The Orange Book

BioXcel Therapeutics Reports First Quarter 2024 Financial Results

Retrieved on: 
Thursday, May 9, 2024
FDA, The Orange Book, Tachyphylaxis, Patient, Research and development, Safety, Agitation, Conference call, Research, Orange Book, Conference, Administration, Intelligence, Schizophrenia, Patent, Acquisition, DSM-IV codes, Intellectual property, Therapy, Pharmaceutical industry

NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter of 2024.

Key Points: 
  • ET today
    NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter of 2024.
  • Net Loss: BioXcel Therapeutics had a net loss of $26.8 million for the first quarter of 2024, compared to a net loss of $52.8 million for the same period in 2023.
  • BioXcel Therapeutics will host a conference call and webcast today, May 9, 2024, at 8:00 a.m.
  • ET to discuss its first quarter 2024 financial results.

Verrica Pharmaceuticals Announces that YCANTH™ Receives New Chemical Entity Status and Orange Book Listing from the FDA

Retrieved on: 
Tuesday, March 26, 2024
The Orange Book, NCE, Orange Book, Dermatology, Skin, Patent, Therapy, FDA, Approved drug, Food, Pharmaceutical industry

WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.

Key Points: 
  • The Company’s U.S. patents and pending patent applications related to YCANTH™ are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension
    WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.
  • “We could not be more pleased to announce YCANTH™ has been granted NCE Status by the FDA,” said Ted White, Verrica’s President and Chief Executive Officer.
  • “Today’s announcement represents the continued execution of our Company’s comprehensive intellectual property strategy to maximize the patent and regulatory protections surrounding YCANTH™ and further underscores the product’s innovation and intrinsic value in the dermatology market.
  • While NCE status will provide YCANTH™ with a minimum of five years of protection, we anticipate our full patent portfolio to provide protection from generic competition for the next decade and potentially beyond.”
    Formally described as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is an FDA publication that provides a list of drugs approved as safe and effective and also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data.1 The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled.

BioXcel Therapeutics Announces European Patent Office’s Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine

Retrieved on: 
Friday, March 15, 2024
The Orange Book, Agitation, Patent, Intelligence, Patient, Tablet, Heel, EPO, Orange Book, Therapy, European Patent Convention, Dexmedetomidine, FDA, Dementia, Pharmaceutical industry

The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.

Key Points: 
  • The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.
  • The patent encompasses a broad range of dosage forms, including films such as BXCL501 (sublingual dexmedetomidine), wafers, and tablets, at dexmedetomidine doses ranging from 3 mcg to 100 mcg.
  • 17/496,470 with claims pertaining to methods of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.
  • The patent, when issued, is expected to have an expiration date of July 17, 2040, subject to patent term adjustment, patent term extension, and terminal disclaimers.

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 12, 2024
The Orange Book, Patent Cooperation Treaty, Agitation, Administration, Conference call, Type, PCT, Conference, Database, Schizophrenia, Intelligence, Caregiver, Webcast, Patient, DSM-IV codes, Neuroscience, Fast Track, Food and Drug Administration, CMC, Wind, Orange Book, SCNC, Positive, Microsatellite instability, Dexmedetomidine, Clinical trial, Therapy, Safety, Patent, Research and development, Collection, FDA, Approved drug, Dementia, CAD, Food, Pharmaceutical industry

NEW HAVEN, Conn., March 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • In addition, the Company reported its financial results for the fourth quarter and full year 2023.
  • Net Revenue: Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022.
  • Net Loss: BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022.
  • ET to provide an update on recent operational highlights and to discuss its fourth quarter and full year 2023 financial results.

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

Retrieved on: 
Wednesday, April 3, 2024
Legal, Biotechnology, Pharmaceutical, Public Relations, Investor Relations, Health, FDA, Communications, Professional Services, The Orange Book, Drug discovery, Carcinoma, Patent, District court, Mitomycins, Orange Book, Food, Generic drug

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).
  • Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution.
  • JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.
  • “UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen.

FTC Files Amicus Brief in Asthma Inhaler Patent Dispute

Retrieved on: 
Tuesday, April 2, 2024
The Orange Book, GSK plc, AstraZeneca, District court, Boehringer Ingelheim, Social media, Salbutamol, Policy, News, Blog, Motion, Judgement, Orange Book, Commission, Patent, FDA, Federal Trade Commission, Food, FTC

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.

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.

BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine

Retrieved on: 
Monday, February 5, 2024
Dexmedetomidine, Intelligence, Agitation, Patent, The Orange Book, Schizophrenia, Patient, PTE, Therapy, PTA, IP, Tablet, DSM-IV codes, Bipolar disorder, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers. The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (“PTA”), patent term extension (“PTE”), and terminal disclaimers.

Key Points: 
  • 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.
  • The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers.
  • The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (“PTA”), patent term extension (“PTE”), and terminal disclaimers.
  • The Company also announced that it has received an issue notification from the USPTO for U.S. Patent Application No.