Orange Book

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
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Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

Key Points: 
  • Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.
  • These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
  • Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor, in Hippo mutant solid tumors in the first half of 2024.
  • A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

Sterne Kessler Secures Non-Infringement Win for Teva Pharmaceuticals

Retrieved on: 
Friday, January 5, 2024
Orange Book, Teva, Syndrome, FDA, The Orange Book, Therapy, Cushing's syndrome, Mifepristone, Type, Corcept Therapeutics, Teva Pharmaceuticals, Patient, Prediabetes, Generic drug

WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.

Key Points: 
  • WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.
  • On December 29, 2023, the district court held that Teva does not infringe the two patents asserted at trial, finding that Corcept had failed to show that direct infringement is likely or that Teva's label would induce infringement.
  • Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products.
  • Corcept Therapeutics, Inc., the holder of the Korlym NDA, filed a Hatch-Waxman lawsuit against Teva alleging infringement of two patents listed in the Orange Book for Korlym.

Cosette Pharmaceuticals Acquires Vyleesi® (Bremelanotide Injection) from Palatin Technologies Inc.

Retrieved on: 
Wednesday, January 3, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, Patient, Orange Book, HSDD, Multimedia, Woman, Acquisition, Medication, Education, Bremelanotide, PTN, Female, Urology

Cosette Pharmaceuticals, Inc. (“Cosette”), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.

Key Points: 
  • Cosette Pharmaceuticals, Inc. (“Cosette”), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.
  • Palatin and Cosette will ensure continued patient and healthcare professional access to Vyleesi® throughout the transition period.
  • Cosette offers patients the ability to connect with a physician through a telemedicine option.
  • Patients and providers can learn more about HSDD and Vyleesi®, including Important Safety Information, at www.vyleesi.com .

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

Retrieved on: 
Wednesday, January 3, 2024
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“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
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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
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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.