Product profile · United States
RELEXXII
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. FDA Final approval letter for ANDA 205327 identifies CONCERTA as the reference, including the 72 mg suitability-petition strength. Its former RELEXXII brand name does not make it a direct-reference generic of NDA 216117. Other available candidates are in the CONCERTA reference family or lack direct-reference proof.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10265308 | 2037-02-03 | DP/U U-4032 | N | N | ETHANOL_RESISTANT_METHYLPHENIDATE_FORMULATION | — | — | — |
| 10265308 | 2037-02-03 | DP/U U-4032 | N | N | ETHANOL_RESISTANT_METHYLPHENIDATE_FORMULATION Claim 1 requires an extended-release composition satisfying specific ethanol-related and timed dissolution thresholds. It does not claim methylphenidate itself. | — | — | — |
| 10695336 | 2037-02-03 | U U-4032 | N | N | METHYLPHENIDATE_RELEASE_AND_PK_TREATMENT | — | — | — |
| 10695336 | 2037-02-03 | U U-4032 | N | N | METHYLPHENIDATE_RELEASE_AND_PK_TREATMENT Independent treatment claims require immediate plus extended-release methylphenidate, ethanol-resistance thresholds and defined release/PK profiles; some claims specify 54 mg or 72 mg. | — | — | — |
| 9707217 | 2037-02-03 | DP — | N | N | OSMOTIC_METHYLPHENIDATE_RELEASE | — | — | — |
| 9707217 | 2037-02-03 | DP — | N | N | OSMOTIC_METHYLPHENIDATE_RELEASE Claim 1 requires an osmotic core enclosed by a semipermeable membrane and a specified release profile in an ethanol/hydrochloric-acid test. | — | — | — |
| 9827234 | 2037-02-03 | U U-4032 | N | N | OSMOTIC_METHYLPHENIDATE_TREATMENT | — | — | — |
| 9827234 | 2037-02-03 | U U-4032 | N | N | OSMOTIC_METHYLPHENIDATE_TREATMENT Claim 1 requires treatment using an osmotic core/membrane device with a specified ethanol dissolution profile. The broad condition language does not remove the dosage-form limitations. | — | — | — |
| 9855258 | 2037-02-03 | DP/U U-4032 | N | N | OSMOTIC_METHYLPHENIDATE_COATING | — | — | — |
| 9855258 | 2037-02-03 | DP/U U-4032 | N | N | OSMOTIC_METHYLPHENIDATE_COATING Independent claims require an osmotic core, semipermeable membrane, an immediate/rapid-release outer coating and defined ethanol resistance and release behavior. | — | — | — |
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. | ||||||||
2026-10-11 · 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 |
|---|---|---|---|---|---|---|---|
| 216117 / 005 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Osmotica Pharmaceutical US LLC | Y | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076655 / 004 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076772 / 004 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202608 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2012-12-28 | — | SPECGX LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091695 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2013-09-23 | — | LANNETT CO INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206726 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2016-10-21 | — | AUROLIFE PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208607 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-14 | — | ANI PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205327 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-28 | — | OSMOTICA PHARMACEUTICAL US LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207515 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2018-02-01 | — | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076655 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-03-21 | — | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210818 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-30 | — | ALVOGEN INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211918 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-24 | — | ANDOR PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204659 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-07-15 | — | STRIDES PHARMA INTERNATIONAL AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211009 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-03 | — | ASCENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213473 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-29 | — | GRANULES PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205135 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-19 | — | SUN PHARMACEUTICAL INDUSTRIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214111 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2022-05-31 | — | RHODES PHARMACEUTICALS LP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214447 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-23 | — | ALKEM LABORATORIES LTD | 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 1 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 216117 / 005 | Osmotica Pharmaceutical US LLC | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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 15 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 |
|---|---|---|---|---|---|---|
| 202608 / 003 | SPECGX LLC | FINAL_APPROVAL · FINAL_APPROVED | 2012-12-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091695 / 004 | LANNETT CO INC | FINAL_APPROVAL · FINAL_APPROVED | 2013-09-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206726 / 004 | AUROLIFE PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-10-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208607 / 004 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205327 / 004 | OSMOTICA PHARMACEUTICAL US LLC | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207515 / 004 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | FINAL_APPROVAL · FINAL_APPROVED | 2018-02-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076655 / 001 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-03-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210818 / 004 | ALVOGEN INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211918 / 004 | ANDOR PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204659 / 002 | STRIDES PHARMA INTERNATIONAL AG | FINAL_APPROVAL · FINAL_APPROVED | 2019-07-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211009 / 004 | ASCENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213473 / 004 | GRANULES PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205135 / 004 | SUN PHARMACEUTICAL INDUSTRIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214111 / 004 | RHODES PHARMACEUTICALS LP | FINAL_APPROVAL · FINAL_APPROVED | 2022-05-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214447 / 004 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (6)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-02-03 | FTO_TAIL | Claim 1 requires an extended-release composition satisfying specific ethanol-related and timed dissolution thresholds. It does not claim methylphenidate itself. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Independent claims require an osmotic core, semipermeable membrane, an immediate/rapid-release outer coating and defined ethanol resistance and release behavior. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Claim 1 requires treatment using an osmotic core/membrane device with a specified ethanol dissolution profile. The broad condition language does not remove the dosage-form limitations. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Claim 1 requires an osmotic core enclosed by a semipermeable membrane and a specified release profile in an ethanol/hydrochloric-acid test. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Independent treatment claims require immediate plus extended-release methylphenidate, ethanol-resistance thresholds and defined release/PK profiles; some claims specify 54 mg or 72 mg. | Source |
| REGULATORY_STATUS | 2022-06-23 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. FDA Final approval letter for ANDA 205327 identifies CONCERTA as the reference, including the 72 mg suitability-petition strength. Its former RELEXXII brand name does not make it a direct-reference generic of NDA 216117. Other available candidates are in the CONCERTA reference family or lack direct-reference proof. | 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.