Orange Book

FTC Files Amicus Brief in Asthma Inhaler Patent Dispute

Retrieved on: 
Tuesday, April 2, 2024
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Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products, according to the FTC’s brief.

Key Points: 
  • Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products, according to the FTC’s brief.
  • The FTC’s amicus brief relates to a case brought by Teva against drugmaker Amneal after Amneal sought FDA approval to bring a generic version of asthma inhaler ProAir HFA to market.
  • Teva sued Amneal for patent infringement, arguing that Amneal’s patents infringe on Teva’s ProAir HFA patents.
  • The FTC’s amicus brief was filed in the U.S. District Court for the District of New Jersey.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Eton Pharmaceuticals Awarded U.S. Patent for Proprietary Hydrocortisone Oral Liquid Formulation

Retrieved on: 
Wednesday, February 21, 2024
Orange Book, Patent

DEER PARK, Ill., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (“USPTO”) has granted the Company’s U.S. Patent Application No.

Key Points: 
  • DEER PARK, Ill., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (“USPTO”) has granted the Company’s U.S. Patent Application No.
  • 18/113,458, which covers the Company’s ET-400 product candidate’s proprietary formulation of oral liquid hydrocortisone.
  • The patent has an expiration in 2043 and is expected to be listed in the FDA’s Orange Book upon the product’s approval.
  • The Company has additional patent applications related to the product under review with the USPTO.

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

Retrieved on: 
Thursday, February 15, 2024
EVS, Orange Book, Senior, FTC, Food and Drug Administration, Artificial intelligence, AI, FDA, Food, Growth, CPSC, Virtual reality, Federal Trade Commission, The Orange Book, Approved drug, Mocra, USDA, Medical device

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
District court, Orange Book, Manager, Interim, The Orange Book, Patent, Generic drug

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®.