Orange Book

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.

Catalyst Pharmaceuticals Receives Two New U.S. Patent Allowances For FIRDAPSE®

Retrieved on: 
Thursday, November 2, 2023
CORAL, Fasting, Patent, Rare, United States Patent and Trademark Office, Orange Book, Catalyst Pharmaceuticals, Amifampridine, Approved Drug Products with Therapeutic Equivalence Evaluations, Lambert–Eaton myasthenic syndrome, Tablet, Patient, NAT2, Pharmaceutical industry, Catalysis

FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.

Key Points: 
  • FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.
  • "We are very pleased to receive these patent notifications from the USPTO.
  • "These patent allowances strengthen our cumulative understanding of the uniqueness of FIRDAPSE and bolster its strong intellectual property estate offering enhanced patent protection," stated Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer of Catalyst.
  • Preparations are already in motion to include these additional FIRDAPSE patents in the FDA Orange Book post-grant, bringing the total listed patent count to eight."

Eagle Pharmaceuticals Granted Patent for PEMFEXY®

Retrieved on: 
Tuesday, October 24, 2023
Pemetrexed, FDA, Patent, 27th Construction Company (U.S. Army Air Service), Food, Certification, The Orange Book, Orange Book, Paragraph, CMS, Pharmaceutical industry, Eagle

WOODCLIFF LAKE, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No.

Key Points: 
  • WOODCLIFF LAKE, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No.
  • 11,793,813 (“the ‘813 patent”) entitled “Pemetrexed Formulations.” Eagle has submitted the patent for listing in the U.S. Food and Drug Administration’s Orange Book.1 The ‘813 patent is directed to pemetrexed formulations, including the FDA-approved commercial formulation of PEMFEXY®.
  • This is the second patent to be listed in the Orange Book for PEMFEXY, and to date Eagle has not received any notice of a Paragraph IV certification for an application referencing PEMFEXY.
  • “The issuance of this patent is meaningful, as we continue to vigorously protect the commercial success of PEMFEXY and to add to the overall strength of our patent portfolio.

BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs and Expansion of IP Portfolio for IGALMI™ (dexmedetomidine) Sublingual Film

Retrieved on: 
Wednesday, October 4, 2023
Patent, The Orange Book, Dexmedetomidine, Aes, Part, II, Agitation, Orange Book, Incidence, Dementia, Shanda, PEC, Live, Patient, Approved Drug Products with Therapeutic Equivalence Evaluations, Bipolar, Artificial intelligence, Security (finance), FDA, Therapy, Noa Pothoven, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, DSM-IV codes, Pharmaceutical industry, HAVEN, Schizophrenia

NEW HAVEN, Conn., Oct. 04, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience, today provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI™ (dexmedetomidine) sublingual film. These developments include meetings scheduled with the U.S. Food and Drug Administration (FDA) to discuss the TRANQUILITY and SERENITY III clinical programs and the receipt of two Notices of Allowance (NOAs) from the U.S. Patent and Trademark Office to extend method of use patent protection for sublingual dexmedetomidine.

Key Points: 
  • “The meetings with the FDA are critical components of our business strategy.
  • The briefing book submitted to FDA for the meeting includes results from 11 double-blind, placebo-controlled Phase 2 and 3 clinical trials evaluating the safety and efficacy of BXCL501.
  • The Company now has four U.S. patents claiming formulations of dexmedetomidine with exclusivity until 2039 currently listed in the Orange Book.
  • These patents further broaden the scope of intellectual property estate for IGALMI™ and for future potential indications.

Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire

Retrieved on: 
Wednesday, September 27, 2023
Abbreviated New Drug Application, Lactic acid, Paragraph, OTCQB, Certification, Orange Book, SAN, Citric acid, ANDA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Approved Drug Products with Therapeutic Equivalence Evaluations, Generic drug, Lactic acid/citric acid/potassium bitartrate

SAN DIEGO, Sept. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that Padagis Israel Pharmaceuticals Ltd. (Padagis) has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application (ANDA) for a generic version of Phexxi® (lactic acid, citric acid and potassium bitartrate) and has instead converted to a Paragraph III certification. With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA. The latest-expiring Phexxi patents do not expire until 2033.

Key Points: 
  • With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA.
  • Padagis previously submitted its ANDA in April 2023 requesting permission to manufacture and market a generic version of Phexxi.
  • That ANDA contained a Paragraph IV certification, in response to which Evofem initiated patent infringement litigation against Padagis.
  • ' All four patents would need to expire or be deemed invalid or not infringed before a generic version of Phexxi could be marketed.

FTC Announces Tentative Agenda for September 14 Open Meeting

Retrieved on: 
Wednesday, September 27, 2023
Digital media, Advertising, Orange, The Orange Book, Solution, Commission, Policy, Research, Social media, Federal Trade Commission, Orange Book, FTC, Comment, Approved drug, Webcast, Digital, Fraud, News, Food, Approved Drug Products with Therapeutic Equivalence Evaluations, Patent

Today, Federal Trade Commission Chair Lina M. Khan announced that an open meeting of the Commission will be held virtually on Thursday, September 14, 2023.

Key Points: 
  • Today, Federal Trade Commission Chair Lina M. Khan announced that an open meeting of the Commission will be held virtually on Thursday, September 14, 2023.
  • Members of the public must sign up for an opportunity to address the Commission virtually at the September 14 event.
  • A link to the event will be available on the day of the open meeting, shortly before it starts via FTC.gov.
  • Follow the FTC on social media, read our blogs and subscribe to press releases for the latest FTC news and resources.

FTC Issues Policy Statement on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in the Food and Drug Administration’s ‘Orange Book’

Retrieved on: 
Wednesday, September 27, 2023
Orange, The Orange Book, Marketing, Approved Drug Products with Therapeutic Equivalence Evaluations, Catalog, Commission, Policy, Federal Trade Commission Act of 1914, Economy, Federal Trade Commission, Orange Book, Patent, FTC, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, News, Food, Executive order, Pharmaceutical industry, Generic drug, Facebook

The FTC will scrutinize improper Orange Book patent listings as potential unfair methods of competition in violation of Section 5 of the FTC Act.

Key Points: 
  • The FTC will scrutinize improper Orange Book patent listings as potential unfair methods of competition in violation of Section 5 of the FTC Act.
  • “The FTC is making clear that improper Orange Book listings may be an unfair method of competition in violation of the FTC Act.
  • As described in the policy statement, listing certain types of brand drug patents in the Orange Book is a statutory requirement.
  • The policy statement emphasizes that “[p]atents improperly listed in the Orange Book can significantly undermine competition and harm the American public.

FTC Announces Tentative Agenda for September 14 Open Meeting

Retrieved on: 
Wednesday, September 27, 2023
Digital media, Advertising, Orange, The Orange Book, Solution, Commission, Policy, Research, Social media, Federal Trade Commission, Orange Book, FTC, Comment, Approved drug, Webcast, Digital, Fraud, News, Food, Approved Drug Products with Therapeutic Equivalence Evaluations, Patent

Today, Federal Trade Commission Chair Lina M. Khan announced that an open meeting of the Commission will be held virtually on Thursday, September 14, 2023.

Key Points: 
  • Today, Federal Trade Commission Chair Lina M. Khan announced that an open meeting of the Commission will be held virtually on Thursday, September 14, 2023.
  • Members of the public must sign up for an opportunity to address the Commission virtually at the September 14 event.
  • A link to the event will be available on the day of the open meeting, shortly before it starts via FTC.gov.
  • Follow the FTC on social media, read our blogs and subscribe to press releases for the latest FTC news and resources.