Orange Book

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023
US Foods, Abbreviated New Drug Application, United States Court of Appeals for the Federal Circuit, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, SUN, ORX, Orexo, CIII, SEK, Tablet, United States district court, Orange Book, District court, Patent, United States District Court for the Eastern District of Texas, Food, Generic drug, Appeal

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Former FDA Chief Counsel Dan Troy Joins BRG as Managing Director

Retrieved on: 
Wednesday, July 12, 2023
Office of Inspector General, U.S. Department of Health and Human Services, White House, GSK, BRG, Justice, Legends (Above the Law album), Human services, American Bar Association, Foreign Corrupt Practices Act, Sidley Austin, White, First, Organization, Orange Book, American Bar Association Model Rules of Professional Conduct, Real-time, GSK plc, Food and Drug Administration, Financial Times, Wiley Rein, American Law Institute, Knowledge, Pharmaceutical Research and Manufacturers of America, Security (finance), Fraud, FDA, First Amendment to the United States Constitution, Berkeley Research Group, Commerce, Pharmaceutical industry

WASHINGTON, July 12, 2023 /PRNewswire/ -- Global expert services and consulting firm Berkeley Research Group (BRG) announced today that former Federal Drug Administration (FDA) Chief Counsel Dan Troy has joined the firm's Washington, D.C. office as a managing director in its Health Analytics practice. His pharmaceutical and regulatory expertise will bolster the practice's ability to address FDA issues on behalf of its clients. 

Key Points: 
  • WASHINGTON, July 12, 2023 /PRNewswire/ -- Global expert services and consulting firm Berkeley Research Group (BRG) announced today that former Federal Drug Administration (FDA) Chief Counsel Dan Troy has joined the firm's Washington, D.C. office as a managing director in its Health Analytics practice.
  • He served as chief counsel at the FDA and spent a decade as general counsel and senior vice president of GSK plc.
  • At BRG, Troy will work with law firms and pharmaceutical companies to provide expert witness testimony on FDA regulatory and related matters.
  • At the FDA, Troy was a primary liaison to the White House and the Department of Health and Human Services.

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023
US Foods, Abbreviated New Drug Application, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, ORX, CIII, Tablet, Orange Book, United States district court, Patent, Patient, Food, Generic drug, Orexo

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023
US Foods, Abbreviated New Drug Application, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, ORX, CIII, Tablet, Orange Book, United States district court, Patent, Patient, Food, Generic drug, Orexo

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

Marius Pharmaceuticals Announces Two Key Patents Related to KYZATREX™ in FDA Orange Book

Retrieved on: 
Friday, June 9, 2023
The Orange Book, Testosterone, Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Hypogonadism, Food, Safety, Pharmaceutical industry

RALEIGH, N.C., June 09, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on therapies designed for hypogonadism or testosterone deficiency, announced that its U.S. patents related to KYZATREX™ (testosterone undecanoate), No.

Key Points: 
  • RALEIGH, N.C., June 09, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on therapies designed for hypogonadism or testosterone deficiency, announced that its U.S. patents related to KYZATREX™ (testosterone undecanoate), No.
  • 11617758B2, are now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”
    These patents represent significant milestones for Marius Pharmaceuticals as they underpin the broad coverage of KYZATREX's™ advanced delivery system.
  • The Orange Book lists patents for FDA-approved drugs that have been determined to be safe and effective for public use.
  • "We are glad to announce the listing of these two pivotal patents related to KYZATREX™ in the FDA Orange Book," said Shalin Shah, CEO of Marius Pharmaceuticals.

Cosette Pharmaceuticals Acquires Intrarosa® from Endoceutics, Inc.

Retrieved on: 
Thursday, June 8, 2023
Health, Consumer, Women, Other Health, General Health, Pharmaceutical, Cardiology, Dyspareunia, BSE, Partnership, Vaginal discharge, Vulvar Crohn's disease, Woman, Multimedia, Medication, Orange Book, Acquisition, Lacerum, Patent, Menopause, VVA, Pharmaceutical industry, Avia, EU

Cosette Pharmaceuticals, Inc. ("Cosette"), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of the global rights to Intrarosa® from Endoceutics, Inc., a subsidiary of Endorecherche, Inc.

Key Points: 
  • Cosette Pharmaceuticals, Inc. ("Cosette"), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of the global rights to Intrarosa® from Endoceutics, Inc., a subsidiary of Endorecherche, Inc.
  • The transaction includes 108 issued and pending patents across the globe with the latest expiring in 2033 including 3 Orange Book listed patents.
  • View the full release here: https://www.businesswire.com/news/home/20230608005297/en/
    Apurva Saraf, President and CEO of Cosette stated, “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation.
  • In partnership with MSH Pharma Inc., Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa®.

Optinose Reports First Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Thursday, May 11, 2023
ENT, Patent, Exhalation delivery system, Ear, Conference call, OPTN, General Administration of Sport of China, Telephone, Prescription Drug User Fee Act, GAAP, Research, Nose, Orange Book, United States Patent and Trademark Office, Sinusitis, Patient, Exhalation, Approved Drug Products with Therapeutic Equivalence Evaluations, PDUFA, Webcast, FDA, MPH, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Cryptocurrency, MD, Conference

YARDLEY, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended March 31, 2023, and provided operational updates.

Key Points: 
  • Conference call and webcast to be held today at 8:00 a.m. Eastern Time
    YARDLEY, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended March 31, 2023, and provided operational updates.
  • “We are pleased with the progress we made in the first quarter of 2023 towards our strategic objectives," stated CEO Ramy Mahmoud, MD, MPH.
  • The Company expects XHANCE net revenues for the full year of 2023 to be between $62.0 to $68.0 million.
  • Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

Amicus Therapeutics Announces First Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Wednesday, May 10, 2023
Fabry, Loss, Table, Civil service commission, CER, CER1, European Directive on Traditional Herbal Medicinal Products, Amicus, Glycogen storage disease type II, GAAP, Committee, PIN, EAMS, Acquisition, Patient, Physician, Cipaglucosidase alfa, European, Growth, WuXi Biologics, Depreciation, Diagnosis, Committee for Medicinal Products for Human Use, Orange Book, Amicus Therapeutics, FDA, Therapy, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, Wuxi, CHMP, Pharmaceutical industry, Bank, Video game, Cryptocurrency, EU, Migalastat

In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.

Key Points: 
  • In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.
  • Total GAAP operating expenses of $117.0 million for the first quarter 2023 decreased as compared to $146.5 million for the first quarter 2022.
  • ET to discuss the first quarter 2023 financial results and corporate updates.
  • A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com .

Exelixis Announces First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 9, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Orange, Share repurchase, District court, Investigational New Drug, Royalty payment, Patent, Checkmate, Ipilimumab, News, Software, Calendar, MSN, DC, Pharmacokinetics, Orange Book, IMDC, FDA, IND, Conference, Safety, 1836 U.S. Patent Office fire, Allele, Cabozantinib, Antibody, PIN, Webcast, Acceleration, RCC, Exelixis, OS, Trial of the century, ASCO, American Society of Clinical Oncology, ANDA, United States District Court for the Eastern District of Texas, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Douglas v. U.S. District Court ex rel Talk America, Tumor microenvironment, Society, Food, Nivolumab, Online shopping, Pharmaceutical industry, Patient

Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2023, Exelixis earned $32.7 million in royalty revenues.
  • Cabozantinib Data at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (ASCO GU 2023).
  • This IND clearance triggered a $35.0 million milestone payment to Sairopa, paid in the first quarter of 2023.
  • Exelixis management will discuss the company’s financial results for the first quarter of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Lantern Pharma Reports First Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Tuesday, May 9, 2023
Other Health, Research, Pharmaceutical, Oncology, Technology, Artificial Intelligence, Clinical Trials, Science, Biotechnology, Other Technology, Other Science, Health, Sherpa, Pancreatic cancer, Computational biology, Patent, US Foods, DNA, Human, Brain, AACR, Central nervous system, GBM, DDR, United States Patent and Trademark Office, DHL, NHL, Traffic barrier, NSCLC, Prostate, Lung cancer, CNS, Glioblastoma, Actuate, Orange Book, Phase 10, BBB, Metadata, Permeability, Patient, Machine learning, Mantle cell lymphoma, Algorithm, Starlight, Cancer, MCL, Poster, AI, FDA, Therapy, PARP, IND, Food, D, Pharmaceutical industry, Medical imaging, Cryptocurrency, Olaparib, Lantern

Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("AI") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("AI") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the first quarter ended March 31, 2023.
  • First Quarter 2023 Financial Overview:
    Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $51.5 million as of March 31, 2023, compared to approximately $55.2 million as of December 31, 2022.
  • G&A Expenses: General and administrative expenses were approximately $1.7 million for the quarter ended March 31, 2023, compared to approximately $1.4 million for the quarter ended March 31, 2022.
  • Earnings Call and Webinar Details:
    Lantern will host its first quarter 2023 earnings call and webinar today, Tuesday, May 9, 2023 at 4:30 p.m.