GenericRadar
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Product profile · United States

REVLIMID

 ·  Patent Litigation & Settlement History ↓

IngredientLENALIDOMIDE
Application typeNDA
Application021880
Product005
Dosage formCAPSULE
RouteORAL
Strength2.5MG
Approval date2011-12-21
Marketing statusPrescription
Status event—
ApplicantBRISTOL MYERS SQUIBB
Product source

Current GenericRadar decision

Year2021
SelectionEXISTING_GENERIC
ReviewDISQUALIFIED
Anchor typeFINAL_ANDA
Anchor date2021-10-14
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2021-10-14
Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
74658002027-04-27DS/DP ————
———
87419292028-03-08U U-1983———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
ODE-241—2026-05-28————Source
ODE-245—2026-05-28————Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
209348 / 001FINAL_APPROVAL · FINAL_APPROVED2021-10-14—DR REDDYS LABORATORIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
201452 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-06—ARROW INTERNATIONAL LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
210154 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-06—ZYDUS PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
210480 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-06—ALVOGEN INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211846 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-06—SUN PHARMACEUTICAL INDUSTRIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
213885 / 001FINAL_APPROVAL · FINAL_APPROVED2023-03-06—EUGIA PHARMA SPECIALITIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
213912 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-06—MYLAN PHARMACEUTICALS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214618 / 001FINAL_APPROVAL · FINAL_APPROVED2023-03-06—CIPLA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211022 / 005FINAL_APPROVAL · FINAL_APPROVED2023-03-07—APOTEX INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
212414 / 001FINAL_APPROVAL · FINAL_APPROVED2023-05-11—HETERO LABS LTD UNIT VNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
217265 / 001FINAL_APPROVAL · FINAL_APPROVED2024-02-22—QILU PHARMACEUTICAL CO LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
217281 / 001FINAL_APPROVAL · FINAL_APPROVED2024-09-11—NOVUGEN ONCOLOGY SDN BHDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
216213 / 001FINAL_APPROVAL · FINAL_APPROVED2025-01-31—AMNEAL EU LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
215759 / 001FINAL_APPROVAL · FINAL_APPROVED2025-03-03—BIOCON PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
217554 / 001FINAL_APPROVAL · FINAL_APPROVED2025-05-22—DEVA HOLDING ASNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214398 / 001FINAL_APPROVAL · FINAL_APPROVED2025-09-16—LUPIN LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218872 / 001FINAL_APPROVAL · FINAL_APPROVED2025-11-14—ACCORD HEALTHCARE INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
213405 / 005FINAL_APPROVAL · FINAL_APPROVED2026-02-10—TORRENT PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource

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.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast 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 / productApplicantEvent / status First marketed Product mappingSourceLast 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 / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast 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 / productApplicantEvent / status Certification event date Product mappingSourceLast verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 18 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / productApplicantEvent / status Final approval date Product mappingSourceLast verified
209348 / 001DR REDDYS LABORATORIES LTDFINAL_APPROVAL · FINAL_APPROVED2021-10-14 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
201452 / 005ARROW INTERNATIONAL LTDFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
210154 / 005ZYDUS PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
210480 / 005ALVOGEN INCFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211846 / 005SUN PHARMACEUTICAL INDUSTRIES LTDFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
213885 / 001EUGIA PHARMA SPECIALITIES LTDFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
213912 / 005MYLAN PHARMACEUTICALS INCFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214618 / 001CIPLA LTDFINAL_APPROVAL · FINAL_APPROVED2023-03-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211022 / 005APOTEX INCFINAL_APPROVAL · FINAL_APPROVED2023-03-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
212414 / 001HETERO LABS LTD UNIT VFINAL_APPROVAL · FINAL_APPROVED2023-05-11 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
217265 / 001QILU PHARMACEUTICAL CO LTDFINAL_APPROVAL · FINAL_APPROVED2024-02-22 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
217281 / 001NOVUGEN ONCOLOGY SDN BHDFINAL_APPROVAL · FINAL_APPROVED2024-09-11 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
216213 / 001AMNEAL EU LTDFINAL_APPROVAL · FINAL_APPROVED2025-01-31 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
215759 / 001BIOCON PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2025-03-03 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
217554 / 001DEVA HOLDING ASFINAL_APPROVAL · FINAL_APPROVED2025-05-22 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214398 / 001LUPIN LTDFINAL_APPROVAL · FINAL_APPROVED2025-09-16 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218872 / 001ACCORD HEALTHCARE INCFINAL_APPROVAL · FINAL_APPROVED2025-11-14 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
213405 / 005TORRENT PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2026-02-10 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (1)
TypeDateRoleBasisSource
GENERIC2021-10-14TERMINAL_GENERIC_BASISExact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.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.