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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientARIPIPRAZOLE
Application typeNDA
Application207202
Product006
Dosage formTABLET
RouteORAL
Strength30MG
Approval date2017-11-13
Marketing statusDiscontinued
Status event—
ApplicantOTSUKA
Product source

Current GenericRadar decision

Year—
SelectionDISCONTINUED
ReviewFINAL
Anchor typeDISCONTINUATION
Anchor date—
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA—
Status event—

Discontinued in the original 2026-10-10 source. Actual marketing-discontinuation date is unverified. Evidence limits: actual discontinuation date unavailable; do not substitute the observation date or approval year.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
114769522026-04-28DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
114769522026-04-28DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91259392026-07-28U U-1749———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91259392026-07-28U U-1749———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
79780642026-09-14DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
79780642026-09-14DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
87593502027-03-02U U-1529———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
87593502027-03-02U U-1529———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
94445032027-11-19DP/U U-2169———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
94445032027-11-19DP/U U-2169———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91195542028-12-16DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91195542028-12-16DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
90607082029-03-05DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
90607082029-03-05DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
92580352029-03-05DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
92580352029-03-05DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
86748252029-04-09DP/U U-2170———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
86748252029-04-09DP/U U-2170———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89562882029-07-06DP/U U-2167———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89562882029-07-06DP/U U-2167———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
104411942029-07-26DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
104411942029-07-26DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89450052029-08-19DP/U U-2167———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89450052029-08-19DP/U U-2167———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
94333712029-09-15DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
94333712029-09-15DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
87181932029-12-05DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
87181932029-12-05DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91495772029-12-15DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
91495772029-12-15DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
88477662030-03-29DP/U U-2167———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
88477662030-03-29DP/U U-2167———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
85454022030-04-27DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
85454022030-04-27DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
81140212030-06-21DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
81140212030-06-21DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
114644232030-09-15DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
114644232030-09-15DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
99419312030-11-04DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
99419312030-11-04DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89614122030-11-17DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
89614122030-11-17DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
82589622030-11-25DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
82589622030-11-25DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
85472482030-12-18DP/U U-2167———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
85472482030-12-18DP/U U-2167———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
112293782031-07-11DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
112293782031-07-11DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
93204552031-12-15DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
93204552031-12-15DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
105175072032-06-13DP ————
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
105175072032-06-13DP ————
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
92689092033-10-15DP/U U-2168———
[GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———
92689092033-10-15DP/U U-2168———
Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

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

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

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
078613 / 006APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——BARR LABS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
078614 / 005APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——SUN PHARMA GLOBALNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
208260 / 006APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——PHARMTAK INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
078708 / 003FINAL_APPROVAL · FINAL_APPROVED2015-04-28—TEVA PHARMACEUTICALS USANEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
201519 / 006FINAL_APPROVAL · FINAL_APPROVED2015-04-28—TORRENT PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
202101 / 006FINAL_APPROVAL · FINAL_APPROVED2015-04-28—ALEMBIC PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
205064 / 006FINAL_APPROVAL · FINAL_APPROVED2015-04-28—HETERO LABS LTD UNIT VNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
078583 / 006FINAL_APPROVAL · FINAL_APPROVED2015-07-24—APOTEX INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
203908 / 006FINAL_APPROVAL · FINAL_APPROVED2015-10-08—AUROBINDO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
204838 / 006FINAL_APPROVAL · FINAL_APPROVED2016-06-17—AMNEAL PHARMACEUTICALSNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
206174 / 006FINAL_APPROVAL · FINAL_APPROVED2016-09-12—AJANTA PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
206383 / 006FINAL_APPROVAL · FINAL_APPROVED2016-09-29—SCIEGEN PHARMACEUTICALS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
204111 / 006FINAL_APPROVAL · FINAL_APPROVED2016-10-07—MACLEODS PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
206251 / 006FINAL_APPROVAL · FINAL_APPROVED2016-12-07—ACCORD HEALTHCARE INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
091279 / 006FINAL_APPROVAL · FINAL_APPROVED2017-01-09—AIPING PHARMACEUTICAL INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
202683 / 006FINAL_APPROVAL · FINAL_APPROVED2017-05-23—ORBION PHARMACEUTICALS PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
205363 / 006FINAL_APPROVAL · FINAL_APPROVED2017-12-04—PRINSTON PHARMACEUTICAL INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
206240 / 006FINAL_APPROVAL · FINAL_APPROVED2018-09-19—RISING PHARMA HOLDINGS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
090472 / 006FINAL_APPROVAL · FINAL_APPROVED2019-01-07—ZYDUS PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
207105 / 006FINAL_APPROVAL · FINAL_APPROVED2019-02-21—ALKEM LABORATORIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
203025 / 006FINAL_APPROVAL · FINAL_APPROVED2021-12-01—UNICHEM LABORATORIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
205589 / 006FINAL_APPROVAL · FINAL_APPROVED2024-03-18—LUPIN INCNEXACT_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 19 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
078708 / 003TEVA PHARMACEUTICALS USAFINAL_APPROVAL · FINAL_APPROVED2015-04-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
201519 / 006TORRENT PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2015-04-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
202101 / 006ALEMBIC PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2015-04-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
205064 / 006HETERO LABS LTD UNIT VFINAL_APPROVAL · FINAL_APPROVED2015-04-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
078583 / 006APOTEX INCFINAL_APPROVAL · FINAL_APPROVED2015-07-24 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
203908 / 006AUROBINDO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2015-10-08 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
204838 / 006AMNEAL PHARMACEUTICALSFINAL_APPROVAL · FINAL_APPROVED2016-06-17 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
206174 / 006AJANTA PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2016-09-12 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
206383 / 006SCIEGEN PHARMACEUTICALS INCFINAL_APPROVAL · FINAL_APPROVED2016-09-29 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
204111 / 006MACLEODS PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2016-10-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
206251 / 006ACCORD HEALTHCARE INCFINAL_APPROVAL · FINAL_APPROVED2016-12-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
091279 / 006AIPING PHARMACEUTICAL INCFINAL_APPROVAL · FINAL_APPROVED2017-01-09 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
202683 / 006ORBION PHARMACEUTICALS PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2017-05-23 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
205363 / 006PRINSTON PHARMACEUTICAL INCFINAL_APPROVAL · FINAL_APPROVED2017-12-04 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
206240 / 006RISING PHARMA HOLDINGS INCFINAL_APPROVAL · FINAL_APPROVED2018-09-19 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
090472 / 006ZYDUS PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2019-01-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
207105 / 006ALKEM LABORATORIES LTDFINAL_APPROVAL · FINAL_APPROVED2019-02-21 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
203025 / 006UNICHEM LABORATORIES LTDFINAL_APPROVAL · FINAL_APPROVED2021-12-01 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
205589 / 006LUPIN INCFINAL_APPROVAL · FINAL_APPROVED2024-03-18 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (27)
TypeDateRoleBasisSource
PATENT2026-04-28LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2026-07-28LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2026-09-14LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2027-03-02LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2027-11-19LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2028-12-16LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-03-05LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-03-05LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-04-09LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-07-06LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-07-26LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-08-19LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-09-15LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-12-05LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2029-12-15LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-03-29LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-04-27LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-06-21LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-09-15LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-11-04LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-11-17LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-11-25LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2030-12-18LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2031-07-11LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2031-12-15LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2032-06-13LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.Source
PATENT2033-10-15LISTING_CONTEXTNot used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification.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.