Product profile · United States
ALLEGRA ALLERGY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Current official Orange Book exact product Type=OTC. Excluded under guideline section 4 OTC-only rule. Historical prescription status and switch effective date are not asserted.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
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. | ||||||||
2026-10-10 · 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 |
|---|---|---|---|---|---|---|---|
| 076447 / 009 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | TEVA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076707 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SANDOZ | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076970 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | RANBAXY | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076191 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2005-08-31 | — | BARR LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076447 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2005-09-01 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076502 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2006-04-11 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077081 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2007-04-16 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076502 / 008 | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-12 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076502 / 009 | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-12 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076447 / 008 | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-13 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077081 / 008 | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-21 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077081 / 009 | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-21 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091567 / 005 | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-06 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091567 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-06 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079112 / 005 | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-08 | — | TIME CAP LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079112 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-08 | — | TIME CAP LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202039 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-11-19 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204507 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-16 | — | SCIEGEN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204507 / 005 | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-16 | — | SCIEGEN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204097 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-19 | — | HETERO LABS LTD UNIT V | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210137 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-08-13 | — | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211075 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-18 | — | GRANULES INDIA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212971 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-02-24 | — | L PERRIGO CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219032 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-02-28 | — | CONTRACT PHARMACAL CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 220413 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2026-07-30 | — | DR REDDYS LABORATORIES LTD | 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 22 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 |
|---|---|---|---|---|---|---|
| 076191 / 003 | BARR LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2005-08-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076447 / 003 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2005-09-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076502 / 003 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2006-04-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077081 / 001 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2007-04-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076502 / 008 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076502 / 009 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076447 / 008 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-04-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077081 / 008 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077081 / 009 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091567 / 005 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091567 / 006 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 079112 / 005 | TIME CAP LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 079112 / 006 | TIME CAP LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2012-02-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202039 / 003 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-11-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204507 / 003 | SCIEGEN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204507 / 005 | SCIEGEN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204097 / 003 | HETERO LABS LTD UNIT V | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210137 / 001 | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-08-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211075 / 002 | GRANULES INDIA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212971 / 002 | L PERRIGO CO | FINAL_APPROVAL · FINAL_APPROVED | 2020-02-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219032 / 002 | CONTRACT PHARMACAL CORP | FINAL_APPROVAL · FINAL_APPROVED | 2025-02-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 220413 / 002 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2026-07-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PRODUCT_STATUS | — | EXCLUSION_BASIS | Exact application/product matched to current Orange Book Type=OTC; no patent or generic conclusion inferred. | 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.