Product profile · United States
IBRANCE
· 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 |
|---|---|---|---|---|---|---|---|---|
| RE47739 | 2027-03-05 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| RE47739 | 2027-03-05 | DS/DP — | Y | Y | TRUE_DS Current independent claim 11 explicitly claims palbociclib or acceptable salts; current claim 2 and corrected claim 7 also provide compound scope. Deleted bracketed claim 1 was excluded. PTE included in listed expiry. | — | — | — |
| RE47739 | 2027-09-05 | — — | Y | Y | TRUE_DS | — | 2027-09-05 | — |
| RE47739 | 2027-09-05 | PED — | Y | Y | TRUE_DS Current independent claim 11 explicitly claims palbociclib or acceptable salts; current claim 2 and corrected claim 7 also provide compound scope. Deleted bracketed claim 1 was excluded. PTE included in listed expiry. | — | — | — |
| 10723730 | 2034-02-08 | DS/DP — | N | N | CRYSTAL_PARTICLE_SIZE | — | — | — |
| 10723730 | 2034-02-08 | DS/DP — | N | N | CRYSTAL_PARTICLE_SIZE Independent claims 1, 7 and 15 restrict palbociclib crystal XRPD and D90 or D[4,3] particle size; official DS flag does not establish TrueDS. | — | — | — |
| 10723730 | 2034-08-08 | — — | N | N | CRYSTAL_PARTICLE_SIZE | — | 2034-08-08 | — |
| 10723730 | 2034-08-08 | PED — | N | N | CRYSTAL_PARTICLE_SIZE Independent claims 1, 7 and 15 restrict palbociclib crystal XRPD and D90 or D[4,3] particle size; official DS flag does not establish TrueDS. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-725 | 2016-02-19 | 2019-02-19 | TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY. | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| NCE | 2015-02-03 | 2020-02-03 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2020-02-03 | I-725 + M-14 + I-995
Full coverage date: 2020-02-03
| Source |
| M-14 | 2025-09-16 | 2028-09-16 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| M-14 | 2025-09-16 | 2028-09-16 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| PED | 2028-09-16 | 2029-03-16 | Six-month extension of M-14: ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| PED | 2028-09-16 | 2029-03-16 | Six-month extension of M-14: ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| I-995 | 2026-06-24 | 2029-06-24 | IN COMBINATION WITH TRASTUZUMAB, WITH OR WITHOUT PERTUZUMAB, AND ENDOCRINETHERAPY FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING INDUCTION TREATMENT | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
| I-995 | 2026-06-24 | 2029-06-24 | IN COMBINATION WITH TRASTUZUMAB, WITH OR WITHOUT PERTUZUMAB, AND ENDOCRINETHERAPY FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING INDUCTION TREATMENT | N | N | — | I-725 + M-14 + I-995
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 213086 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | EUGIA PHARMA SPECLTS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213091 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | DR REDDYS LABS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213107 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SUN PHARM INDS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213152 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214758 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | MSN 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 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 (10)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-03-05 | LISTING_CONTEXT | Current independent claim 11 explicitly claims palbociclib or acceptable salts; current claim 2 and corrected claim 7 also provide compound scope. Deleted bracketed claim 1 was excluded. PTE included in listed expiry. | Source |
| PATENT | 2027-09-05 | CANONICAL_ANCHOR | Current independent claim 11 explicitly claims palbociclib or acceptable salts; current claim 2 and corrected claim 7 also provide compound scope. Deleted bracketed claim 1 was excluded. PTE included in listed expiry. | Source |
| PATENT | 2034-02-08 | FTO_TAIL | Independent claims 1, 7 and 15 restrict palbociclib crystal XRPD and D90 or D[4,3] particle size; official DS flag does not establish TrueDS. | Source |
| PATENT | 2034-08-08 | FTO_TAIL | Independent claims 1, 7 and 15 restrict palbociclib crystal XRPD and D90 or D[4,3] particle size; official DS flag does not establish TrueDS. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension of M-14: ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | IN COMBINATION WITH TRASTUZUMAB, WITH OR WITHOUT PERTUZUMAB, AND ENDOCRINETHERAPY FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING INDUCTION TREATMENT | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | Source |
| REGULATORY_EXCLUSIVITY | 2020-02-03 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2027-09-05 | 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.