Product profile · United States
ZUBSOLV
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
APPROVAL_YEAR_FALLBACK: no qualifying TrueDS/DS-equivalent patent or full-scope exclusivity anchor.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8658198 | 2027-12-03 | DP/U U-1494 | N | N | FORMULATION | — | — | — |
| 8658198 | 2027-12-03 | DP/U U-1494 | N | N | FORMULATION Opioid particles attached to larger antagonist carrier particles; method claims depend on that tablet architecture. | — | — | — |
| 8470361 | 2030-05-22 | DP/U U-1425 | N | N | FORMULATION | — | — | — |
| 8470361 | 2030-05-22 | DP/U U-1425 | N | N | FORMULATION Transmucosal tablet with opioid-analgesic particles on larger opioid-antagonist carrier particles and dose limitations. | — | — | — |
| 10946010 | 2032-09-18 | DP — | N | N | FORMULATION | — | — | — |
| 10946010 | 2032-09-18 | DP — | N | N | FORMULATION Buprenorphine microparticle and citric-acid/sodium-citrate contact tablet with 4:1 naloxone ratio. | — | — | — |
| 11020387 | 2032-09-18 | DP/U U-3131 | N | N | FORMULATION | — | — | — |
| 11020387 | 2032-09-18 | DP/U U-3131 | N | N | FORMULATION Buprenorphine/naloxone tablet with microparticles, acid, dose, weight and hardness constraints. | — | — | — |
| 11020388 | 2032-09-18 | DP/U U-3131 | N | N | FORMULATION | — | — | — |
| 11020388 | 2032-09-18 | DP/U U-3131 | N | N | FORMULATION Buprenorphine/naloxone microparticle tablet with acid and quantitative dissolution-test restriction. | — | — | — |
| 11433066 | 2032-09-18 | U U-3131 | N | N | FORMULATION_PROCESS_USE | — | — | — |
| 11433066 | 2032-09-18 | U U-3131 | N | N | FORMULATION_PROCESS_USE Opioid-dependence treatment requires acid-associated microparticle tablet manufactured by specified mixing/compression steps. | — | — | — |
| 8940330 | 2032-09-18 | DP — | N | N | FORMULATION | — | — | — |
| 8940330 | 2032-09-18 | DP — | N | N | FORMULATION Buprenorphine microparticles on carrier particles contacting separate citric-acid particles plus naloxone/disintegrant. | — | — | — |
| 9259421 | 2032-09-18 | DP — | N | N | FORMULATION | — | — | — |
| 9259421 | 2032-09-18 | DP — | N | N | FORMULATION Buprenorphine/naloxone acid-microparticle tablet with quantitative buffer-drip pH and excipient restrictions. | — | — | — |
| 9439900 | 2032-09-18 | DP — | N | N | FORMULATION | — | — | — |
| 9439900 | 2032-09-18 | DP — | N | N | FORMULATION Buprenorphine/naloxone sublingual tablet requiring separate acid particles and microparticles plus specified dose/ratio. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-713 | 2015-08-10 | 2018-08-10 | REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ('INDUCTION') TREATMENT OF OPIOID DEPENDENCE | N | N | — | 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 |
|---|---|---|---|---|---|---|---|
| 214737 / 005 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SUN PHARM INDUSTRIES | 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 (11)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-12-03 | FTO_TAIL | Opioid particles attached to larger antagonist carrier particles; method claims depend on that tablet architecture. | Source |
| PATENT | 2030-05-22 | FTO_TAIL | Transmucosal tablet with opioid-analgesic particles on larger opioid-antagonist carrier particles and dose limitations. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Opioid-dependence treatment requires acid-associated microparticle tablet manufactured by specified mixing/compression steps. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine/naloxone tablet with microparticles, acid, dose, weight and hardness constraints. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine/naloxone sublingual tablet requiring separate acid particles and microparticles plus specified dose/ratio. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine microparticle and citric-acid/sodium-citrate contact tablet with 4:1 naloxone ratio. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine/naloxone microparticle tablet with acid and quantitative dissolution-test restriction. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine/naloxone acid-microparticle tablet with quantitative buffer-drip pH and excipient restrictions. | Source |
| PATENT | 2032-09-18 | FTO_TAIL | Buprenorphine microparticles on carrier particles contacting separate citric-acid particles plus naloxone/disintegrant. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ('INDUCTION') TREATMENT OF OPIOID DEPENDENCE | Source |
| REGULATORY_STATUS | 2015-06-04 | DECISION_BASIS | APPROVAL_YEAR_FALLBACK: no qualifying TrueDS/DS-equivalent patent or full-scope exclusivity anchor. | 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.