DrugPatentWatch Week in Review

By / March 22, 2022
Copyright © DrugPatentWatch. Originally published at https://www.drugpatentwatch.com/blog/
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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 Guinea
Lead Sponsor:Oriol Mitja
Trial Type:New Indication
Trial Status:Not yet recruiting
Start Date:2022-05-01
Phase:Phase 2/Phase 3
Full Text:NCT05283954 at Clinicaltrials.gov
All Clinical Trials:FLUOXETINE HYDROCHLORIDE at DrugPatentWatch
CHILDREN’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 Carcinoma
Lead Sponsor:National Cancer Institute (NCI)
Trial Type:New Combination
Trial Status:Not yet recruiting
Start Date:2022-04-29
Phase:Phase 1/Phase 2
Full Text:NCT05019716 at Clinicaltrials.gov
All Clinical Trials:CHILDREN’S ADVIL at DrugPatentWatch
AMODIAQUINE HYDROCHLORIDE
Trial Title:A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate
Lead Sponsor:Medicines for Malaria Venture
Trial Type:New Combination
Trial Status:Not yet recruiting
Start Date:2022-01-01
Phase:Phase 1
Full Text:NCT05160363 at Clinicaltrials.gov
All Clinical Trials:AMODIAQUINE HYDROCHLORIDE at DrugPatentWatch
RECENTLY 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 Intervention
Lead Sponsor:Hoffmann-La Roche
Trial Type:
Trial Status:Not yet recruiting
Start Date:2022-02-28
Phase:Phase 4
Full Text:NCT05269667 at Clinicaltrials.gov
All Clinical Trials:satralizumab at DrugPatentWatch
rituximab
Trial Title:A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Lead Sponsor:Hoffmann-La Roche
Trial Type:
Trial Status:Not yet recruiting
Start Date:2022-02-28
Phase:Phase 4
Full Text:NCT05269667 at Clinicaltrials.gov
All Clinical Trials:rituximab at DrugPatentWatch
ziv-aflibercept
Trial Title:Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
Lead Sponsor:Sandoz
Trial Type:
Trial Status:Not yet recruiting
Start Date:2022-01-25
Phase:Phase 3
Full Text:NCT05161806 at Clinicaltrials.gov
All Clinical Trials:ziv-aflibercept at DrugPatentWatch
RECENT TENTATIVE APPROVALS

These tentative approvals may represent near-term generic launches.

LENALIDOMIDE
Sponsor:EUGIA PHARMA SPECLTS
Dosage Form:CAPSULE; ORAL
Strength:10MG
Application Number:213885
Submission Date:2022-03-08
Full Profile:LENALIDOMIDE at DrugPatentWatch
LENALIDOMIDE
Sponsor:EUGIA PHARMA SPECLTS
Dosage Form:CAPSULE; ORAL
Strength:5MG
Application Number:213885
Submission Date:2022-03-08
Full Profile:LENALIDOMIDE at DrugPatentWatch
LENALIDOMIDE
Sponsor:EUGIA PHARMA SPECLTS
Dosage Form:CAPSULE; ORAL
Strength:25MG
Application Number:213885
Submission Date:2022-03-08
Full Profile:LENALIDOMIDE at DrugPatentWatch
RECENT AUTHORIZED GENERICS

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

ZIPRASIDONE HYDROCHLORIDE
Company:REMEDYREPACK INC.
Dosage Form:CAPSULE;ORAL
Strength:EQ 20MG BASE
Application Number:EQ 20MG BASE
Approval Date:2022-03-02
Full Profile:ZIPRASIDONE HYDROCHLORIDE at DrugPatentWatch
ZIPRASIDONE HYDROCHLORIDE
Company:REMEDYREPACK INC.
Dosage Form:CAPSULE;ORAL
Strength:EQ 40MG BASE
Application Number:EQ 40MG BASE
Approval Date:2022-03-02
Full Profile:ZIPRASIDONE HYDROCHLORIDE at DrugPatentWatch
ZIPRASIDONE HYDROCHLORIDE
Company:REMEDYREPACK INC.
Dosage Form:CAPSULE;ORAL
Strength:EQ 60MG BASE
Application Number:EQ 60MG BASE
Approval Date:2022-03-02
Full Profile:ZIPRASIDONE HYDROCHLORIDE at DrugPatentWatch
MOST POPULAR CONTENT
Most Popular Pharmaceutical Drugs Searched Last Week
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. Delaware
Cause:35:271 Patent Infringement
Docket Number:1:22-cv-00335
Patents:10,143,723, 10,172,808, 8,008,006, 9,000,002
Drugs:
Date Filed:2022-03-17
Full Profile:ALNYLAM PHARMACEUTICALS, INC. V. MODERNA, INC. at DrugPatentWatch
MAYOR AND CITY COUNCIL OF BALTIMORE V. TEVA PHARMACEUTICALS INDUSTRIES LTD.
Court:District Court, D. New Jersey
Cause:15:2 Antitrust Litigation
Docket Number:2:22-cv-01340
Patents:9,402,874
Drugs:COPAXONE
Date Filed:2022-03-10
Full Profile:MAYOR AND CITY COUNCIL OF BALTIMORE V. TEVA PHARMACEUTICALS INDUSTRIES LTD. at DrugPatentWatch
BAUSCH HEALTH IRELAND LIMITED V. MYLAN LABORATORIES LTD.
Court:District Court, N.D. West Virginia
Cause:35:271 Patent Infringement
Docket Number:1:22-cv-00020
Patents:10,011,637, 7,041,786, 7,799,897, 8,637,451, 9,610,321, 9,616,097, 9,919,024, 9,925,231
Drugs:COPAXONE, TRULANCE
Date Filed:2022-03-08
Full Profile:BAUSCH HEALTH IRELAND LIMITED V. MYLAN LABORATORIES LTD. at DrugPatentWatch
Patent Trial and Appeal Board (PTAB)

Patent 10,138,279
Type:IPR
Trial Number:IPR2022-00674
Petitioner:TRUTEK CORP.
Drugs:BIOTHRAX
Filing Date:2022-03-07
Full Profile:IPR2022-00674 at DrugPatentWatch
Patent 8,114,833
Type:IPR
Trial Number:IPR2022-00657
Petitioner:Fresenius Kabi USA, LLC
Drugs:OZEMPIC, SAXENDA, VICTOZA
Filing Date:2022-03-03
Full Profile:IPR2022-00657 at DrugPatentWatch
Patent 8,580,264
Type:IPR
Trial Number:IPR2022-00578
Petitioner:Celltrion, Inc.
Drugs:ACTEMRA, RITUXAN, RITUXAN HYCELA
Filing Date:2022-02-21
Full Profile:IPR2022-00578 at DrugPatentWatch

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