Product profile · United States
JORNAY PM
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Historical FDA NP 2018-08-08 to 2021-08-08 is the whole-product anchor. Conditional PK/formulation claims are not promoted without all required PK evidence. Other methylphenidate release formulations are not direct JORNAY PM generics.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10182995 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 10182995 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK MPH SR polymer/water-soluble polymer/hydrophobic plasticizer/binder plus pH coat and eight-hour in-vitro lag. | — | — | — |
| 10292937 | 2032-03-23 | U U-2357 | N | N | FORMULATION_RESTRICTED_USE | — | — | — |
| 10292937 | 2032-03-23 | U U-2357 | N | N | FORMULATION_RESTRICTED_USE Claim 1: SR polymer ratio/DBS/Mg stearate/pH coating/administration-time limitations. Necessity for every product is unproven; N proposed. | — | — | — |
| 10617651 | 2032-03-23 | U U-2357 | N | N | DISSOLUTION_RESTRICTED_USE | — | — | — |
| 10617651 | 2032-03-23 | U U-2357 | N | N | DISSOLUTION_RESTRICTED_USE Independent claim 1: age-unrestricted treatment of MPH-responsive disorders requiring SR-layer polymer/plasticizer/binder, pH-dependent coat, and specified USP testing with eight-hour lag <=10% and release at 10-12 hours. Full-label correspondence is not established; DS-equivalent default N. | — | — | — |
| 10881618 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_FORMULATION_RESTRICTED_USE | — | — | — |
| 10881618 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_FORMULATION_RESTRICTED_USE Independent claim 1 is limited to pediatric/adolescent ADHD: MPH core (HPMC/MCC), SR (DBS/EC/HPC/Mg stearate), DR (DBS/methacrylic acid Type B/mono-diglycerides/polysorbate 80), six-hour lag <=5%, and Tmax 12-16 hours. Claims 2-7 are dependent. Adult indication excluded; DS-equivalent N. | — | — | — |
| 10905652 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 10905652 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK MPH with 11 fixed core/SR/DR excipients, six-hour lag <=5%, and Tmax 12-16 hours. | — | — | — |
| 11241391 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_RESTRICTED_USE | — | — | — |
| 11241391 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_RESTRICTED_USE Independent claims 1/8: pediatric/adolescent ADHD with specified coated-particle excipients, six-hour lag, and Tmax. Adults excluded; N/N. | — | — | — |
| 11241392 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 11241392 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK MPH coated particles with fixed excipients, six-hour lag <=5%, and Tmax 12-16 hours. | — | — | — |
| 11911518 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_RESTRICTED_USE | — | — | — |
| 11911518 | 2032-03-23 | U U-2357 | N | N | PEDIATRIC_RESTRICTED_USE Claim 1: pediatric/adolescent ADHD only; adults excluded, so full-label coverage N. | — | — | — |
| 8916588 | 2032-03-23 | U U-2357 | N | Y | DS_EQUIVALENT | — | — | — |
| 8916588 | 2032-03-23 | U U-2357 | N | Y | DS_EQUIVALENT Claims 1/17: age-unrestricted ADHD, SR/DR layers, and lag/AUC/Tmax. DS-equivalent Y proposed and adopted based on correspondence with the 2026 FDA label: ADHD aged six and older, dose proportionality 20-100 mg, <=5% absorbed during the first ten hours, and Tmax 14 hours. Label total-drug availability differs from AUC0-10/AUC0-48 and Cmax lag; satisfaction of every condition remains unconfirmed. ADOPTED_CLASSIFICATION. | — | — | — |
| 8927010 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 8927010 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK CNS stimulant SR/DR or capsule unit dose with PK lag >=5 hours, AUC0-10 <7%, and Tmax 12-19 hours. | — | — | — |
| 9023389 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 9023389 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK CNS stimulant SR/DR polymer/pH coat with eight-hour in-vitro lag. | — | — | — |
| 9028868 | 2032-03-23 | U U-2357 | N | Y | DS_EQUIVALENT | — | — | — |
| 9028868 | 2032-03-23 | U U-2357 | N | Y | DS_EQUIVALENT Independent claim 1: amphetamine; independent claim 6: CNS stimulant SR/DR, lag/AUC/Tmax, and age-unrestricted ADHD. MPH applicability and essential PK correspondence are provisional. | — | — | — |
| 9034902 | 2032-03-23 | U U-2357 | N | N | RELEASE_RESTRICTED_USE | — | — | — |
| 9034902 | 2032-03-23 | U U-2357 | N | N | RELEASE_RESTRICTED_USE Claim 1: core/SR/DR, eight-hour in-vitro lag, and sustained release at 10-12 hours. Necessity for every product is unproven; N proposed. | — | — | — |
| 9283214 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 9283214 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK Single-population beads with fasted lag >=7 hours, AUC/Tmax, and efficacy >=12 hours. | — | — | — |
| 9498447 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 9498447 | 2032-03-23 | DP — | N | N | FORMULATION_OR_PK SR/DR polymer/pH coat with eight-hour in-vitro lag. | — | — | — |
| 9603809 | 2032-03-23 | U U-2357 | N | N | PK_EFFICACY_RESTRICTED_USE | — | — | — |
| 9603809 | 2032-03-23 | U U-2357 | N | N | PK_EFFICACY_RESTRICTED_USE Claim 1: fasted lag/AUC/Tmax and significant ADHD improvement for >=12 hours. Necessity across the entire approved scope is unproven; N proposed. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 078458 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-12-01 | — | DR REDDYS LABORATORIES SA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079031 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-07-13 | — | BARR LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077707 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2012-07-19 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203583 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-29 | — | SPECGX LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205105 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2016-07-28 | — | IMPAX LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208861 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-13 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211796 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-23 | — | GRANULES PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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 7 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 |
|---|---|---|---|---|---|---|
| 078458 / 001 | DR REDDYS LABORATORIES SA | FINAL_APPROVAL · FINAL_APPROVED | 2011-12-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 079031 / 001 | BARR LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2012-07-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077707 / 002 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2012-07-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203583 / 002 | SPECGX LLC | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205105 / 002 | IMPAX LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-07-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208861 / 003 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211796 / 002 | GRANULES PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| FINAL_REVIEW | — | ANCHOR_AND_TAIL | Historical FDA NP 2018-08-08 to 2021-08-08 is the whole-product anchor. Conditional PK/formulation claims are not promoted without all required PK evidence. Other methylphenidate release formulations are not direct JORNAY PM generics. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2021 | DEEP_REVIEW | FINAL | 2021-08-08 | 2026-10-17 06:56:57 |
| N | 2032 | CANDIDATE | FINAL | 2032-03-23 | 2026-10-11 08:22:00 |
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.