Product profile · United States
CHILDREN'S ALLEGRA HIVES
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
OTC_ONLY_PRODUCT. OTC/diagnostic business-scope exclusion; marketing and generic facts preserved separately.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6187791 | 2012-05-11 | U U-1158 | N | N | DP_U Treatment of patients with cardiac-risk considerations; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6399632 | 2012-05-11 | U U-1158 | N | N | DP_U Treatment in impaired terfenadine metabolism; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US5578610 | 2013-11-26 | DS/DP/U U-1158 | Y | N | TRUE_DS Fexofenadine within the claimed piperidine compound structure. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US7138524 | 2014-05-18 | DS — | N | N | SOLID_STATE Fexofenadine Form I anhydrous crystal. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US5738872 | 2015-02-28 | DP — | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6037353 | 2017-03-14 | U U-1158 | N | N | DP_U Antihistamine treatment in hepatic impairment; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6723348 | 2021-11-26 | DP — | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · 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 |
|---|---|---|---|---|---|---|---|
| 202978 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-01-18 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 202978 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2013-01-18 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 2 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 |
|---|---|---|---|---|---|---|
| 202978 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-01-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 202978 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVAL | 2013-01-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2013-01-18 | CONFIRMED_FINAL_GENERIC_HISTORY | Exact Final ANDA202978/001 -> NDA021909/003 | Source |
| PATENT | 2012-05-11 | LISTING_CONTEXT | Treatment in impaired terfenadine metabolism; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2012-05-11 | LISTING_CONTEXT | Treatment of patients with cardiac-risk considerations; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2013-11-26 | CANONICAL_ANCHOR | Fexofenadine within the claimed piperidine compound structure. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2014-05-18 | FTO_TAIL | Fexofenadine Form I anhydrous crystal. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2015-02-28 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2017-03-14 | FTO_TAIL | Antihistamine treatment in hepatic impairment; patient subgroup, not all approved users. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2021-11-26 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| REGULATORY_STATUS | — | DECISION_BASIS | OTC_ONLY_PRODUCT. OTC/diagnostic business-scope exclusion; marketing and generic facts preserved separately. | 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.