Generic drug

Seoul Semiconductor Files Patent Infringement Lawsuit against Amazon in the European Unified Patent Court

Retrieved on: 
Tuesday, March 5, 2024

Seoul Semiconductor Co., Ltd. (“SSC”), a leading global innovator of LED products and technology, has announced that it filed a patent infringement lawsuit in the European Unified Patent Court against Amazon (Amazon Services Europe), the world's largest distribution company, seeking an injunction against the sale of infringing products.

Key Points: 
  • Seoul Semiconductor Co., Ltd. (“SSC”), a leading global innovator of LED products and technology, has announced that it filed a patent infringement lawsuit in the European Unified Patent Court against Amazon (Amazon Services Europe), the world's largest distribution company, seeking an injunction against the sale of infringing products.
  • Filing lawsuits in individual countries, however, was a less efficient way to enforce patents against infringing products.
  • The European Unified Patent Court, which was established in June 2023, has comprehensive jurisdiction over European patent litigation.
  • Injunction and damages orders for patent infringement from the Unified Patent Court can take effect simultaneously in 17 European countries, including Germany, France, and Italy.

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity

Retrieved on: 
Thursday, February 22, 2024

Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity.

Key Points: 
  • Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity.
  • Cosette will imminently commence commercial shipments, triggering the 180 days exclusivity.
  • This is Cosette’s 24th new product launch and our 3rd CGT approval in the last two years.
  • Cosette currently has several products in active development, and several complex product ANDAs pending FDA approval.

United Therapeutics Commences Litigation to Ensure Fairness in the Drug Review Process

Retrieved on: 
Wednesday, February 21, 2024

United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA).

Key Points: 
  • United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA).
  • In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency.
  • In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.
  • United Therapeutics believes this distinction is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with the FDA’s prior practices with which industry has complied for decades.

Microfluidic Devices Patent Monitoring Service 2024: Coverage of the 150 New Patent Families Published Each Month - ResearchAndMarkets.com

Retrieved on: 
Monday, February 19, 2024

In this broad technical area, more than 20,000 patent families related to microfluidics have been published worldwide, and over 150 new patent families are published each month.

Key Points: 
  • In this broad technical area, more than 20,000 patent families related to microfluidics have been published worldwide, and over 150 new patent families are published each month.
  • The microfluidic devices patent monitoring service allows you to take advantage of a monthly updated Excel file and benefit from both quarterly analysis reports and direct interaction with our analysts.
  • This useful Excel patent database allows for multi-criteria searches including priority date, patent assignees, claims, legal status of patents and technology segments.
  • Main patent applicants and their inventions, blocking patents, promising patents and key patents newly expired or abandoned will be highlighted.

PayRange Files Patent Infringement Lawsuit Against CSC ServiceWorks

Retrieved on: 
Wednesday, March 6, 2024

PORTLAND, Ore., March 6, 2024 /PRNewswire/ -- PayRange Inc., a pioneer in developing mobile payment solutions and hardware for automated retail, has filed a patent infringement lawsuit against CSC ServiceWorks, the largest US operator of laundry machines in multi-family housing and college dorms.

Key Points: 
  • PORTLAND, Ore., March 6, 2024 /PRNewswire/ -- PayRange Inc., a pioneer in developing mobile payment solutions and hardware for automated retail, has filed a patent infringement lawsuit against CSC ServiceWorks, the largest US operator of laundry machines in multi-family housing and college dorms.
  • PayRange is seeking damages estimated to be in excess of $108 million and a permanent injunction barring further infringement.
  • PayRange has alleged infringement of three patents in this lawsuit, which is in addition to four patents alleged in a still pending lawsuit filed against CSC ServiceWorks in March 2023.
  • Wilson Sonsini Goodrich & Rosati, PayRange's counsel on this matter, filed allegations stating that, "PayRange brings this case to hold CSC accountable for its willful infringement of PayRange's patent rights.

Boston Drug and Device Litigator Moves to Shook

Retrieved on: 
Thursday, February 29, 2024

BOSTON, Feb. 29, 2024 /PRNewswire/ -- Shook, Hardy & Bacon welcomes drug and device litigator Lisa Oliver White to the firm as partner.

Key Points: 
  • BOSTON, Feb. 29, 2024 /PRNewswire/ -- Shook, Hardy & Bacon welcomes drug and device litigator Lisa Oliver White to the firm as partner.
  • White will join Shook's world renowned Product Liability Litigation Practice and focus primarily on drug and device litigation.
  • "We're excited to bring Lisa to Shook," said Trial Partner Hildy Sastre from Miami, co-chair of the firm's product liability litigation team.
  • With White on board, Shook looks forward to expanding its presence in the drug and device space in the Boston market.

Cardinal Health annual research report examines milestone year in biosimilars

Retrieved on: 
Thursday, February 29, 2024

DUBLIN, Ohio, Feb. 29, 2024 /PRNewswire/ -- Today, Cardinal Health (NYSE: CAH) released its 2024 Biosimilars Report: insights on a pivotal year of evolution and expansion, an analysis of key recent economic, competitive, legislative and societal developments in biosimilars. The publication highlights legislative developments and new treatments, including adalimumab biosimilars. The report also provides the perspectives of retina specialists on biosimilars, ahead of the expected launch of multiple new biosimilars for retinal diseases.

Key Points: 
  • DUBLIN, Ohio, Feb. 29, 2024 /PRNewswire/ -- Today, Cardinal Health (NYSE: CAH) released its 2024 Biosimilars Report: insights on a pivotal year of evolution and expansion, an analysis of key recent economic, competitive, legislative and societal developments in biosimilars.
  • The report also provides the perspectives of retina specialists on biosimilars, ahead of the expected launch of multiple new biosimilars for retinal diseases.
  • The report examines a year of major developments in biosimilars, offering expert commentary and provider perspectives on a rapidly changing industry landscape.
  • With 2024 expected to be a critical year for retina biosimilars, Cardinal Health surveyed providers in ophthalmology to obtain perspectives that may influence adoption while highlighting continued obstacles to wider use of biosimilars.

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

Retrieved on: 
Friday, February 9, 2024

BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.

Key Points: 
  • BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.
  • Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia.
  • Trastuzumab is a biosimilar of Herceptin® and Bevacizumab is a biosimilar of Avastin®3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers.
  • OGIVRI® and ABEVMY® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company.

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

Retrieved on: 
Friday, February 9, 2024

BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.

Key Points: 
  • BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.
  • Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia.
  • Trastuzumab is a biosimilar of Herceptin® and Bevacizumab is a biosimilar of Avastin®3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers.
  • OGIVRI® and ABEVMY® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company.