Orange Book

U.S. product recalls surge 11% in 2023 to hit seven-year high

Retrieved on: 
Thursday, February 15, 2024
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MEMPHIS, Tenn., Feb. 15, 2024 /PRNewswire/ -- U.S. product recalls reached a seven-year high in 2023, increasing 11% from 2022 to 2023. According to Sedgwick brand protection's 2024 State of the Nation Recall Index report, there were 3,301 recall events in 2023 across the five industries tracked by Sedgwick. While the number of defective units recalled in 2023 did not surpass one billion, as seen in the previous two years, there were still 759 million units recalled. Although the number of defective units decreased nearly 50% from 2022, the number of recall events has now increased for two consecutive years. Companies need to remain vigilant about product safety.

Key Points: 
  • MEMPHIS, Tenn., Feb. 15, 2024 /PRNewswire/ -- U.S. product recalls reached a seven-year high in 2023, increasing 11% from 2022 to 2023.
  • This special edition of Sedgwick's Recall Index report goes beyond its traditional quarterly reviews, offering a year-in-review analysis of 2023 recall data and product safety trends.
  • Automotive recalls decreased for the second consecutive year in 2023, falling from 955 in 2022 to 916.
  • The number of consumer product recalls reached a 12-year high in 2023, with 322 events.

Calliditas provides patent update

Retrieved on: 
Tuesday, February 13, 2024
Orange Book, Sustainability, Capsule, Person, Budesonide, Patent, CALT, Immunoglobulin A, IgA nephropathy, The Orange Book

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.

Key Points: 
  • STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.
  • This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.
  • The patent covers a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name "NEFECON®".
  • Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.

Calliditas provides patent update

Retrieved on: 
Tuesday, February 13, 2024
Orange Book, Sustainability, Capsule, Person, Budesonide, Patent, CALT, Immunoglobulin A, IgA nephropathy, The Orange Book

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.

Key Points: 
  • STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no.
  • This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.
  • The patent covers a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name "NEFECON®".
  • Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.

Supernus Wins Infringement and Validity Case on Trokendi XR® against Torrent

Retrieved on: 
Monday, February 5, 2024
Patent, The Orange Book, New Drug Application, Intellectual property, Central nervous system, FDA, Orange Book, Torrent, District court, Food, CNS, Torrent Pharmaceuticals, IP, Topiramate

ROCKVILLE, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos.

Key Points: 
  • ROCKVILLE, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos.
  • 8,992,989; 9,549,940; and 9,622,983 by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking permission to market a generic version of Trokendi XR® before the expiration of Supernus’ patents.
  • “We are very pleased with the District Court’s ruling that Torrent infringed our Trokendi XR® patents and the reaffirmation of the validity of those patents,” stated Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
  • The Orange Book lists a total of ten patents as covering Trokendi XR.

Eagle Pharmaceuticals Provides Update on Bendamustine Intellectual Property Portfolio

Retrieved on: 
Thursday, January 18, 2024
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WOODCLIFF LAKE, N.J., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided an update on its bendamustine intellectual property portfolio.

Key Points: 
  • WOODCLIFF LAKE, N.J., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided an update on its bendamustine intellectual property portfolio.
  • Eagle is also announcing that the U.S. Patent and Trademark Office has granted U.S. Patent Nos.
  • 11844783 (the “‘783 patent”) and 11872214 (the “‘214 patent”) covering Eagle’s innovative bendamustine liquid formulations.
  • Eagle cannot predict the timing or ultimate outcome of the litigation described above or the impact of this litigation on its business.

Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY® (ponesimod) in the U.S.

Retrieved on: 
Friday, January 26, 2024
Multiple sclerosis, Janssen, Actelion, Orange Book, Food, Ponesimod, Vanda, The Orange Book, Patent, Pharmaceutical industry

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.

Key Points: 
  • WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.
  • When issued, this patent is anticipated to expire on October 10, 2042.
  • Upon issuance, Vanda intends to list this patent in the U.S. Food and Drug Administration publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
  • Vanda acquired rights to U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

Scilex Holding Company Chief Executive Officer and President Issues Letter to Stockholders Highlighting 2023 Accomplishments and Outlook for 2024

Retrieved on: 
Monday, January 8, 2024
Sciatica, Kidney, Orange Book, Pain management, Food, Migraine, LRP, Pain, FDA, Gout, CMC, Chronic pain, Injection, Patent, NDA, Health, GMP, Neurology, PALO, Medicare, Letter, PDL, Observation, Paracetamol, Growth, Pharmacy, Medicaid, Safety, Patient, MENA, Therapy, Rheumatology, NDS, Creativity, Acute liver failure, Communication, Pharmaceutical industry

PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.

Key Points: 
  • PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.
  • Dear Scilex Holding Company Stockholders,
    I would like to express my deepest gratitude for your unwavering support, patience, and invaluable feedback throughout the transformative year in 2023.
  • As we continue to navigate the complexities of the pharmaceutical landscape, your role as stockholders in this journey is invaluable.
  • Despite the challenges that remain ahead, we are setting ambitious goals for the Company in 2024, including:
    Expected launch of Gloperba®.

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Regeneron Pharmaceuticals, Initiate, Conference, AACR, Orange Book, MAPK, Amgen, IND, B-cell maturation antigen, FDA, EMA, BeiGene, EGFR, MAA, Pain, Multiple myeloma, NDA, BCMA, Therapy, Cancer, Investigational New Drug, Event, First grade, Standard of care, TEAD, Neoplasm, Plantar fibromatosis, European Medicines Agency, RAF, European Hematology Association, CD3, MEK, Webcast, NRAS, RAS, Patient, Panitumumab, Pharmaceutical industry

Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

Key Points: 
  • Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.
  • These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
  • Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor, in Hippo mutant solid tumors in the first half of 2024.
  • A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

Sterne Kessler Secures Non-Infringement Win for Teva Pharmaceuticals

Retrieved on: 
Friday, January 5, 2024
Orange Book, Teva, Syndrome, FDA, The Orange Book, Therapy, Cushing's syndrome, Mifepristone, Type, Corcept Therapeutics, Teva Pharmaceuticals, Patient, Prediabetes, Generic drug

WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.

Key Points: 
  • WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.
  • On December 29, 2023, the district court held that Teva does not infringe the two patents asserted at trial, finding that Corcept had failed to show that direct infringement is likely or that Teva's label would induce infringement.
  • Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products.
  • Corcept Therapeutics, Inc., the holder of the Korlym NDA, filed a Hatch-Waxman lawsuit against Teva alleging infringement of two patents listed in the Orange Book for Korlym.

Cosette Pharmaceuticals Acquires Vyleesi® (Bremelanotide Injection) from Palatin Technologies Inc.

Retrieved on: 
Wednesday, January 3, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, Patient, Orange Book, HSDD, Multimedia, Woman, Acquisition, Medication, Education, Bremelanotide, PTN, Female, Urology

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 Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.

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 Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.
  • Palatin and Cosette will ensure continued patient and healthcare professional access to Vyleesi® throughout the transition period.
  • Cosette offers patients the ability to connect with a physician through a telemedicine option.
  • Patients and providers can learn more about HSDD and Vyleesi®, including Important Safety Information, at www.vyleesi.com .