famotidine/ibuprofen / Generic mfg. - LARVOL DELTA

Fixed drug eruption: exploring diagnostic considerations and triggers in a cohort study (EAACI 2025) - "In situ PTs, performed in 10 patients, identified causative drugs in 50% of cases: NSAIDs (n=3: etoricoxib, piroxicam), paracetamol (n=1), and bisacodyl (n=1)...Despite negative ST results, NSAIDs (etoricoxib, ibuprofen), famotidine, and metronidazole were strongly implicated in recurrent cases with consistent temporal relationships...While clinical diagnosis based on temporal relationships is effective in simple cases, in situ PTs identified the causative drug in 50% of cases and proved crucial in complex situations with multiple culprits. These findings emphasize the role of in situ PTs in improving diagnostic accuracy and guiding tailored management when the chronology alone is insufficient."

Allergy • Immunology

Zydus Lifesciences Secures USFDA Nod For Ibuprofen, Famotidine Tablets For Rheumatoid Arthritis (Medical Dialogues) - "Zydus Lifesciences Limited has announced that the Company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg. (USRLD: Duexis Tablets, 800 mg/26.6 mg)....Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoidarthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal ulcers), in patients who are taking ibuprofen for those indications."

ANDA • Osteoarthritis • Rheumatoid Arthritis

Stability-Indicating HPLC Method for Determination of Ibuprofen and Famotidine Degradation Products. (PubMed, J Chromatogr Sci) - "Studies have been completed and reported with two active substances in the combined dosage form and seven impurities in total. There is no method in the literature that simultaneously distinguishes and quantitatively analyzes both active substances and degradation products."

Journal

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS (Canada Newswire) - "Endo International plc...announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS....The combination medication is used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of developing ulcers of the stomach and upper intestines people may experience from ibuprofen alone."

Generic launch • Immunology • Osteoarthritis • Rheumatoid Arthritis

"Almost as bad as Duexis" (@NathanLevy10)

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $25.3 million, or 52%, to $23.6 million during the three months ended June 30, 2022, from $48.9 million during the three months ended June 30, 2021....DUEXIS. Net sales decreased $22.0 million, or 100%, to $0.1 million during the three months ended June 30, 2022, from $22.1 million during the three months ended June 30, 2021..."

Sales • Ankylosing Spondylitis • Back Pain • CNS Disorders • Osteoarthritis • Pain • Rheumatoid Arthritis

Comparison tables: H2-receptor antagonists and PPIs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Peptic Ulcer

HORIZON THERAPEUTICS PUBLIC LTD CO – 10-K – Management’s Discussion and Analysis of Financial Condition and Results of Operations (Insurancenewsnet) - "PENNSAID 2%. Net sales increased $13.6 million, or 8%, to $191.6 million during the year ended December 31, 2021, from $178.0 million during the year ended December 31, 2020....DUEXIS. Net sales decreased $51.3 million, or 41%, to $74.0 million during the year ended December 31, 2021, from $125.3 million during the year ended December 31, 2020....VIMOVO. Net sales decreased $29.2 million, or 78%, to $8.4 million during the year ended December 31, 2021, from $37.6 million during the year ended December 31, 2020."

Sales • Ankylosing Spondylitis • CNS Disorders • Immunology • Osteoarthritis • Pain • Rheumatoid Arthritis

Horizon Therapeutics suffers legal setback in its bid to block Duexis generic (SeekingAlpha) - "An Appeals court upheld a trial judge’s ruling to dismiss a patent claimed by Horizon Therapeutics...for rheumatoid arthritis therapy Duexis...U.S. Court of Appeals for the Federal Circuit also ruled that Indian pharma company, Alkem had not infringed a second patent for Duexis."

Corporate lawsuit • Ankylosing Spondylitis • Back Pain • CNS Disorders • Immunology • Pain • Rheumatoid Arthritis

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "DUEXIS. Net sales decreased $7.0 million, or 25%, to $20.9 million during the three months ended September 30, 2021, from $27.9 million during the three months ended September 30, 2020. The decrease in net sales was primarily due to the impact of generic competition on DUEXIS....On August 3, 2021, the FDA granted final approval for Alkem Laboratories, Inc.'s, or Alkem, generic version of DUEXIS and on August 4, 2021, Alkem launched its generic version of DUEXIS in the United States. While patent litigation against Alkem continues in the Federal Circuit Court of Appeals, we now face generic competition for DUEXIS, which has negatively impacted net sales of DUEXIS."

Generic launch • Sales • Back Pain • CNS Disorders • Osteoarthritis • Pain

Alkem labs launches Ibuprofen and Famotidine tablets in the United States (Business Standard) - "Alkem Laboratories announced the launch of Ibuprofen and Famotidine tablets (800 mg/26.6 mg) in the United States, following an approval from the United States Food and Drug Administration (US FDA)....Ibuprofen and Famotidine tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines LLC's Duexis tablets, 800 mg/26.6 mg....This combination medication is used to relieve pain from rheumatoid arthritis and osteoarthritis..."

Launch US • CNS Disorders • Immunology • Osteoarthritis • Pain • Rheumatoid Arthritis

Horizon Loses Patent Ruling to Alkem on Duexis Arthritis Drug (Bloomberg Law) - Subscription needed.

Patent • CNS Disorders • Osteoarthritis • Pain

Horizon Therapeutics plc Reports Record Third-Quarter 2020 Results; Increases TEPEZZA Full-Year Net Sales Guidance to Greater Than $800 Million; Increases Full-Year 2020 Net Sales and Adjusted EBITDA Guidance (Businesswire) - "Inflammation Segment (in millions ($) except for percentages): Q3 2020: PENNSAID 2%®: 0.3; DUEXIS®: 27.9; VIMOVO®: 5.3."

Sales • Back Pain • CNS Disorders • Osteoarthritis • Pain

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $16.4 million, or 32%, to $35.1 million during the three months ended June 30, 2020, from $51.5 million during the three months ended June 30, 2019....DUEXIS. Net sales decreased $2.3 million, or 8%, to $27.8 million during the three months ended June 30, 2020, from $30.1 million during the three months ended June 30, 2019....VIMOVO. Net sales decreased $8.4 million, or 57%, to $6.2 million during the three months ended June 30, 2020, from $14.6 million during the three months ended June 30, 2019."

Commercial • Sales • Osteoarthritis • Pain

Horizon Pharma: Corporate Presentation (Horizon Pharma) - Anticipated generic launch from Jan 1, 2023

Anticipated generic launch • Pain

Horizon Pharma reports 2013 financial results and provides business update (Marketwire) - "Full year 2013 DUEXIS gross and net sales were $85.5 million and $59.0 million, respectively; versus 2012 DUEXIS gross and net sales of $13.2 million and $10.3 million, increases of 548% and 473%, respectively....VIMOVO gross and net sales during the fourth quarter of 2013 were $1.0 million each..."

Sales • Pain

Duexis: Patent protection until 2026 (Horizon Pharma) - Investor Presentation

Patent • Pain

Horizon Pharma: Corporate Presentation (Horizon Pharma) - Anticipated exclusivity until 2023

Commercial • Demo Pain • Pain

Horizon Pharma announces settlement of Duexis patent litigation with Par Pharmaceutical (Marketwire) - "Horizon Pharma...today announced that it has entered into settlement and license agreements with Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc., to resolve pending patent litigation involving DUEXIS® (ibuprofen and famotidine) tablets. Under the license agreement, Horizon has granted Par the non-exclusive right to market a generic ibuprofen and famotidine product in the U.S. under Par's Abbreviated New Drug Application (ANDA), beginning January 1, 2023, or earlier under certain circumstances."

Anticipated generic launch • Corporate lawsuit • Pain

Horizon Pharma reports second quarter 2011 financial results (Marketwire) - US launch of Duexis remains on schedule for Q4 '11

Anticipated product launch • Pain

Horizon Therapeutics plc reports strong first-quarter 2020 financial results; increasing TEPEZZA full-year 2020 net sales guidance to greater than $200 million due to rapid uptake; increasing full-year 2020 net sales guidance (Businesswire) - "Inflammation Segment: (in millions...): Q1 20 - PENNSAID 2%®: 41.6...DUEXIS®: 31.3...VIMOVO®: 19.4."

Sales • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Horizon Therapeutics Plc (HZNP) Q4 2019 earnings call transcript - “Horizon Therapeutics Plc…as we look at the inflammation or primary care business side, our goal is to continue to manage the decline of this business while driving PENNSAID 2% and DUEXIS, we assume less than $5 million for the year for VIMOVO….Comment of the 2020 to 2023 timeframe, on the back end of that, we expect DUEXIS and RAYOS to become generic….In fact, we saw significant increase in the margin from the inflammation business in 2019 with roughly similar sales.”

Generic launch • Sales projection