![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
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
Details:
Cialis is a tablet having Tadalafil to treat erectile dysfunction, and symptoms of benign prostatic hyperplasia, and both ED and the signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor treatment that offers men a choice fot treatment of erectile dysfunction.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis
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:
Emifarma will be responsible for the initial stages of development and testing of the Company’s Mango ED products, including Mango ED, a combination of Tadalafil, Oxytocin, and L-Arginine, intended for the Mexican and Latin American markets.
Lead Product(s): Tadalafil,Oxytocin,L-Arginine
Therapeutic Area: Psychiatry/Psychology Product Name: Mango ED
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mangoceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 12, 2024
Details:
Opsynvi is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. It is approved for the chronic treatment of adults with pulmonary arterial hypertension.
Lead Product(s): Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Opsynvi
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 22, 2024
Details:
The net proceeds will be utilized for the commercialisation of Exordia (tadalafil), it comprises one of the three main PDE5 inhibitors. It is being evaluated in the treatment of erectile dysfunction.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Exordia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Digital Offering, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering February 20, 2024
Details:
Through the acquisition, Zuellig will have the access for Cialis (tadalafil), used to treat erectile dysfunction, and Alimta (pemetrexed), for the treatment of pleural mesothelioma and non-small cell lung cancer, from Eli Lilly.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zuellig Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 06, 2024
Details:
The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.
Lead Product(s): Finasteride,Tadalafil
Therapeutic Area: Urology Product Name: Entadfi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blue Water Vaccines
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 18, 2023
Details:
The Company intends to use the net proceeds to finance the marketing and operational expenses associated with the planned marketing of its Mango ED, a combination of Tadalafil, Oxytocin, and L-Arginine that have been traditionally used to treat sexual dysfunction.
Lead Product(s): Tadalafil,Oxytocin,L-Arginine
Therapeutic Area: Psychiatry/Psychology Product Name: Mango ED
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Boustead Securities
Deal Size: $1.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 15, 2023
Details:
DCGI has approved Tamsulosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil, a fixed dose combination within a hard gelatin capsule for the treatment of erectile dysfunction & benign prostatic hyperplasia.
Lead Product(s): Tamsulosin,Tadalafil
Therapeutic Area: Psychiatry/Psychology 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 November 15, 2023
Details:
CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.
Lead Product(s): Silodosin,Tadalafil
Therapeutic Area: Urology 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 November 07, 2023
Details:
Sweet Remedy (tadalafil) gummy is a PDE5 inhibitor, small molecule drug. It is being evaluated in phase 1 clinical trials for the treatment of patients with erectile dysfunction.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Sweet Remedy
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2023
Details:
DKF-313 is a combination of dutasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor). It is being evaluated in phase 3 clinical trials for the treatment of benign prostatic hyperplasia.
Lead Product(s): Dutasteride,Tadalafil
Therapeutic Area: Urology Product Name: DKF-313
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 September 26, 2023
Details:
The partnership aims bring its flagship product, Mango, a combination of Tadalafil, Oxytocin, and L-Arginine that have been traditionally used to treat sexual dysfunction, to New York.
Lead Product(s): Tadalafil,Oxytocin,L-Arginine
Therapeutic Area: Psychiatry/Psychology Product Name: Mango
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Greater NY Chamber of Commerce
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 09, 2023
Details:
ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.
Lead Product(s): Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D
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 June 26, 2023
Details:
Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).
Lead Product(s): Finasteride,Tadalafil
Therapeutic Area: Urology Product Name: Entadfi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 21, 2023
Details:
Profervia is a novel form of cilnidipine, a fourth-generation calcium channel blocker (CCB), which is investigated for the treatment of Raynaud's Phenomenon in Systemic Sclerosis (SSc).
Lead Product(s): Cilnidipine,Tadalafil
Therapeutic Area: Immunology Product Name: Profervia
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2023
Details:
Tadalafil Tablets phosphodiesterase inhibitor indicated for the treatment of pulmonary arterial hypertension and improve exercise capacity in men and women.
Lead Product(s): Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Adcirca-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 07, 2023
Details:
The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.
Lead Product(s): Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D
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 May 30, 2023
Details:
Cialis-generic (tadalafil) is an orally avilable PDE5 inhibitor USFDA approved drug candidate. It is approved in Mexico & Chile for the treatment of erectile dysfunction.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis-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 26, 2023
Details:
The acquisition transforms the Company into a broader pharmaceutical company spanning multiple sectors by including ENTADFI (finasteride), an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.
Lead Product(s): Finasteride,Tadalafil
Therapeutic Area: Urology Product Name: Entadfi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blue Water Vaccines
Deal Size: $100.0 million Upfront Cash: $20.0 million
Deal Type: Agreement April 20, 2023
Details:
A combination of opsumit (macitentan) and tadalafil is being investigated to improve pulmonary hemodynamics, where opsumit is an ERA antagonist and tadalafil relaxes blood vessels and lowers the blood pressure in lungs, to allow blood to flow more easily.
Lead Product(s): Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D
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 March 06, 2023
Details:
Cialis (tadalafil) is a selective phosphodiesterase-5 (PDE5) inhibitor that produces several downstream effects with the most common therapeutic effect being smooth muscle relaxation in the penis, allowing the corpus cavernosum to fill with blood to produce an erection.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis
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 07, 2023
Details:
Tadliq is the first and only FDA-approved liquid oral suspension of tadalafil for adult patients with difficulty swallowing. Tadliq is indicated for the treatment of pulmonary arterial hypertension and ensures consistent dosing.
Lead Product(s): Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tadliq
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 24, 2022
Details:
In the USA all clinically proven oral ED therapies are prescription-only and therefore FM71/MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for ED treatment.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: MED3000
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 31, 2022
Details:
Cialis® (tadalafil), is indicated for the treatment of erectile dysfunction and benign prostatic hyperplasia, and Cialis® is positioned as the top 2 brand product for erectile dysfunction treatment with high brand loyalty.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lotus Pharmaceutical Industries
Deal Size: $57.5 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 22, 2022
Details:
ENTADFI (finasteride and tadalafil) capsules for oral use, a new treatment for urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia.
Lead Product(s): Finasteride,Tadalafil
Therapeutic Area: Urology Product Name: Entadfi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
Finasteride and tadalafil combination is used to treat men with benign prostatic hyperplasia (BPH). Tadalafil is a PDE5 inhibitor and finasteride blocks the action of 5-alpha-reductase which will increase testosterone levels in the body, which decreases prostate size.
Lead Product(s): Finasteride,Tadalafil
Therapeutic Area: Urology Product Name: Finasteride/Tadalafil-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 26, 2021
Details:
Health Canada approved OPSYNVI® (macitentan 10mg and tadalafil 40mg) for long-term treatment of pulmonary arterial hypertension. Macitentan is antagonist/blocker of endothelin receptors on blood vessels and smooth muscle, and tadalafil is a selective inhibitor of PDE5.
Lead Product(s): Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Opsynvi
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 15, 2021
Details:
Partnership will support the development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction (“ED”) and benign prostatic hyperplasia (BPH).
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: AQST-119
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IntelGenx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 29, 2021
Details:
Cialis®, and the generic equivalent Tadalafil, is in a class of medications called phosphodiesterase (PDE) inhibitors. Tadalafil is used to treat erectile dysfunction and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate).
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ECI Pharmaceuticals LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 10, 2021
Details:
Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology 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 December 31, 2020
Details:
Tadalafil Tablets is a phosphodiesterase inhibitor that indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.
Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Cialis-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 December 31, 2020
Details:
While the primary endpoint was not met, exploratory analysis suggests a signal of reduced risk of disease progression of initial triple oral combination therapy vs initial double oral therapy for Pulmonary Arterial Hypertension (PAH) patients .
Lead Product(s): Selexipag,Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Uptravi
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 29, 2020