GenericRadar
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Product profile · United States

WEGOVY HD

 ·  Patent Litigation & Settlement History ↓

IngredientSEMAGLUTIDE
Application typeNDA
Application215256
Product006
Dosage formSOLUTION
RouteSUBCUTANEOUS
Strength7.2MG/0.75ML (7.2MG/0.75ML)
Approval date2026-03-19
Marketing statusPrescription
Status event—
ApplicantNOVO
Product source

Current GenericRadar decision

Year2038
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2038-10-10
Patent anchor2038-10-10
Exclusivity anchor2029-03-19
Protection date2041-02-17
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:215256:006; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
81293432031-12-05DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
81293432031-12-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
97640032033-06-21U U-4418NNU
| B1C03P8 issued-claim review2026-10-15: U
———
97640032033-06-21ORANGE_BOOK U-4418NNU
English description not available.
———
108886052038-08-24DP/U U-4418NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
108886052038-08-24ORANGE_BOOK U-4418NNDP
English description not available.
———
117521982038-08-24DP/U U-4418NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
117521982038-08-24ORANGE_BOOK U-4418NNDP
English description not available.
———
122140172038-08-24DP/U U-4418NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
122140172038-08-24ORANGE_BOOK U-4418NNDP
English description not available.
———
120297792038-10-10U U-4418NNU
| B1C03P8 issued-claim review2026-10-15: U
———
120297792038-10-10ORANGE_BOOK U-4418NNU
English description not available.
———
125515362038-10-10U U-4418NYU
| B1C03P8 issued-claim review2026-10-15: U
———
125515362038-10-10ORANGE_BOOK U-4418NYU
English description not available.
———
113181912041-02-17DP/U U-4418NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
113181912041-02-17ORANGE_BOOK U-4418NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NS2026-03-192029-03-19English description not available.YY2029-03-19—Source
NS2026-03-192029-03-19English description not available.YY2029-03-19
NS
Full coverage date: 2029-03-19
Source

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

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

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 0 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
No final-approval records are linked to this product.
Decision evidence (10)
TypeDateRoleBasisSource
PATENT2031-12-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-06-21HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-08-24NOT_APPLICABLE_TO_EXACT_PRODUCTEnglish description not available.Source
PATENT2038-08-24HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-08-24HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-10CANONICAL_ANCHOREnglish description not available.Source
PATENT2041-02-17FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-10-10CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:215256:006; exact Final ANDA not verified; not proof of generic absenceSource
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.