Product profile · United States
PREVYMIS
· 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 |
|---|---|---|---|---|---|---|---|---|
| RE46791 | 2029-01-18 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| RE46791 | 2029-01-18 | DS/DP — | Y | Y | TRUE_DS Independent claim 1 chemical genus includes letermovir; claims 26-28 identify letermovir species and salts. Structures visually checked. USPTO PTE correction retained; no extra extension added to Orange Book date. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2017-11-08 | 2022-11-08 | 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 | 2022-11-08 | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: 2022-11-08
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: 2022-11-08
| Source |
| ODE-165 | 2017-11-08 | 2024-11-08 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| I-916 | 2023-06-05 | 2026-06-05 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| I-916 | 2023-06-05 | 2026-06-05 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| D-189 | 2023-08-02 | 2026-08-02 | EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| D-189 | 2023-08-02 | 2026-08-02 | EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| NPP | 2024-08-30 | 2027-08-30 | New pediatric HSCT and pediatric kidney-transplant populations approved on 2024-08-30; adult HSCT and adult kidney-transplant populations are not covered. | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| NPP | 2024-08-30 | 2027-08-30 | New pediatric HSCT and pediatric kidney-transplant populations approved on 2024-08-30; adult HSCT and adult kidney-transplant populations are not covered. | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-423 | 2023-06-05 | 2030-06-05 | FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-423 | 2023-06-05 | 2030-06-05 | FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-495 | 2024-08-30 | 2031-08-30 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-495 | 2024-08-30 | 2031-08-30 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-497 | 2024-08-30 | 2031-08-30 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
| Source |
| ODE-497 | 2024-08-30 | 2031-08-30 | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) | N | N | — | ODE-165 + ODE-423 + ODE-495 + ODE-497
Full coverage date: —
D-189 + ODE-423 + ODE-495 + ODE-497
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 |
|---|---|---|---|---|---|---|---|
| 216799 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ZYDUS PHARMS USA 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 | 2029-01-18 | CANONICAL_ANCHOR | Independent claim 1 chemical genus includes letermovir; claims 26-28 identify letermovir species and salts. Structures visually checked. USPTO PTE correction retained; no extra extension added to Orange Book date. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | New pediatric HSCT and pediatric kidney-transplant populations approved on 2024-08-30; adult HSCT and adult kidney-transplant populations are not covered. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) | Source |
| REGULATORY_EXCLUSIVITY | 2022-11-08 | SCOPE_CONTEXT | 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 | 2029-01-18 | 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.