Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

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

Retrieved on: 
Tuesday, November 7, 2023
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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.

Vanda Pharmaceuticals Intends to Petition the U.S. Supreme Court in its HETLIOZ® ANDA Litigation

Retrieved on: 
Friday, October 20, 2023
United States Court of Appeals for the Federal Circuit, Patent, Vanda, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Teleflex, Public, Pharmacy, Apotex Inc v Sanofi-Synthelabo Canada Inc, Patient, Generic drug

Vanda's petition seeks to show that the Federal Circuit's approach to obviousness has deviated materially from KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), which trains the obviousness inquiry on whether the claimed innovations "do more than yield a predictable result."

Key Points: 
  • Vanda's petition seeks to show that the Federal Circuit's approach to obviousness has deviated materially from KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), which trains the obviousness inquiry on whether the claimed innovations "do more than yield a predictable result."
  • Vanda believes that the Federal Circuit's approach improperly invalidates critical patent rights, which are necessary to ensure robust pharmaceutical research and development.
  • "Properly calibrated patent protection is essential to pharmaceutical innovation, which is in turn critical for advances in public health.
  • Chief Justice Roberts extended the time for the filing of Vanda's forthcoming petition, which Vanda expects to file by January 12, 2024.

Alkermes Announces Settlement With Teva Related to VIVITROL® Patent Litigation

Retrieved on: 
Wednesday, August 30, 2023
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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.

FDA Approves First Biosimilar to Treat Multiple Sclerosis

Retrieved on: 
Thursday, August 24, 2023
China Biologic Products, Sclerosis, Infection, Vagina, REMS, Hepatotoxicity, Communication, Gastroenteritis, Disease, Risk factor, Central nervous system, Human, Depression, Crohn's disease, Diarrhea, PML, Human polyomavirus 2, Center for Drug Evaluation and Research, Pharmacy, Biosimilar, Disability, Urinary tract infection, Woman, Liver injury, Brain, Inflammation, Multiple sclerosis, Arthralgia, Antibody, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Rash, MS, Pain, Patient, Division, Risk, Anaphylaxis, Autoimmune disease, Viral, Research, FDA, Headache, JC, Death, Immunosuppression, Thrombocytopenia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Vaginitis, Safety, Fatigue, Pharmaceutical industry, Generic drug, Nursing, Natalizumab

SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
  • "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research.
  • This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
  • The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

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

Retrieved on: 
Thursday, August 10, 2023
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MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “This quarter saw Liquidia significantly advance our mission to become the leading inhaled treprostinil provider for pulmonary hypertension patients.
  • Briefing in the appeal should be completed in fourth quarter 2023 and oral arguments will be heard on the next available date in the oral argument calendar, expected to be late fourth quarter 2023 to early 2024.

Exelixis, Inc. Announces Settlement of CABOMETYX® (cabozantinib) Patent Litigation with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc.

Retrieved on: 
Sunday, July 23, 2023
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Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (collectively Teva).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (collectively Teva).
  • This settlement resolves patent litigation brought by Exelixis in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents.
  • Additionally, in accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Exelixis and Teva regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.
  • The Agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

Techdow USA Announces Launch of its Generic Lovenox®, (Enoxaparin Sodium – Preservative Free) in Prefilled Syringes

Retrieved on: 
Thursday, June 8, 2023
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Techdow USA Inc. (“Techdow USA”), a growing market leader and vertically integrated generic injectables company, today announced the launch of its 30mg, 40mg, 60mg, 80mg, 100mg, 120mg, and 150mg strengths of generic Enoxaparin Sodium (Preservative Free) Prefilled Syringes, a therapeutic equivalent for the reference listed drug (RLD) Lovenox® (Preservative Free) from Sanofi-Aventis US LLC.

Key Points: 
  • Techdow USA Inc. (“Techdow USA”), a growing market leader and vertically integrated generic injectables company, today announced the launch of its 30mg, 40mg, 60mg, 80mg, 100mg, 120mg, and 150mg strengths of generic Enoxaparin Sodium (Preservative Free) Prefilled Syringes, a therapeutic equivalent for the reference listed drug (RLD) Lovenox® (Preservative Free) from Sanofi-Aventis US LLC.
  • Enoxaparin Sodium (Preservative Free) Prefilled Syringes had US brand and generic sales of approximately $530 million, according to IQVIA Health over a 12-month period ending March 2023.
  • Techdow USA’s Enoxaparin Sodium (Preservative Free) Prefilled Syringes are supplied in 10-pack single-dose for subcutaneous (SQ) use.
  • Techdow USA is among the fastest growing companies in the US generic pharmaceutical industry, specializing in the sale of generic injectable pharmaceuticals.

Aquestive Therapeutics Reports Positive Results from Latest Clinical Studies Evaluating Pharmacokinetic and Pharmacodynamic Performance of Anaphylm ™ (epinephrine) Sublingual Film and Provides Findings from Recent Auto-Injector Clinical Study

Retrieved on: 
Wednesday, May 31, 2023
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“These data continue to show rapid absorption of epinephrine during the critical first ten minutes following administration of Anaphylm.

Key Points: 
  • “These data continue to show rapid absorption of epinephrine during the critical first ten minutes following administration of Anaphylm.
  • As our scientific advisors and the FDA have previously stated, anaphylaxis is a serious condition that must be treated quickly.
  • Simply put, every minute matters during a severe allergic reaction,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • “We are pleased to share the latest clinical results from our recent pilot studies confirming the rapidity of epinephrine delivery as we continue the progression of our Anaphylm development program.

AMGEN WINS PATENT APPEAL ON OTEZLA® (APREMILAST)

Retrieved on: 
Wednesday, April 19, 2023
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THOUSAND OAKS, Calif., April 19, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the District of New Jersey in a patent infringement lawsuit against Sandoz Inc. ("Sandoz") and Zydus Pharmaceuticals (USA), Inc. ("Zydus"). Today's decision affirms the permanent injunction entered by the district court prohibiting Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until February 2028.

Key Points: 
  • Three of Amgen's patents were the subject of the appeal.
  • The appellate court upheld the validity of U.S. Patent No.
  • 7,427,638, which claims pharmaceutical compositions of apremilast, and U.S. Patent No.
  • Before trial, both Sandoz and Zydus acknowledged that their generic versions of Otezla infringe the asserted claims of U.S. Patent No.