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Details:
Under the collaboration, FAMAR will undertake the production of two pharmaceutical products recently added to Lavipharm’s portfolio of analgesic pharmaceutical products, Lonarid N (paracetamol) and Lonalgal (caffeine Anhydrous).
Lead Product(s): Paracetamol,Caffeine
Therapeutic Area: Immunology Product Name: Lonarid N
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: LaviPharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 23, 2024
Details:
Strides Pharma has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the U.S Food & Drug Administration. The product is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Lead Product(s): Butalbital,Paracetamol,Caffeine
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 September 22, 2020
Details:
USFDA approved generic version of Butalbital, Acetaminophen, Caffeine with Codeine Phosphate Capsules which is indicated for the relief of the symptom complex of tension headache (migraine).
Lead Product(s): Butalbital,Paracetamol,Caffeine
Therapeutic Area: Neurology Product Name: Fioricet-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 09, 2020
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:
F14 (celecoxib) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
Lead Product(s): Celecoxib,Bupivacaine Hydrochloride,Paracetamol
Therapeutic Area: Neurology Product Name: F14 (mdc-CWM)
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 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:
Acetaminophen reduces COX pathway activity and is thought to inhibit the synthesis of prostaglandins in the central nervous system, leading to its analgesic and antipyretic effects.
Lead Product(s): Paracetamol
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 April 18, 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:
Acetaminophen injection is indicated to relieve mild-to-moderate pain, and to reduce fever. It is also used in combination with opioid (narcotic) medications to relieve moderate-to-severe pain.
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-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 October 29, 2022
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:
With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for the product candidates, NVK009 (Gabapentin). Endo's Par Sterile Products business will commercialize the products in the United States.
Lead Product(s): Gabapentin,Pregabalin,Paracetamol
Therapeutic Area: Neurology Product Name: NVK009
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Endo International
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 02, 2022
Details:
The first OTC pain relievers containing acetaminophen without artificial dyes, fillers, and preservatives to launch at Walmart and other national retailers,rovides temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-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 27, 2022
Details:
The combination with Custopharm enhances Hikma’s R&D capabilities and pipeline and expands Hikma’s differentiated US portfolio to close to 130 commercialised injectable medicines – a more than fivefold increase over the last decade, including Acetaminophen injection.
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: $425.0 million Upfront Cash: $375.0 million
Deal Type: Acquisition April 21, 2022
Details:
Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/325 mg/40 mg, a therapeutic equivalent of reference listed drug Butalbital, Acetaminophen, and Caffeine capsules of Mayne Pharma, indicated for relief of symptom complex of tension (or muscle contraction) headache.
Lead Product(s): Butalbital,Paracetamol,Caffeine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Senores Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2022
Details:
LIMITx™ LTX-03, works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and systemic absorption of active from micro-particles contained in the LIMITx tablets.
Lead Product(s): Hydrocodone Bitartrate,Paracetamol
Therapeutic Area: Neurology Product Name: LTX-03
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abuse Deterrent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 01, 2022
Details:
In clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level up to 34% when exposed to higher buffer ingredient levels.
Lead Product(s): Hydrocodone Bitartrate,Paracetamol
Therapeutic Area: Neurology Product Name: LTX-03
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
The company has entered into a formal agreement with Evolution Research Group (ERG), a leading postsurgical pain clinical research site network in the U.S., to conduct its registration trials with CA-008 (vocacapsaicin).
Lead Product(s): Vocacapsaicin,Ketorolac Trometamol,Paracetamol
Therapeutic Area: Neurology Product Name: CA-008
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Evolution Research Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 02, 2022
Details:
URMC will participate in the vocacapsaicin Phase 3 clinical trials and develop innovative methods to capture vocacapsaicin’s benefit to patient recovery and rehabilitation.
Lead Product(s): Vocacapsaicin,Ketorolac Trometamol,Paracetamol
Therapeutic Area: Neurology Product Name: CA-008
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: University of Rochester Medical Center
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 02, 2022
Details:
Concentric intends to use the proceeds from the financing to further fund Phase 3 development activities for vocacapsaicin, its lead therapeutic candidate for postsurgical pain.
Lead Product(s): Vocacapsaicin,Ketorolac Trometamol,Paracetamol
Therapeutic Area: Neurology Product Name: CA-008
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 26, 2022
Details:
The combination with Custopharm enhances Hikma’s R&D capabilities and pipeline and expands Hikma’s differentiated US portfolio to close to 130 commercialised injectable medicines including Acetaminophen injection– a more than fivefold increase over the last decade.
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: $425.0 million Upfront Cash: $375.0 million
Deal Type: Acquisition September 27, 2021
Details:
Acetaminophen extended-release tablets are bioequivalent to the reference listed drug, Tylenol extended-release tablets, 650 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-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 August 27, 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:
LTX-03 is an immediate-release hydrocodone bitartrate with acetaminophen tablet. The agreement aims at extending the FDA Acceptance Date for LTX-03 to February 28, 2022.
Lead Product(s): Hydrocodone Bitartrate,Paracetamol
Therapeutic Area: Neurology Product Name: LTX-03
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abuse Deterrent Pharma, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 26, 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:
Venus Remedies had initiated the legal battle in order to remove any patent hurdle in manufacturing of intravenous paracetamol solution in the country.
Lead Product(s): Paracetamol
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 June 17, 2021
Details:
LTX-03 (hydrocodone with acetaminophen) demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose.
Lead Product(s): Hydrocodone Bitartrate,Paracetamol
Therapeutic Area: Neurology Product Name: LTX-03
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 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:
The US Food & Drug Administration (US FDA) has approved Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).
Lead Product(s): Paracetamol,Aspirin,Caffeine
Therapeutic Area: Neurology Product Name: Acetaminophen/Aspirin/Caffeine-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 February 24, 2021
Details:
One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart.
Lead Product(s): ChAdOx1 nCoV-19,Paracetamol
Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: University of Oxford
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Aurobindo Pharma has received final approval from the US Food & Drug Administration (FDA) to manufacture and market acetaminophen injection, 1,000 mg/ 100 mL single-dose vial (SDV).
Lead Product(s): Paracetamol
Therapeutic Area: Neurology Product Name: Acetaminophen-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 October 23, 2020
Details:
DSE Healthcare Solutions recharges its legacy brand VANQUISH® to meet the needs of today's consumer with the launch of VANQUISH® DIGITAL HEADACHE™ Brand Pain Reliever.
Lead Product(s): Paracetamol,Aspirin,Caffeine
Therapeutic Area: Neurology Product Name: Vanquish
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, 2020
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:
In conjunction with a third party formulation developer, the formulation and manufacturing process for LTX-03 has been optimized for commercial scale.
Lead Product(s): Hydrocodone Bitartrate,Paracetamol
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2020
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FAMAR CDMO- From early development to commercial manufacturing.
