Product profile · United States
QUILLICHEW ER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8202537 | 2027-03-15 | DP — | N | N | FORMULATION | — | — | — |
| 8202537 | 2027-03-15 | DP — | N | N | FORMULATION Methylphenidate modified-release tablet with resin matrix and cured barrier coating. | — | — | — |
| 8287903 | 2031-02-15 | DP — | N | N | FORMULATION | — | — | — |
| 8287903 | 2031-02-15 | DP — | N | N | FORMULATION Methylphenidate resin-complex suspension, powder blend or solid dose with barrier coating, pH and release-profile limits. | — | — | — |
| 10857143 | 2033-08-14 | DP/U U-2993 | N | N | FORMULATION | — | — | — |
| 10857143 | 2033-08-14 | DP/U U-2993 | N | N | FORMULATION Methylphenidate resin-complex chewable tablet with coated sustained-release and immediate-release proportions. | — | — | — |
| 11103494 | 2033-08-14 | DP — | N | N | FORMULATION | — | — | — |
| 11103494 | 2033-08-14 | DP — | N | N | FORMULATION Extended-release methylphenidate resin-complex tablet with coated/IR components and PK restrictions. | — | — | — |
| 11103495 | 2033-08-14 | DP/U U-2993 | N | N | FORMULATION | — | — | — |
| 11103495 | 2033-08-14 | DP/U U-2993 | N | N | FORMULATION Divisible chewable methylphenidate tablet using specific resin, matrix, barrier coating and component ratios. | — | — | — |
| 11633389 | 2033-08-14 | DP — | N | N | FORMULATION | — | — | — |
| 11633389 | 2033-08-14 | DP — | N | N | FORMULATION Methylphenidate chewable resin-complex tablet with coating and sustained/immediate-release proportions. | — | — | — |
| 8999386 | 2033-08-14 | DP — | N | N | FORMULATION | — | — | — |
| 8999386 | 2033-08-14 | DP — | N | N | FORMULATION Methylphenidate chewable tablet with resin matrix, multiple release components and PK constraints. | — | — | — |
| 9295642 | 2033-08-14 | DP/U U-1827 | N | N | FORMULATION | — | — | — |
| 9295642 | 2033-08-14 | DP/U U-1827 | N | N | FORMULATION Methylphenidate chewable resin-complex tablet with multiple release components and PK restrictions. | — | — | — |
| 9545399 | 2033-08-14 | DP/U U-1827 | N | N | FORMULATION_USE | — | — | — |
| 9545399 | 2033-08-14 | DP/U U-1827 | N | N | FORMULATION_USE Methylphenidate ER chewable resin-complex tablet with coating, release proportions and PK limits; use claims depend on that tablet. | — | — | — |
| 9844544 | 2033-08-14 | DP/U U-2203 | N | N | FORMULATION_PK | — | — | — |
| 9844544 | 2033-08-14 | DP/U U-2203 | N | N | FORMULATION_PK Independent method and product claims require methylphenidate resin complexes, barrier coatings, release proportions and PK conditions. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2015-12-04 | 2018-12-04 | New methylphenidate extended-release chewable product for ADHD; all approved patient ages and strengths in this queue are covered by the product-level change. | Y | Y | 2018-12-04 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · 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 |
|---|---|---|---|---|---|---|---|
| 214202 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | TEVA PHARMS USA | 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 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 (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-03-15 | FTO_TAIL | Methylphenidate modified-release tablet with resin matrix and cured barrier coating. | Source |
| PATENT | 2031-02-15 | FTO_TAIL | Methylphenidate resin-complex suspension, powder blend or solid dose with barrier coating, pH and release-profile limits. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Extended-release methylphenidate resin-complex tablet with coated/IR components and PK restrictions. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Methylphenidate resin-complex chewable tablet with coated sustained-release and immediate-release proportions. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Methylphenidate chewable resin-complex tablet with coating and sustained/immediate-release proportions. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Independent method and product claims require methylphenidate resin complexes, barrier coatings, release proportions and PK conditions. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Methylphenidate ER chewable resin-complex tablet with coating, release proportions and PK limits; use claims depend on that tablet. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Divisible chewable methylphenidate tablet using specific resin, matrix, barrier coating and component ratios. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Methylphenidate chewable tablet with resin matrix, multiple release components and PK constraints. | Source |
| PATENT | 2033-08-14 | FTO_TAIL | Methylphenidate chewable resin-complex tablet with multiple release components and PK restrictions. | Source |
| REGULATORY_EXCLUSIVITY | 2018-12-04 | CANONICAL_ANCHOR | New methylphenidate extended-release chewable product for ADHD; all approved patient ages and strengths in this queue are covered by the product-level change. | Source |
| REGULATORY_STATUS | 2018-12-04 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.