Complex API & Formulations
Complex Active Pharmaceutical Ingredients (API) & Formulations
We are currently developing finished dosage formulations, or FDFs, and a portfolio of complex APIs for the development, manufacture and sale of generic pharmaceuticals. We specifically intend to develop FDFs for generic versions of branded drugs that are scheduled to come off patent until 2030 such as Fingolimod (Gilenya), including generic versions of the thrice-weekly 40 mg dosage of Copaxone® and Paliperidone Palmitate, which we expect to develop under abbreviated new drug applications, or ANDAs. Some of the FDFs we intend to develop will utilize complex APIs owned and developed by us.
Developing viable APIs can be complex due to the intricate, multiple production stages required and existing patent limitations of branded pharmaceuticals. Our proprietary know-how, which was developed in-house by our experienced personnel, allows us to develop products that avoid solid form and production process patent limitations. We believe the APIs and FDFs we are developing are particularly complex to manufacture and thus tend to have a high barrier to entry into the market, which we believe will limit the number of generic drug competitors. Our API manufacturing plant is located in Israel’s Neot Hovav industrial park is expected to manufacture our APIs and the Finished Dosage Forms (FDFs) are manufactured in our plant in Jerusalem.
Generic Pipeline & Paragraph IV Candidates
- API
- Medical Indication
- Branded Drug and Sale in 2016*
- MAPI Asset
- MAPI IP
- Glatiramer Acetate
- RRMS
- Copaxone® (Teva)
- API
- Fingolimod HCI Commercial
- RMS
- Gilenya (Novartis)
- API & FDF
- Processes US Granted
- Apremilast Commercial
- Psoriatic arthritis
- Otezia® (Celgene)
- API & FDF
- Polymorph US Granted
- Darunavir
- HIV
- Prezista® (J&J)
- API & FDF
- Processes (US/EP Granted) Polymorph US Granted
- Trabectedin
- Sarcoma
- Yondelis® (J&J)
- API
- Buspirone ER
- Anti-anxiety agent / Non-sedative / anxiolytic
- Actavis Inc; Bristol-Myers
- FDF
- Abiraterone Acetate (Para.IV)
- Prostate Cancer
- Zytiga® (J&J)
- API
- Processes US Granted
- Perampanel
- Epilepsy
- Fycompa® (Eisai)
- API & FDF
- Polymorph US Allowed
- Lurasidone HCI
- Schizophrenia
- Latuda® (DSP)
- API
- Processes US Granted
- Dronedarone HCI
- Atrial Fibrillation
- Multaq® (Sanofi)
- API
- Febuxostat
- Chronic Hyperuricemia
- Uloric® (Takeda)
- API
- Processes (PCT) Polymorph (PCT)
- Deferasirox
- Chronic Iron Overload
- Exjade® (Norvatis)
- API
- Processes & Polymorph US Granted EP Allowed
- Indacaterol Maleate
- Chronic Obstructive Pulmonary Disease
- Onbrez®, Arcapta (Novartis)
- API & FDF
- Tapentadol HCI
- Acute Pain
- Nucynta®, Palexia® (J&J)
- API
- Processes US Granted
- Alogliptin Benzoate
- Diabetes
- Nesina® (Takeda)
- API
- Processes US Granted
- Selexipag
- PAH - Pulmonary Arterial Hypertension
- Uptravi® (Nippon Shinyaku)
- API & FDF
- Polymorph (PCT)
- Dapagliflozin
- Type 2 Diabetes
- Forxiga® (BMS & AstraZeneca)
- API & FDF
- CO-CRYSTALS US Granted
- API: Active Pharmaceutical Ingredient
- FDF: Finished Dosage Form