Product profile · United States
REYATAZ
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS; canonical 2019 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5849911 | 2017-12-20 | DS/DP/U/PED U-167 | Y | N | TRUE_DS Independent compound claim1 protects the azahexane derivative genus encompassing atazanavir and its salts; Example46 and the REYATAZ active ingredient supply compound correspondence. | — | 2017-12-20 | — |
| US6087383 | 2019-06-21 | DS/DP/PED — | Y | N | TRUE_DS Claim1 independently protects the atazanavir bisulfate salt by chemical formula without mandatory XRPD/hydrate/polymorph limitations; claim2 is a dosage form containing that salt. REYATAZ label identifies atazanavir sulfate1:1, C38H52N6O7·H2SO4. Substance classification follows the broad standalone salt claim and exact approved API correspondence, not merely a salt title or official DS flag. | — | 2019-06-21 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2014-06-02 | 2017-06-02 | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | N | N | — | Source | |
| COMBINATION_NP_NPP_PED | 2015-09-24 | 2017-12-02 | Full exact oral-powder indication and population scope established by the FDA original approval and S-003 scope union. Date is the earlier necessary component extended endpoint. Evidence-based reviewed combination, not a separate FDA exclusivity award. Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Y | Y | 2017-12-02 | Source | |
| PED | 2017-06-03 | 2017-12-02 | ATTACHED_EXTENSION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | N | N | — | Source | |
| NPP | 2015-09-24 | 2018-09-24 | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | N | N | — | Source | |
| PED | 2018-09-25 | 2019-03-24 | ATTACHED_EXTENSION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | N | N | — | 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 (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2017-12-20 | LISTING_CONTEXT | Independent compound claim1 protects the azahexane derivative genus encompassing atazanavir and its salts; Example46 and the REYATAZ active ingredient supply compound correspondence. | Source |
| PATENT | 2019-06-21 | CANONICAL_ANCHOR | Claim1 independently protects the atazanavir bisulfate salt by chemical formula without mandatory XRPD/hydrate/polymorph limitations; claim2 is a dosage form containing that salt. REYATAZ label identifies atazanavir sulfate1:1, C38H52N6O7·H2SO4. Substance classification follows the broad standalone salt claim and exact approved API correspondence, not merely a salt title or official DS flag. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ATTACHED_EXTENSION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ATTACHED_EXTENSION; Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Source |
| REGULATORY_EXCLUSIVITY | 2017-12-02 | CANONICAL_ANCHOR | Full exact oral-powder indication and population scope established by the FDA original approval and S-003 scope union. Date is the earlier necessary component extended endpoint. Evidence-based reviewed combination, not a separate FDA exclusivity award. Original NP protects powder use from age 3 months at weight 10 to less than 25 kg. FDA S-003 approval of 2015-09-24 explicitly adds 5 to less than 10 kg and pediatric/adult patients unable to swallow capsules at higher weights. These two approval scopes jointly span all current oral-powder populations. PED is attached separately to NP and NPP. The complete-scope union ends when its first necessary component ends: 2017-12-02, not the later partial NPP/PED date 2019-03-24. The 2017 efficacy supplement adjusts capsule doses and does not add a new powder population. | Source |
| REGULATORY_STATUS | 2019-06-21 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS; canonical 2019 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. | 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.