Drug Price Competition and Patent Term Restoration Act

Liquidia Announces the Publication of Long-Term Clinical Data from Completed INSPIRE Study in the Journal Pulmonary Circulation

Retrieved on: 
Monday, August 1, 2022
INSPIRE, International Society, GLOBE, Quality of life, Drug Price Competition and Patent Term Restoration Act, United States v. United States District Court, New Drug Application, Hypertensive emergency, Functional, Incidence, United Therapeutics, American Thoracic Society, Adult, Safety, NYHA, NASDAQ, Conference, Pulmonary Circulation, Month, Drug, International Conference on Afghanistan, London (2010), US Foods, FDA, BNP, AES, Patient, Pulmonary hypertension, District court, LLC, Șaeș, II, N-terminal prohormone of brain natriuretic peptide, Pharmaceutical industry, Health insurance, Birth control, Transition

MORRISVILLE, N.C., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today the publication of clinical data from the completed INSPIRE study evaluating YUTREPIA (treprostinil) inhalation powder, formerly known as LIQ861, in patients with pulmonary arterial hypertension (PAH) in the journal Pulmonary Circulation.

Key Points: 
  • MORRISVILLE, N.C., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today the publication of clinical data from the completed INSPIRE study evaluating YUTREPIA (treprostinil) inhalation powder, formerly known as LIQ861, in patients with pulmonary arterial hypertension (PAH) in the journal Pulmonary Circulation.
  • This publication reports clinical outcomes of PAH patients treated with YUTREPIA who were nave to prostacyclin therapy (Nave patients) or transitioning from nebulized Tyvaso (Transition patients).
  • The pivotal, open label INSPIRE study enrolled 121 adult PAH patients nave to prostacyclin (n=66, Naive) and patients who transitioned from nebulized Tyvaso(n=55, Transition).
  • A total of 69 patients completed at least 12 months of treatment in the INSPIRE study.

Neuvivo Adds Former FDA Chief Counsel Peter Barton Hutt as Advisor

Retrieved on: 
Monday, June 20, 2022
Covington & Burling, Doctor of Philosophy, President's Council of Advisors on Science and Technology, Office of Technology Assessment, China Biologic Products, FDA, Safety, PALO, Orphan Drug Act of 1983, National Academy of Medicine, CEO, Technology assessment, BPS Barbara Wilson Lifetime Achievement Award, Foundation for Biomedical Research, Adoption, Technology, Research, List of lifetime achievement awards, Foundation, Congress, Harvard Law School, Neurodegeneration, PDUFA, National Committee, Prognosis, Policy, Safe Medical Device Amendments of 1990, Senate, Legislation, House, Patient, Biomedical Research, 21st Century Cures Act, Approval, Drug Price Competition and Patent Term Restoration Act, Food and Drug Administration, AIDS, ALS, National academy, Drug, Pharmaceutical industry, Cancer, Science, Food

PALO ALTO, Calif., June 20, 2022 /PRNewswire/ -- Neuvivo, a private late-clinical stage company developing an effective treatment for ALS and other neurodegenerative diseases, today announced it has added Peter Barton Hutt as advisor.

Key Points: 
  • PALO ALTO, Calif., June 20, 2022 /PRNewswire/ -- Neuvivo, a private late-clinical stage company developing an effective treatment for ALS and other neurodegenerative diseases, today announced it has added Peter Barton Hutt as advisor.
  • Peter is senior counsel in the Washington, DC law firm of Covington & Burling LLP, specializing in Food and Drug Law.
  • Notably while at the agency, he wrote the proposed procedural regulations that govern all FDA administrative actions to this day.
  • "I am delighted to join Neuvivo as an advisor and work with the company to deliver a new, effective treatment for people living with ALS," said Peter Barton Hutt.

Neal Gerber Eisenberg Augments Intellectual Property Group with Veteran Partner Jeffrey Ward

Retrieved on: 
Wednesday, January 12, 2022
Legal, Professional Services, Champaign County, Illinois, Lawyer, Jazz Photo Corp. v. United States International Trade Commission, Ward, NGE, Biotechnology, University of Illinois College of Law, United States International Trade Commission, Drug Price Competition and Patent Term Restoration Act, Intellectual Property Law Certification, List, Merchant, Neal, Chemical engineering, Solution, Intellectual property, Illinois College, United States Court of Appeals for the Federal Circuit, Patent, Law, FDA, Steven Naifeh, University, Pharmaceutical industry

Neal Gerber Eisenberg is pleased to announce the addition of Jeffrey S. Ward as a partner in the Intellectual Property practice group.

Key Points: 
  • Neal Gerber Eisenberg is pleased to announce the addition of Jeffrey S. Ward as a partner in the Intellectual Property practice group.
  • I am excited to welcome Jeff to the firms intellectual property practice, said Robert Gerber, Managing Partner of Neal Gerber Eisenberg.
  • Jeffs counseling and litigation experience will be a great advantage to our IP clients, said Thomas McDonough, co-chair of the firm's Intellectual Property practice group.
  • Neal Gerber Eisenberg is a leading law firm dedicated to handling sophisticated matters for entrepreneurs, public companies, and private businesses and their owners.

Wolf Greenfield Promotes Six Attorneys in 2022

Retrieved on: 
Tuesday, January 4, 2022
Legal, Professional Services, AIPLA, Engineering, Artificial intelligence, Invention, United States Customs District of New Bedford, Jazz Photo Corp. v. United States International Trade Commission, Doctor of Philosophy, ITC, Review, Software, Topical steroid withdrawal, MS, Drug Price Competition and Patent Term Restoration Act, Science, Libby, PTAB, Greater Boston, Greenfield, IP, Patent Trial and Appeal Board, MD, Diabetes, United States International Trade Commission, Culture, Semiconductor, Partner (business rank), Patent, U.S. Customs and Border Protection, Come, Orange Book, Lawyer, Physics, Light, United States Patent and Trademark Office, Pharmaceutical industry

Wolf Greenfield is pleased to announce the promotion of two attorneys to the position of shareholder and four attorneys to the position of counsel, effective January 1, 2022.

Key Points: 
  • Wolf Greenfield is pleased to announce the promotion of two attorneys to the position of shareholder and four attorneys to the position of counsel, effective January 1, 2022.
  • After another strong year for the firm, it is exciting to announce these well-deserved promotions, said Ed Gates, Wolf Greenfields President and Managing Partner.
  • Each of these attorneys embody Wolf Greenfields culture and values, and they exude passion toward their work and the clients they serve.
  • Wolf Greenfield is among the 10 largest law firms in the country devoted exclusively to intellectual property law.

FDA Grants Tentative Approval for Liquidia’s YUTREPIA™ (Treprostinil) Inhalation Powder

Retrieved on: 
Monday, November 8, 2021
NDA, USPTO, Safety, Drug Price Competition and Patent Term Restoration Act, Industry, Private Securities Litigation Reform Act, Therapy, PAH, New York Heart Association Functional Classification, INSPIRE, NASDAQ, EST, District court, Functional, Pharmacology, Food, Coronavirus, Trial of the century, Goal, Exercise, COVID-19, Treprostinil, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Drug, Douglas v. U.S. District Court ex rel Talk America, Delaware, LLC, Conference call, NYHA, GLOBE, Environment, Event, Hypertensive emergency, SEC, Webcast, Review, Lung, Pulmonary hypertension, Patent, Patient, District, FDA, PTAB, Adult, Pharmaceutical industry

Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States.

Key Points: 
  • Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States.
  • In 2020, United Therapeutics reported that its nebulized formulation of treprostinil indicated for PAH achieved sales of more than $480 million.
  • Liquidia will host a webcast and conference call Monday, November 8, 2021, at 9:00 a.m. EST to discuss this regulatory update for YUTREPIA (treprostinil) inhalation powder.
  • Liquidia Technologies has developed YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH).

Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®

Retrieved on: 
Monday, October 18, 2021
AMAG Pharmaceuticals, XR, Industry, Private Securities Litigation Reform Act, Cirrhosis, Contributor License Agreement, Testosterone, Trial of the century, NDA, Adult, Hypogonadism, Birth, SEC, Ferring Pharmaceuticals, License, Teva, FDA, Multimedia, TRT, NASH, Drug Price Competition and Patent Term Restoration Act, Exercise, Pfizer, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Hydroxyprogesterone caproate, AMAG, Form 10-K, Company, Preterm birth, Form 8-K, Antares, Hypogonadotropic hypogonadism, NASDAQ, Therapy, Methotrexate, Pharmaceutical industry, Generic drug

Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO.

Key Points: 
  • Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO.
  • Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S.
  • Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR.
  • Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Padagis Confirms First-to-File Patent Challenge For Generic Version Of Eucrisa®

Retrieved on: 
Tuesday, September 28, 2021
Atopic dermatitis, Patent, Patient, District court, Drug Price Competition and Patent Term Restoration Act, Paragraph, Orange Book, IQVIA, ANDA, Douglas v. U.S. District Court ex rel Talk America, Generic drug

Eucrisa (crisaborole ointment 2%) is indicated for the treatment of mild-to-moderate eczema (atopic dermatitis) in adults and children 3 months of age and older.

Key Points: 
  • Eucrisa (crisaborole ointment 2%) is indicated for the treatment of mild-to-moderate eczema (atopic dermatitis) in adults and children 3 months of age and older.
  • Annual market sales for the 12 months ending June 2021 were approximately $258 million as measured by IQVIA.
  • Padagis Chief Executive Officer, Sharon Kochan, stated, "This is our third confirmed first-to-file ANDA filing in 2021.
  • Padagis is dedicated to improving the well-being of as many patients and consumers as possible by developing, manufacturing and distributing high quality, affordable specialized healthcare products.

Palatin Announces U.S. Patent Term Extension for Vyleesi® (bremelanotide injection)

Retrieved on: 
Tuesday, May 4, 2021
Intellectual property law, Patent law, Term of patent in the United States, United States patent law, Intellectual property organizations, Term of patent, International Searching and Preliminary Examining Authorities, Patent offices, Bremelanotide, Drug Price Competition and Patent Term Restoration Act, United States Patent and Trademark Office, Patent

For more information on Vyleesi, go to www.vyleesi.com .\nThe patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years as compensation for patent term lost during drug development and the FDA regulatory review process.

Key Points: 
  • For more information on Vyleesi, go to www.vyleesi.com .\nThe patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years as compensation for patent term lost during drug development and the FDA regulatory review process.
  • An interim extension for a period of one year from the original expiration date of both patents of June 25, 2020, was granted by the USPTO in May 2020.
  • In the Notices of Final Determination issued by the USPTO, the maximum allowable five-year extension was granted.\nPalatin has filed an Election to extend the patent term of U.S. patent 6,794,489.
  • Palatin is not responsible for updating for events that occur after the date of this press release.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/palatin-announces-us-patent-term...\n'

The FDA Drug Approval Process - Two Day Event: London, United Kingdom - September 21-22, 2020 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 17, 2020
Health, Pharmaceutical, Health, Articles, Food and Drug Administration, Drug Price Competition and Patent Term Restoration Act, Drug Master File

The "The FDA Drug Approval Process" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The FDA Drug Approval Process" conference has been added to ResearchAndMarkets.com's offering.
  • This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.
  • The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region.
  • Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)

Pharmaceutical Patent Litigation Increases Nearly 30 Percent in 2017: Lex Machina Releases Fourth Hatch-Waxman/ANDA Litigation Report

Retrieved on: 
Thursday, May 3, 2018
Health, Food and Drug Administration, United States patent law, Drug Price Competition and Patent Term Restoration Act, Lex Machina, Abbreviated New Drug Application, Patent Trial and Appeal Board, PTAB, Waxman, Approved Drug Products with Therapeutic Equivalence Evaluations, Law

MENLO PARK, Calif., May 3, 2018 /PRNewswire/ -- Lex Machina , a LexisNexis company and creator of the award-winning Legal Analytics platform, today announced the release of its fourth annual Hatch-Waxman/ANDA Litigation Report.

Key Points: 
  • MENLO PARK, Calif., May 3, 2018 /PRNewswire/ -- Lex Machina , a LexisNexis company and creator of the award-winning Legal Analytics platform, today announced the release of its fourth annual Hatch-Waxman/ANDA Litigation Report.
  • The report focuses on FDA Paragraph IV pharmaceutical patent litigation related to Abbreviated New Drug Applications (ANDAs) filed in U.S. district courts under the Hatch-Waxman Act, and Patent Trial and Appeal Board (PTAB) cases involving FDA Orange Book patents.
  • During this time, 741 ANDA cases and 196 PTAB pharmaceutical petitions were filed, while 843 ANDA cases and 246 PTAB pharmaceutical trials were completed.
  • Delivered as Software-as a-Service, Lex Machina provides strategic insights on judges, lawyers, parties, and more, mined from millions of pages of legal information.