Orange Book

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.

CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath

Retrieved on: 
Wednesday, August 30, 2023
Infection, Patent, Intellectual property, The Orange Book, Abbreviated New Drug Application, New Drug Application, NDA, New chemical entity, Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, FDA, United States patent law, Pharmaceutical industry

11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.

Key Points: 
  • 11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.
  • This newly issued U.S. Patent, for which CorMedix previously announced the allowance of patent claims, reflects the unique and proprietary nature of DefenCath®, and will extend the Company’s current intellectual property protection with an expiration date of April 15, 2042.
  • The newly issued patent claims supplement CorMedix’s existing licensed U.S. Patent No.
  • 7,696,182, and provide an additional layer of patent protection for DefenCath.

Alkermes Announces Settlement With Teva Related to VIVITROL® Patent Litigation

Retrieved on: 
Wednesday, August 30, 2023
1836 U.S. Patent Office fire, Patent, Orange, Teva, Justice, United States Department of Justice, Naltrexone, Federal Trade Commission, ALKS, Food and Drug Administration, Orange Book, Injunction, VIVITROL, District court, Alkermes, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Court, Douglas v. U.S. District Court ex rel Talk America, Generic drug

DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension). Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.

Key Points: 
  • DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension).
  • Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No.
  • 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.
  • The company and Teva will submit the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice.

Alkermes Announces Settlement With Teva Related to VIVITROL® Patent Litigation

Retrieved on: 
Wednesday, August 30, 2023
1836 U.S. Patent Office fire, Patent, Orange, Teva, Justice, United States Department of Justice, Naltrexone, Federal Trade Commission, ALKS, Food and Drug Administration, Orange Book, Injunction, VIVITROL, District court, Alkermes, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Court, Douglas v. U.S. District Court ex rel Talk America, Generic drug

DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension). Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.

Key Points: 
  • DUBLIN, Aug. 30, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension).
  • Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No.
  • 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.
  • The company and Teva will submit the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice.