DrugPatentWatch Week in Review

RECENTLY REGISTERED 505(b)(2) TRIALS

505(b)(2)'s are a hybrid between a branded drug application and a generic drug application. They combine data from the branded drug maker with clinical trials for modifications to the they drug.

Use these to get advance notice of new formulations, new indications, or companies seeking to engineer solutions around patents.

FLUOXETINE HYDROCHLORIDE

Trial Title:Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New GuineaLead Sponsor:Oriol MitjaTrial Type:New IndicationTrial Status:Not yet recruitingStart Date:2022-05-01Phase:Phase 2/Phase 3Full Text:NCT05283954?at Clinicaltrials.govAll Clinical Trials:FLUOXETINE HYDROCHLORIDE?at DrugPatentWatchCHILDREN'S ADVIL

Trial Title:Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT CarcinomaLead Sponsor:National Cancer Institute (NCI)Trial Type:New CombinationTrial Status:Not yet recruitingStart Date:2022-04-29Phase:Phase 1/Phase 2Full Text:NCT05019716?at Clinicaltrials.govAll Clinical Trials:CHILDREN'S ADVIL?at DrugPatentWatchAMODIAQUINE HYDROCHLORIDE

Trial Title:A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine TetraphosphateLead Sponsor:Medicines for Malaria VentureTrial Type:New CombinationTrial Status:Not yet recruitingStart Date:2022-01-01Phase:Phase 1Full Text:NCT05160363?at Clinicaltrials.govAll Clinical Trials:AMODIAQUINE HYDROCHLORIDE?at DrugPatentWatchRECENTLY REGISTERED BIOSIMILAR TRIALS

Biosimilar clinical trials help you identify potential biosimilars well in advance of launch.

satralizumab

Trial Title:A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An InterventionLead Sponsor:Hoffmann-La RocheTrial Type:Trial Status:Not yet recruitingStart Date:2022-02-28Phase:Phase 4Full Text:NCT05269667 at Clinicaltrials.govAll Clinical Trials:satralizumab?at DrugPatentWatchrituximab

Trial Title:A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An InterventionLead Sponsor:Hoffmann-La RocheTrial Type:Trial Status:Not yet recruitingStart Date:2022-02-28Phase:Phase 4Full Text:NCT05269667 at Clinicaltrials.govAll Clinical Trials:rituximab?at DrugPatentWatchziv-aflibercept

Trial Title:Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled SyringeLead Sponsor:SandozTrial Type:Trial Status:Not yet recruitingStart Date:2022-01-25Phase:Phase 3Full Text:NCT05161806 at Clinicaltrials.govAll Clinical Trials:ziv-aflibercept?at DrugPatentWatchRECENT TENTATIVE APPROVALS

These tentative approvals may represent near-term generic launches.

LENALIDOMIDE

Sponsor:EUGIA PHARMA SPECLTSDosage Form:CAPSULE; ORALStrength:5MGApplication Number:213885Submission Date:2022-03-08Full Profile:LENALIDOMIDE?at DrugPatentWatchLENALIDOMIDE

Sponsor:EUGIA PHARMA SPECLTSDosage Form:CAPSULE; ORALStrength:25MGApplication Number:213885Submission Date:2022-03-08Full Profile:LENALIDOMIDE?at DrugPatentWatchLENALIDOMIDE

Sponsor:EUGIA PHARMA SPECLTSDosage Form:CAPSULE; ORALStrength:20MGApplication Number:213885Submission Date:2022-03-08Full Profile:LENALIDOMIDE?at DrugPatentWatchRECENT AUTHORIZED GENERICS

Authorized generics help you track competition in the generic market and additional supply-chain options.

DICLOFENAC POTASSIUM

Company:Leading Pharma, LLCDosage Form:CAPSULE;ORALStrength:25MGApplication Number:25MGApproval Date:2022-03-24Full Profile:DICLOFENAC POTASSIUM?at DrugPatentWatchZIPRASIDONE HYDROCHLORIDE

Company:REMEDYREPACK INC.Dosage Form:CAPSULE;ORALStrength:EQ 20MG BASEApplication Number:EQ 20MG BASEApproval Date:2022-03-02Full Profile:ZIPRASIDONE HYDROCHLORIDE?at DrugPatentWatchZIPRASIDONE HYDROCHLORIDE

Company:REMEDYREPACK INC.Dosage Form:CAPSULE;ORALStrength:EQ 40MG BASEApplication Number:EQ 40MG BASEApproval Date:2022-03-02Full Profile:ZIPRASIDONE HYDROCHLORIDE?at DrugPatentWatchMOST POPULAR CONTENT

RECENT PATENT LITIGATION

DrugPatentWatch tracks patent litigation to help you anticipate earlier-than-expected loss of exclusivity and generic entry opportunties which may emerge from patent invalidation or generic licensing.

Complete litigation histories also allow you to observe your opponents and improve your strategies, and they can also help you write stronger patents based on studying prior challenges.

District Courts

ALNYLAM PHARMACEUTICALS, INC. V. MODERNA, INC.

Court:District Court, D. DelawareCause:35:271 Patent InfringementDocket Number:1:22-cv-00335Patents:10,143,723, 10,172,808, 8,008,006, 9,000,002Drugs:Date Filed:2022-03-17Full Profile:ALNYLAM PHARMACEUTICALS, INC. V. MODERNA, INC.?at DrugPatentWatchMAYOR AND CITY COUNCIL OF BALTIMORE V. TEVA PHARMACEUTICALS INDUSTRIES LTD.

Court:District Court, D. New JerseyCause:15:2 Antitrust LitigationDocket Number:2:22-cv-01340Patents:9,402,874Drugs:COPAXONEDate Filed:2022-03-10Full Profile:MAYOR AND CITY COUNCIL OF BALTIMORE V. TEVA PHARMACEUTICALS INDUSTRIES LTD.?at DrugPatentWatchBAUSCH HEALTH IRELAND LIMITED V. MYLAN LABORATORIES LTD.

Court:District Court, N.D. West VirginiaCause:35:271 Patent InfringementDocket Number:1:22-cv-00020Patents:10,011,637, 7,041,786, 7,799,897, 8,637,451, 9,610,321, 9,616,097, 9,919,024, 9,925,231Drugs:COPAXONE, TRULANCEDate Filed:2022-03-08Full Profile:BAUSCH HEALTH IRELAND LIMITED V. MYLAN LABORATORIES LTD.?at DrugPatentWatchPatent Trial and Appeal Board (PTAB)

Patent 7,041,786

Type:IPRTrial Number:IPR2022-00722Petitioner:Mylan Pharmaceuticals Inc.Drugs:TRULANCEFiling Date:2022-03-21Full Profile:IPR2022-00722?at DrugPatentWatchPatent 10,138,279

Type:IPRTrial Number:IPR2022-00674Petitioner:TRUTEK CORP.Drugs:BIOTHRAXFiling Date:2022-03-07Full Profile:IPR2022-00674?at DrugPatentWatchPatent 8,114,833

Type:IPRTrial Number:IPR2022-00657Petitioner:Fresenius Kabi USA, LLCDrugs:OZEMPIC, SAXENDA, VICTOZAFiling Date:2022-03-03Full Profile:IPR2022-00657?at DrugPatentWatch