API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
EU WC
Listed Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
USFDA approved generic version of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Advil-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
USFDA approved generic version of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Motrin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2022
Details:
Strides Pharma's Ibuprofen is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Children's Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Advil-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2023
Details:
The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.
Lead Product(s): Ibuprofen,Paracetamol
Therapeutic Area: Neurology Product Name: Advil-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
Duexis-Generic (ibuprofen-famotidine) version will commercialize by the Endo. The combination medication is used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Lead Product(s): Ibuprofen,Famotidine
Therapeutic Area: Immunology Product Name: Duexis-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2024
Details:
Combogesic IV (acetaminophen & ibuprofen) is a opioid-free pain relief medicine. It is approved by USFDA for use in adults for relief of mild to moderate pain & the management of moderate to severe pain as an adjunct to opioid analgesics.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Combogesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2024
Details:
Combogesic IV (acetaminophen & ibuprofen) is a opioid-free pain relief medicine. It is approved by USFDA for use in adults for relief of mild to moderate pain & the management of moderate to severe pain as an adjunct to opioid analgesics.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Combogesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2024
Details:
Maxigesic via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Details:
Caldolor (ibuprofen) is an USFDA approved NSAID, functions by the inhibiting of cyclooxygenase (COX-1 and COX-2), for the treatment of fever & pain in infants.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Caldolor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
Details:
Maxigesic® via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Details:
Ibuprofen and pseudoephedrine hydrochloride is a combination of NSAID and alpha-adrenergic stimulator which is used to relieve symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose.
Lead Product(s): Ibuprofen,Pseudoephedrine Hydrochloride
Therapeutic Area: Neurology Product Name: Ibuprofen/Pseudoephedrine Hydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Details:
Acetaminophen and Ibuprofen acts by inhibiting cyclooxygenases (COX-1 and COX-2), and thus prostaglandins, which are produced by the body in response to injury and inflammation.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Acetaminophen/Ibuprofen-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
Maxigesic (paracetamol) IV is a novel, dual mode-of-action, non-opioid pain treatment delivered through intravenous (IV) infusion for use post-operatively in hospitals or when patients cannot take medicine orally.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AFT Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 24, 2023
Details:
The superior analgesic effect of Maxigesic IV (paracetamol) demonstrated in a phase 3 trial was supported by a range of secondary endpoints, including reduced opioid consumption compared to the paracetamol IV and ibuprofen IV treatment groups (P<0.005).
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic IV
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2022
Details:
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Caldolor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
The results showed an increase of COX-2 inhibition in the polarized sample when compared to the non-polarized sample, where the inhibition was 257.67% higher than the non-polarized sample of ibuprofen.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Details:
Global pharma major Lupin Limited announced the launch of the authorized generic version of Duexis (ibuprofen and famotidine) tablets, 800 mg/26.6 mg, of Horizon Medicines.
Lead Product(s): Ibuprofen,Famotidine
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2021
Details:
Nuromol is used for mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic, muscular pain, pain of non-serious arthritis, cold-flu symptoms, sore throat & fever when paracetamol or ibuprofen alone have not provided pain relief.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Nuromol
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MHRA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
Ibuprofen and Famotidine Tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis® Tablets, 800 mg/26.6 mg.
Lead Product(s): Ibuprofen,Famotidine
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2021
Details:
Maxigesic IV (a unique combination of 1000 mg paracetamol and 300 mg ibuprofen solution for infusion) is a novel, patented, non-opioid pain treatment, and is being commercialised by Hyloris’ partner AFT Pharmaceuticals.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic IV
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hyloris Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 24, 2021
Details:
Hikma gets rights for the sales, marketing and distribution of Combogesic® IV in the US. Combogesic® IV is a patented intravenous formulation developed as a line extension to Maxigesic tablets, used post-operatively in hospitals when patients cannot take a medicine orally.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Combogesic IV
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 28, 2021
Details:
According to IQVIA data for the 12 months ended December 2020, total U.S. generic sales of Ibuprofen tablets 400 mg, 600 mg, 800 mg was approximately $110 million. Generic Folic Acid tablets 1 mg were approximately $20 million for the same period.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Product Name: Ibuprofen-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ECI Pharmaceuticals LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 23, 2021
Details:
The IPO is expected to provide the Company with the resources needed to finance the development of its existing portfolio of product candidates, as well as establish a commercial infrastructure in the United States for its IV Cardiovascular portfolio.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Product Name: Maxigesic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering June 03, 2020
Details:
Trial to evaluate formulation of ibuprofen treatment for treating severe acute respiratory distress syndrome (ARDS), a complication of COVID-19, has launched in south London.
Lead Product(s): Ibuprofen
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
The collaboration aims at providing hospitals and clinics that use Caldolor® injection for the treatment of COVID-19 patients easy access financial arrangements to combat medical requirements.
Lead Product(s): Ibuprofen
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 31, 2020
Details:
Study has found that there is no evidence for or against the use of non-steroidal anti-inflammatory drugs such as ibuprofen for patients with COVID-19.
Lead Product(s): Ibuprofen
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020