Product profile · United States
VIREAD
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_TAIL; canonical rights assessment 2018 DEEP_REVIEW; POST_ANCHOR_TAIL.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5922695 | 2018-01-25 | DS/U/PED U-1275,U-248,U-250,U-256,U-999 | Y | N | TRUE_DS Independent compound claim 1 protects the antiviral phosphonomethoxy nucleotide prodrug genus containing tenofovir disoproxil; this is not only a crystal or dosage-form claim. | — | 2018-01-25 | — |
| US5935946 | 2018-01-25 | DS/DP/U/PED U-1275,U-248,U-250,U-256,U-999 | Y | N | TRUE_DS Independent formula claim 1 encompasses tenofovir disoproxil; crystalline-solid and diffraction limitations occur in narrower dependent claims, not all claims. | — | 2018-01-25 | — |
| US5977089 | 2018-01-25 | DS/DP/U/PED U-1275,U-248,U-250,U-256,U-999 | Y | N | TRUE_DS Independent claim 1 expressly claims (R)-bis(POC)PMPA, tenofovir disoproxil. Reissue family RE38333 is disclosed; the original number is retained as historical FDA listing evidence, not a certified present operative grant. | — | 2018-01-25 | — |
| US6043230 | 2018-01-25 | U/PED U-1275,U-248,U-250,U-256,U-999 | N | N | U The single claim is contacting a cell with a defined nucleotide analog. It is not a broad independent active-compound claim; cell contact is not equated automatically with every clinical HIV/HBV administration. No DS-equivalent promotion. | — | 2018-01-25 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | 2010-03-24 | 2013-03-24 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| PED | 2013-03-24 | 2013-09-24 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| M-95 | 2010-10-01 | 2013-10-01 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| PED | 2013-10-01 | 2014-04-01 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| NDF | 2012-01-18 | 2015-01-18 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| PED | 2015-01-18 | 2015-07-18 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| NPP | 2012-08-16 | 2015-08-16 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| M-128 | 2013-07-24 | 2016-07-24 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| ODE | 2010-03-24 | 2017-03-24 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| PED | 2017-03-24 | 2017-09-24 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
| NPP | 2018-12-11 | 2021-12-11 | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | N | N | — | M-95:2013-10-01 + NPP:2015-08-16 + NPP:2013-03-24 + NDF:2015-01-18 + ODE:2017-03-24 + M-128:2016-07-24 + NPP:2021-12-11
Full coverage date: —
| Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 (16)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2018-01-25 | CANONICAL_ANCHOR | Independent compound claim 1 protects the antiviral phosphonomethoxy nucleotide prodrug genus containing tenofovir disoproxil; this is not only a crystal or dosage-form claim. | Source |
| PATENT | 2018-01-25 | LISTING_CONTEXT | The single claim is contacting a cell with a defined nucleotide analog. It is not a broad independent active-compound claim; cell contact is not equated automatically with every clinical HIV/HBV administration. No DS-equivalent promotion. | Source |
| PATENT | 2018-01-25 | CANONICAL_ANCHOR | Independent formula claim 1 encompasses tenofovir disoproxil; crystalline-solid and diffraction limitations occur in narrower dependent claims, not all claims. | Source |
| PATENT | 2018-01-25 | CANONICAL_ANCHOR | Independent claim 1 expressly claims (R)-bis(POC)PMPA, tenofovir disoproxil. Reissue family RE38333 is disclosed; the original number is retained as historical FDA listing evidence, not a certified present operative grant. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Oral-powder NDF ended 2015-01-18 with PED to 2015-07-18: historical original-form scope only. The later HBV pediatric expansion prevents treating that original scope as the complete later label. ODE through 2017-03-24, PED to 2017-09-24, covers HIV ages 12 to under 18 only. NPP 2021-12-11 is the later pediatric HBV population, not adult HIV/HBV or all powder uses. M-95 covers adult decompensated HBV data; M-128 denotes clinical-trial results and its code alone cannot establish every indication. No full later-label combination is established. | Source |
| REGULATORY_STATUS | 2018-01-25 | DECISION_BASIS | POST_ANCHOR_TAIL; canonical rights assessment 2018 DEEP_REVIEW; POST_ANCHOR_TAIL. | 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.