Product profile · United States
XYZAL ALLERGY 24HR
· 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 |
|---|---|---|---|---|---|---|---|
| 090229 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2010-11-26 | — | SYNTHON BV | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090385 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-24 | — | GLENMARK PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090392 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-24 | — | DR REDDYS LABORATORIES LIMITED | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090199 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-08-22 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091264 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-06-29 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090362 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-01-31 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090486 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-03-26 | — | GRANULES INDIA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202046 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-09-17 | — | MICRO LABS LTD INDIA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203646 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-09 | — | SCIEGEN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203027 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-02-13 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 201653 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-06-26 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205564 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-01-11 | — | MACLEODS PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204323 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-12-20 | — | US ANTIBIOTICS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210375 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-01-19 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211551 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-20 | — | SANKALP LIFECARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211983 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-03-28 | — | PERRIGO R AND D CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213513 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-04-29 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211443 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-21 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204626 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-06 | — | IPCA 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 19 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 |
|---|---|---|---|---|---|---|
| 090229 / 001 | SYNTHON BV | FINAL_APPROVAL · FINAL_APPROVED | 2010-11-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090385 / 001 | GLENMARK PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090392 / 001 | DR REDDYS LABORATORIES LIMITED | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090199 / 001 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2011-08-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091264 / 001 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2012-06-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090362 / 001 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-01-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090486 / 001 | GRANULES INDIA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-03-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202046 / 001 | MICRO LABS LTD INDIA | FINAL_APPROVAL · FINAL_APPROVED | 2013-09-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203646 / 001 | SCIEGEN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203027 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-02-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 201653 / 001 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-06-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205564 / 001 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-01-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204323 / 001 | US ANTIBIOTICS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-12-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210375 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-01-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211551 / 001 | SANKALP LIFECARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211983 / 001 | PERRIGO R AND D CO | FINAL_APPROVAL · FINAL_APPROVED | 2019-03-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213513 / 001 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2020-04-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211443 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204626 / 001 | IPCA LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-06 | 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.