Orange Book

FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book

Retrieved on: 
Wednesday, January 3, 2024
Federal Trade Commission, Policy, Food, Orange Book, AstraZeneca, FDA, Blog, The Orange Book, NDA, Boehringer Ingelheim, News, Asthma, New Drug Application, Patent, FTC, Social media, Investment, Amneal Pharmaceuticals, Commission, Epinephrine autoinjector, AbbVie, Delays

“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.

Key Points: 
  • “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.
  • “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens.
  • Last month, the FTC issued a policy statement that warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book.
  • Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law.

FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings

Retrieved on: 
Wednesday, January 3, 2024
Federal Trade Commission, Policy, Sanofi, Orange Book, Food, Insulin glargine, FDA, Blog, Insulin, Diabetes, Orange, The Orange Book, News, Patent, FTC, Social media, Patient, Commission, District court, Pharmaceutical industry

Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process.

Key Points: 
  • Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process.
  • In September, the FTC issued a policy statement which warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book.
  • The Commission’s statement warned that improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high.
  • In November, the FTC sent letters to 10 drug manufacturers notifying them of more than 100 improperly listed Orange Book patents.

Scilex Holding Company announces successful FDA audit of enhanced ZTlido® manufacturing facility in Japan

Retrieved on: 
Thursday, November 30, 2023
Orange Book, Food, Neck pain, FDA, Pain, Chronic pain, Patent, The Orange Book, GMP, PALO, Lidocaine, Oishi, Pharmaceutical industry

Enhanced 250kg manufacturing facility assures increased capacity to meet rapidly growing ZTlido® demand.

Key Points: 
  • Enhanced 250kg manufacturing facility assures increased capacity to meet rapidly growing ZTlido® demand.
  • This successful audit allows Scilex to continue commercializing ZTlido® product manufactured at 250kg scale at Oishi’s facility.
  • This facility is also the manufacturing site for SP-103 (lidocaine topical system, atriple strength formulation of ZTlido®) that recently completed trials in acute back pain and neck pain.
  • “This successful FDA GMP inspection highlights the GMP and quality assurance of our partner Oishi’s manufacturing facility in Japan, which is essential as we scale the commercial production of ZTlido®,” said Jaisim Shah, Chief Executive Officer and President of Scilex.

Evoke Pharma Announces FDA Orange Book Listing of New GIMOTI Patent

Retrieved on: 
Monday, November 27, 2023
Orange Book, Food, Collection, FDA, The Orange Book, Metoclopramide, Patent, IP, Gastroparesis, Pharmaceutical industry

11,813,231 is 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”.

Key Points: 
  • 11,813,231 is 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”.
  • The patent titled “Nasal Formulations of Metoclopramide” covers a collection of nasal solutions of metoclopramide and its characteristics when formulated.
  • This new patent is now listed in the FDA’s Orange Book and carries a patent term to 2029.
  • The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior three listed patents.

BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Webcast, Schizophrenia, DSM-IV codes, Safety, Therapy, Ageing, Conference call, Qatar Investment Authority, Investment, Administration, Patient, Research, Orange Book, FDA, Artificial intelligence, Prostate cancer, Documentation, Agitation, Dementia, Partnership, Oaktree Capital Management, Adenocarcinoma, Shanda, R, Research and development, Medicare, Government, Fine chemical, Pharmaceutical industry, Health insurance, Conference

In addition, the Company provided an update on strategic financing activities that would enable greater operational flexibility and reported its financial results for the third quarter ended Sept. 30, 2023.

Key Points: 
  • In addition, the Company provided an update on strategic financing activities that would enable greater operational flexibility and reported its financial results for the third quarter ended Sept. 30, 2023.
  • Company aligned with FDA’s recommendation to conduct additional Phase 3 trial of BXCL501 to evaluate safety and collect additional efficacy data in at-home setting.
  • Completed meeting with FDA on November 8, 2023; meeting minutes expected by the first half of December 2023.
  • ET to provide an update on recent operational highlights and to discuss its third quarter 2023 financial results.

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023
Capsule, Sustainability, Budesonide, CALT, CET, Orange Book, Immunoglobulin A, Person, Patent, IgA nephropathy, Medical device

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023
Capsule, Sustainability, Budesonide, CALT, CET, Orange Book, Immunoglobulin A, Person, Patent, IgA nephropathy, Medical device

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.

NEURELIS SECURES NEW ORANGE BOOK LISTED U.S. PATENT FOR VALTOCO® (DIAZEPAM NASAL SPRAY) CIV

Retrieved on: 
Monday, November 27, 2023
SAN, Food, Disease, Patient, Diazepam, Orange Book, FDA, Therapy, Epilepsy, Patent, Benzyl alcohol, Tocotrienol, The Orange Book, Pharmaceutical industry, Gustav Neuring

SAN DIEGO, Nov. 27, 2023 /PRNewswire/ -- Neurelis, Inc., a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, announced that it has secured the issuance of United States Patent No. 11,793,786 (the '786 Patent). The '786 Patent covers VALTOCO® and other pharmaceutical solutions for nasal administration consisting of diazepam or a pharmaceutically acceptable salt thereof in combination with specific ranges of one or more natural or synthetic tocopherols or tocotrienols, benzyl alcohol, and n-dodecyl beta-D-maltoside.

Key Points: 
  • 11,793,786 (the '786 Patent).
  • The '786 Patent is listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, as it relates to VALTOCO®, and is solely owned by Neurelis.
  • "We will continue to expand our intellectual property, memorializing the scientific innovation that drives Neurelis' commitment to improving patient outcomes.
  • The '786 Patent, with an expiry date of March 2029, joins five other Orange Book listed patents that currently provide exclusivity to the VALTOCO franchise through 2029.

Catalyst Pharmaceuticals Reports Strong Third Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Yoy, PDUFA, Catalysis, Intangibles, Anticipation, GAAP, Acquisition, Orange Book, Development, Vamorolone, Bank statement, PMDA, Growth, Amifampridine, COVID-19, Duchenne muscular dystrophy, Webcast, Intangible asset, Lambert–Eaton myasthenic syndrome, IPR, NDA, Epilepsy, Accounting, Administration, Cash, YTD, Bank, Pharmaceutical industry, Beauty salon, Video game, Cryptocurrency

These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance.

Key Points: 
  • These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance.
  • Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting.
  • Intangible assets acquired after the third quarter of 2022 relate to the FYCOMPA rights acquired in the first quarter of 2023.
  • The Company will host a conference call and webcast on Thursday, November 9, 2023, at 8:30 AM ET to discuss the financial results and provide a business update.

Liquidia Corporation Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Type, United Therapeutics, United States District Court for the Eastern District of Texas, FDA, Research, Sale, New Drug Application, Drug Price Competition and Patent Term Restoration Act, IND, PDUFA, Food, Patent, CAFC, Silicon, PRINT, Prescription Drug User Fee Act, Security, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Certification, Peru–United States Trade Promotion Agreement, Orthostatic hypertension, The Orange Book, United States Court of Appeals for the Federal Circuit, Orange Book, Promotion, UTHR, Pulmonary hypertension, District court, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Patent Trial and Appeal Board, Douglas v. U.S. District Court ex rel Talk America, PAH, Lender option borrower option, NDA, PTAB, Patient, Treprostinil, Pharmaceutical industry, Cryptocurrency

Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023

Key Points: 
  • Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023
    PDUFA goal date to add PH-ILD indication to YUTREPIA label is January 24, 2024
    MORRISVILLE, N.C., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the third quarter ended September 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Cash totaled $76.2 million as of September 30, 2023, compared to $93.3 million as of December 31, 2022.
  • Total other expense, net was $0.9 million for the three months ended September 30, 2023, compared with $0.3 million for the three months ended September 30, 2022.