ANDA 215035 referencing KATERZIA NDA 211340, 1 mg/mL, Final approval 2023-06-13. A linked earlier tentative-approval document does not negate the subsequent Final approval. EXISTING_GENERIC 2023.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10894039 | 2037-10-06 | U U-185 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10894039 | 2037-10-06 | U U-3 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10894039 | 2037-10-06 | U U-185 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS HTN only: amlodipine benzoate 1 mg/mL, citrate/Na benzoate/SiO2/HPMC/simethicone/polysorbate, pH, and stability. | — | — | — |
| 10894039 | 2037-10-06 | U U-3 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS HTN only: amlodipine benzoate 1 mg/mL, citrate/Na benzoate/SiO2/HPMC/simethicone/polysorbate, pH, and stability. | — | — | — |
| 10952998 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10952998 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Amlodipine benzoate/naphthalene sulfonate liquid with buffer, preservative, suspension aid, antifoam, surfactant, and stability limitations. | — | — | — |
| 10959991 | 2037-10-06 | U U-39 | N | N | INDICATION_FORMULATION_USE | — | — | — |
| 10959991 | 2037-10-06 | U U-158 | N | N | INDICATION_FORMULATION_USE | — | — | — |
| 10959991 | 2037-10-06 | U U-39 | N | N | INDICATION_FORMULATION_USE Claim 1: CAD and specific amlodipine-suspension composition/stability. Hypertension excluded; all-indication coverage N. | — | — | — |
| 10959991 | 2037-10-06 | U U-158 | N | N | INDICATION_FORMULATION_USE Claim 1: CAD and specific amlodipine-suspension composition/stability. Hypertension excluded; all-indication coverage N. | — | — | — |
| 11364230 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11364230 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Liquid amlodipine fixed formulation, consisting essentially of specified ingredients, with pH/stability limitations. | — | — | — |
| 11471409 | 2037-10-06 | U U-3448 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11471409 | 2037-10-06 | U U-3447 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11471409 | 2037-10-06 | U U-3448 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Independent claim 1 covers HTN and claim 19 CAD; product-by-process limitations require D50 5-40 um and 20-100 kHz ultrasonication. | — | — | — |
| 11471409 | 2037-10-06 | U U-3447 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Independent claim 1 covers HTN and claim 19 CAD; product-by-process limitations require D50 5-40 um and 20-100 kHz ultrasonication. | — | — | — |
| 11484498 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11484498 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS D50 5–40um·besylate+sodium benzoate1min–1h mixing product-by-process | — | — | — |
| 11701326 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11701326 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Product-by-process limitations: D50 5-40 um and specified mixing for one minute to one hour. | — | — | — |
| 11918685 | 2037-10-06 | U U-3447 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11918685 | 2037-10-06 | U U-3448 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 11918685 | 2037-10-06 | U U-3448 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Independent claim 1 covers HTN and claim 16 CAD; product-by-process limitations require D50 and specified mixing. | — | — | — |
| 11918685 | 2037-10-06 | U U-3447 | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Independent claim 1 covers HTN and claim 16 CAD; product-by-process limitations require D50 and specified mixing. | — | — | — |
| 12053461 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 12053461 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Benzoate/naphthalene sulfonate liquid with fixed excipient/stability limitations. | — | — | — |
| 12336984 | 2037-10-06 | U U-3448 | N | N | INDICATION_FORMULATION_USE | — | — | — |
| 12336984 | 2037-10-06 | U U-3447 | N | N | INDICATION_FORMULATION_USE | — | — | — |
| 12336984 | 2037-10-06 | U U-3447 | N | N | INDICATION_FORMULATION_USE Claim 1: CAD with amlodipine benzoate 1 mg/mL, Na benzoate, suspension aid, surfactant, and stability limitations. Hypertension excluded. | — | — | — |
| 12336984 | 2037-10-06 | U U-3448 | N | N | INDICATION_FORMULATION_USE Claim 1: CAD with amlodipine benzoate 1 mg/mL, Na benzoate, suspension aid, surfactant, and stability limitations. Hypertension excluded. | — | — | — |
| 12383498 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 12383498 | 2037-10-06 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Product-by-process limitations: D10 1-10 um and specified mixing. | — | — | — |
| 12721843 | 2037-10-06 | DP — | N | N | FIXED_LIQUID_FORMULATION | — | — | — |
| 12721843 | 2037-10-06 | DP — | N | N | FIXED_LIQUID_FORMULATION Independent claim 1: amlodipine benzoate 1 mg/mL free-base equivalent, sodium benzoate 0.2-10 mg/mL, specified suspension aid, nonionic surfactant 0.1-3 mg/mL, water, and >=12-month stability at 5 +/-5 C with >=95% potency and <=5% impurities. Claims 2-20 are dependent. Not formulation-unrestricted substance protection; essential correspondence across all products is unproven: DS-equivalent N. | — | — | — |
| 10695329 | 2037-10-16 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10695329 | 2037-10-16 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Benzoate 1 mg/mL, citrate 3 mM, SiO2/HPMC/simethicone/polysorbate 80, pH 4-6, and stability. | — | — | — |
| 10799453 | 2039-04-11 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10799453 | 2039-04-11 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS D50 5–40um·ultrasonic product-by-process | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-10 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 215035 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-13 | — | AMNEAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 215035 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-13 | — | AMNEAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 215035 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2023-06-13 | — | AMNEAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 215035 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2023-06-13 | — | AMNEAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
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 4 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 |
|---|---|---|---|---|---|---|
| 215035 / 001 | AMNEAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-13 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 215035 / 001 | AMNEAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-13 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 215035 / 001 | AMNEAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVAL | 2023-06-13 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 215035 / 001 | AMNEAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVAL | 2023-06-13 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2023-06-13 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA215035/001 -> NDA211340/001 | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Product-by-process limitations: D50 5-40 um and specified mixing for one minute to one hour. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | HTN only: amlodipine benzoate 1 mg/mL, citrate/Na benzoate/SiO2/HPMC/simethicone/polysorbate, pH, and stability. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Independent claim 1: amlodipine benzoate 1 mg/mL free-base equivalent, sodium benzoate 0.2-10 mg/mL, specified suspension aid, nonionic surfactant 0.1-3 mg/mL, water, and >=12-month stability at 5 +/-5 C with >=95% potency and <=5% impurities. Claims 2-20 are dependent. Not formulation-unrestricted substance protection; essential correspondence across all products is unproven: DS-equivalent N. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Independent claim 1 covers HTN and claim 16 CAD; product-by-process limitations require D50 and specified mixing. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Claim 1: CAD with amlodipine benzoate 1 mg/mL, Na benzoate, suspension aid, surfactant, and stability limitations. Hypertension excluded. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Claim 1: CAD and specific amlodipine-suspension composition/stability. Hypertension excluded; all-indication coverage N. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | HTN only: amlodipine benzoate 1 mg/mL, citrate/Na benzoate/SiO2/HPMC/simethicone/polysorbate, pH, and stability. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Liquid amlodipine fixed formulation, consisting essentially of specified ingredients, with pH/stability limitations. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Independent claim 1 covers HTN and claim 19 CAD; product-by-process limitations require D50 5-40 um and 20-100 kHz ultrasonication. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Benzoate/naphthalene sulfonate liquid with fixed excipient/stability limitations. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Amlodipine benzoate/naphthalene sulfonate liquid with buffer, preservative, suspension aid, antifoam, surfactant, and stability limitations. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Independent claim 1 covers HTN and claim 16 CAD; product-by-process limitations require D50 and specified mixing. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Claim 1: CAD with amlodipine benzoate 1 mg/mL, Na benzoate, suspension aid, surfactant, and stability limitations. Hypertension excluded. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Claim 1: CAD and specific amlodipine-suspension composition/stability. Hypertension excluded; all-indication coverage N. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | D50 5–40um·besylate+sodium benzoate1min–1h mixing product-by-process | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Product-by-process limitations: D10 1-10 um and specified mixing. | Source |
| PATENT | 2037-10-06 | FTO_TAIL | Independent claim 1 covers HTN and claim 19 CAD; product-by-process limitations require D50 5-40 um and 20-100 kHz ultrasonication. | Source |
| PATENT | 2037-10-16 | FTO_TAIL | Benzoate 1 mg/mL, citrate 3 mM, SiO2/HPMC/simethicone/polysorbate 80, pH 4-6, and stability. | Source |
| PATENT | 2039-04-11 | FTO_TAIL | D50 5–40um·ultrasonic product-by-process | 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.