INTERMEZZO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA Final ANDA 204299/002 on 2015-06-03. ANDA 204299 corresponds to Intermezzo and FDA Paragraph IV records first approval 2015-06-03. Exact NDA/Product correspondence from 1.75mg / 3.5mg product matching.
Patent estate
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 |
|---|---|---|---|---|---|---|---|
| 204299 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2015-06-03 | — | NOVEL LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204503 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2016-11-18 | — | DR REDDYS LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204229 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-11 | — | PH HEALTH 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 3 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 |
|---|---|---|---|---|---|---|
| 204299 / 002 | NOVEL LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-06-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204503 / 002 | DR REDDYS LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-11-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204229 / 002 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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.