Product profile · United States

NESINA

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IngredientALOGLIPTIN BENZOATE

Application typeNDA

Application022271

Product003

Dosage formTABLET

RouteORAL

StrengthEQ 25MG BASE

Approval date2013-01-25

Marketing statusRX

Status event—

ApplicantTAKEDA PHARMS USA

Product source

Current GenericRadar decision

Year2028

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typePATENT

Anchor date2028-06-27

Patent anchor2028-06-27

Exclusivity anchor2018-01-25

Protection date2029-06-16

First Final ANDA—

Status event—

Rights after the canonical full-scope anchor require DEEP_REVIEW.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7807689	2028-06-27	DS/DP/U U-1337	Y	Y	TRUE_DS	—	—	—
7807689	2028-06-27	DS/DP/U U-1337	Y	Y	TRUE_DS Independent claim 1 claims alogliptin structure or acceptable salts without formulation/indication limitation. Claim 4 benzoate structure corrected by USPTO certificate; compound and corrected structure visually checked.	—	—	—
8697125	2029-06-16	DP —	N	N	FORMULATION	—	—	—
8697125	2029-06-16	DP —	N	N	FORMULATION Alogliptin granules with mannitol/microcrystalline cellulose and a magnesium-stearate tableting aid.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2013-01-25	2018-01-25	Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period.	Y	Y	2018-01-25	M-177 + M-300 Full coverage date: 2018-01-25	Source
M-177	2016-04-05	2019-04-05	INFORMATION ADDED TO THE LABELING DESCRIBING EXAMINE, A TRIAL EVALUATING CARDIOVASCULAR ISCHEMIC RISKS ASSOCIATED WITH ALOGLIPTIN USE IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK OF ISCHEMIC CARDIOVASCULAR DISEASE	N	N	—	M-177 + M-300 Full coverage date: —	Source
M-300	2023-07-27	2026-07-27	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST	N	N	—	M-177 + M-300 Full coverage date: —	Source
M-300	2023-07-27	2026-07-27	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST	N	N	—	M-177 + M-300 Full coverage date: —	Source

2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE

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

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
210213 / 003	APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED	—	—	MSN LABS PVT 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 0 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
No final-approval records are linked to this product.

Decision evidence (6)

Type	Date	Role	Basis	Source
PATENT	2028-06-27	CANONICAL_ANCHOR	Independent claim 1 claims alogliptin structure or acceptable salts without formulation/indication limitation. Claim 4 benzoate structure corrected by USPTO certificate; compound and corrected structure visually checked.	Source
PATENT	2029-06-16	FTO_TAIL	Alogliptin granules with mannitol/microcrystalline cellulose and a magnesium-stearate tableting aid.	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_CONTEXT	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_CONTEXT	INFORMATION ADDED TO THE LABELING DESCRIBING EXAMINE, A TRIAL EVALUATING CARDIOVASCULAR ISCHEMIC RISKS ASSOCIATED WITH ALOGLIPTIN USE IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK OF ISCHEMIC CARDIOVASCULAR DISEASE	Source
REGULATORY_EXCLUSIVITY	2018-01-25	CANONICAL_ANCHOR	Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period.	Source
REGULATORY_STATUS	2028-06-27	DECISION_BASIS	Rights after the canonical full-scope anchor require DEEP_REVIEW.	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.