GenericRadar
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Product profile · United States

NUZYRA

 ·  Patent Litigation & Settlement History ↓

IngredientOMADACYCLINE TOSYLATE
Application typeNDA
Application209816
Product001
Dosage formTABLET
RouteORAL
StrengthEQ 150MG BASE
Approval date2018-10-02
Marketing statusPrescription
Status event—
ApplicantPARATEK PHARMS
Product source

Current GenericRadar decision

Year2030
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2030-10-24
Patent anchor2030-10-24
Exclusivity anchor2028-10-02
Protection date2037-10-31
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:209816:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
101240142029-03-05U U-2449NNU
| B1C03P8 issued-claim review2026-10-15: U
———
101240142029-03-05ORANGE_BOOK U-2449NNU
English description not available.
———
97243582029-03-05U U-1569NNU
| B1C03P8 issued-claim review2026-10-15: U
———
97243582029-03-05ORANGE_BOOK U-1569NNU
English description not available.
———
83836102030-09-23DS —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
83836102030-09-23ORANGE_BOOK —NNDP
English description not available.
———
92657402030-10-24DP/U U-1569NYU
| B1C03P8 issued-claim review2026-10-15: U
———
92657402030-10-24ORANGE_BOOK U-1569NYU
English description not available.
———
93144752031-03-18DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
93144752031-03-18ORANGE_BOOK —NNDP
English description not available.
———
101118902037-08-03U U-2444NNU
| B1C03P8 issued-claim review2026-10-15: U
———
101118902037-08-03ORANGE_BOOK U-2444NNU
English description not available.
———
103838842037-10-31U U-2576NNU
| B1C03P8 issued-claim review2026-10-15: U
———
103838842037-10-31ORANGE_BOOK U-2576NNU
English description not available.
———
108355422037-10-31U U-2576NNU
| B1C03P8 issued-claim review2026-10-15: U
———
108355422037-10-31ORANGE_BOOK U-2576NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2018-10-022023-10-02English description not available.YY2023-10-02—Source
NCE2018-10-022023-10-02English description not available.YY2023-10-02
GAIN
Full coverage date: 2023-10-02
Source
GAIN2018-10-022028-10-02English description not available.YY2028-10-02—Source
GAIN2018-10-022028-10-02English description not available.YY2028-10-02
GAIN
Full coverage date: 2028-10-02
Source
M-3202026-05-132029-05-13English description not available.NN——Source
M-3202026-05-132029-05-13English description not available.NN—
GAIN
Full coverage date: —
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 (12)
TypeDateRoleBasisSource
PATENT2029-03-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-03-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-09-23HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-10-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-03-18FTO_TAILEnglish description not available.Source
PATENT2037-08-03FTO_TAILEnglish description not available.Source
PATENT2037-10-31FTO_TAILEnglish description not available.Source
PATENT2037-10-31FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2030-10-24CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:209816:001; 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.