Orange Book

Terran Biosciences Granted US Patent for the World’s First New Forms of MDMA, Potentially Clearing the Path to a Future 505(b)(2) Approval

Retrieved on: 
Wednesday, April 17, 2024
Software, Research, Radiology, Pharmaceutical, Mental Health, Technology, Hospitals, Clinical Trials, Science, Neurology, Biotechnology, FDA, Health, Salt, Post-traumatic stress disorder, Safety, Terran, PTSD, Orange Book, MD, Doctor of Philosophy, Therapy, MDMA, Patent, Patient, GMP, Merck, Pharmaceutical industry

Terran now holds the only granted composition of matter patent on a new form of MDMA.

Key Points: 
  • Terran now holds the only granted composition of matter patent on a new form of MDMA.
  • MDMA HCl has been submitted to the FDA for approval on the 505(b)(1) path and is currently undergoing FDA review, with a decision expected by August this year.
  • If the FDA approves MDMA HCl, Terran plans to use its new form of MDMA hemifumarate to pursue a rapid 505(b)(2) FDA approval pathway.
  • MDMA-assisted psychotherapy could revolutionize the treatment of PTSD and Terran will ensure that affordable MDMA is not delayed.”

Evofem Strengthens Phexxi Intellectual Property with New Composition of Matter Patent From USPTO

Retrieved on: 
Thursday, April 18, 2024
FDA, Patient, Lactic acid, Orange, Pregnancy, Woman, OTCQB, Hormone, Orange Book, Citric acid, Birth, Patent, SAN, Birth control

SAN DIEGO, April 18, 2024 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/823,020 entitled, "Compositions and Methods for Enhancing the Efficacy of Contraceptive Microbicides." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

Key Points: 
  • This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • The allowed claims cover methods of contraception with a composition that encompasses Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel.
  • The patent, when issued, will be Evofem's fifth patent for Phexxi in the United States.
  • "This patent allowance attests to the innovation Phexxi brings to contraception and a woman's ability to protect herself from unintended pregnancy with no hormones."

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.

Evoke Pharma Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Research, Certification, Quarter, Prevalence, Teva Pharmaceuticals, Gastrointestinal disease, Partnership, ACG, Metoclopramide, Patient, Pharmacy, Gastroparesis, Health care, Holocene, Prescription, Orange Book, Marketing, Gastroenterology, Woman, DDW, PBM, Hospital, Pharmaceutical industry

SOLANA BEACH, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the fourth quarter and full year ended December 31, 2023, and recent corporate developments.

Key Points: 
  • Our commercial team’s dedicated efforts yielded a 107% increase in year-over-year revenue,” stated Dave Gonyer, R.Ph., CEO of Evoke Pharma.
  • Research and development expenses totaled approximately $23,000 for the fourth quarter of 2023 compared with $27,000 for the fourth quarter of 2022.
  • For the fourth quarter of 2023 selling, general and administrative (SG&A) expenses were approximately $3.5 million compared with $2.3 million for the fourth quarter of 2022.
  • Total operating expenses for the fourth quarter of 2023 were approximately $3.6 million compared with $2.3 million for the same period of 2022.

Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Administration, Growth, Nitisinone, Patent, Patient, NDA, Orange Book, Trial of the century, Diurnal, Carglumic acid, Research and development, FDA, Endocrinology, Physician, Pharmaceutical industry

Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.

Key Points: 
  • Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.
  • Eton generated $0.4 million of operating cash during the fourth quarter of 2023, with total cash and cash equivalents of $21.4 million as of December 31, 2023.
  • Total net revenues were $7.3 million for the fourth quarter of 2023, compared to $8.5 million for the fourth quarter of 2022.
  • As previously announced, Eton Pharmaceuticals will host its fourth quarter 2023 conference call as follows:

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.

WIT Legal Releases New Report on 2023 Activities and Trends in Hatch-Waxman Litigation

Retrieved on: 
Wednesday, March 20, 2024
Orange Book, New Drug Application, Orange, Patent, Abbreviated New Drug Application, WIT, NDA, Johnson & Johnson, Generic drug

NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.

Key Points: 
  • NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.
  • The new WIT report examines Abbreviated New Drug Application (ANDA) cases and the Orange Book-listed products at issue.
  • "Our intent is to provide the most comprehensive review of true ANDA litigation available," said Michael Connelly, WIT President.
  • Additionally, the report goes beyond the specific companies involved to provide insight into the corporate families driving ANDA litigation to highlight potential market dynamics and litigation trends.

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.