Product profile · United States
MORPHABOND ER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA approval of this entire NDA and its strengths was withdrawn effective 2021-01-22. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10314788 | 2028-08-12 | DP — | N | N | ABUSE_DETERRENT_DOSAGE_FORM | — | — | — |
| 10314788 | 2028-08-12 | DP — | N | N | ABUSE_DETERRENT_DOSAGE_FORM Independent claims require monolithic expansion, barrier, and diffusion layers with opioid release or pharmacokinetic behavior after division. July 30, 2019 certificate corrections were checked. | — | — | — |
| 7955619 | 2028-08-12 | DP — | N | N | LAYERED_DOSAGE_FORM | — | — | — |
| 7955619 | 2028-08-12 | DP — | N | N | LAYERED_DOSAGE_FORM Independent claims require bonded barrier and drug diffusion layers; additional claims restrict expansion layers and release properties. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 074862 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1998-07-07 | — | RHODES PHARMACEUTICALS LP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 075295 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1998-10-28 | — | STRIDES PHARMA INTERNATIONAL AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 075407 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2000-01-28 | — | DAVA PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076412 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2003-07-31 | — | SPECGX LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076733 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2004-05-19 | — | NESHER PHARMACEUTICALS USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 200824 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-10-18 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078761 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-05-11 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203849 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-06 | — | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203602 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-16 | — | NOVEL LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091357 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-23 | — | EPIC PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205634 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-25 | — | SUN PHARMACEUTICAL INDUSTRIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205386 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-10-28 | — | DR REDDYS LABORATORIES SA | 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 12 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 |
|---|---|---|---|---|---|---|
| 074862 / 001 | RHODES PHARMACEUTICALS LP | FINAL_APPROVAL · FINAL_APPROVED | 1998-07-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 075295 / 001 | STRIDES PHARMA INTERNATIONAL AG | FINAL_APPROVAL · FINAL_APPROVED | 1998-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 075407 / 001 | DAVA PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2000-01-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076412 / 001 | SPECGX LLC | FINAL_APPROVAL · FINAL_APPROVED | 2003-07-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076733 / 001 | NESHER PHARMACEUTICALS USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2004-05-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 200824 / 001 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-10-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 078761 / 001 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2012-05-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203849 / 001 | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203602 / 001 | NOVEL LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091357 / 001 | EPIC PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205634 / 001 | SUN PHARMACEUTICAL INDUSTRIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205386 / 001 | DR REDDYS LABORATORIES SA | FINAL_APPROVAL · FINAL_APPROVED | 2016-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-08-12 | FTO_TAIL | Independent claims require bonded barrier and drug diffusion layers; additional claims restrict expansion layers and release properties. | Source |
| PATENT | 2028-08-12 | FTO_TAIL | Independent claims require monolithic expansion, barrier, and diffusion layers with opioid release or pharmacokinetic behavior after division. July 30, 2019 certificate corrections were checked. | Source |
| REGULATORY_STATUS | 2021-01-22 | TERMINAL_STATUS | FDA approval of this entire NDA and its strengths was withdrawn effective 2021-01-22. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date. | 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.