Pain related diseases such as cancer and diabetic neuropathy are highly prevalent in the Middle East where opioid such as fentanyl, morphine, oxycodone, and pethidine are used for the treatment. These opioids possess potent analgesic action, however, are highly addictive, whereas, tapentadol is mildly addictive and has higher safety and efficacy levels. Tapentadol may prove to be an effective alternative for pain management in Middle East region, where, opioid abuse is an issue. Nucynta extended release tablets is the only patented product available for tapentadol. Depomed, Inc. holds the patent for distribution and development of the drug tapentadol in the U.S. Janssen Pharmaceuticals along with Grünenthal GmbH, developer of the tapentadol molecule, filed a patent infringement lawsuit in the U.S., in 2013, against generic tapentadol manufacturers. Janssen Pharmaceuticals divested the drug development and distribution rights in the U.S. territory to Depomed, Inc. in 2015. Depomed won the case in April 2017 and all generics were subsequently pulled out of the market and are now banned till the patent expiry of tapentadol in 2025.
The Middle East tapentadol market is expected to gain significant traction, provided that the product distribution is restructured by the patent holder, globally. Support from the regulatory bodies in the Middle East, and increase in accessibility of tapentadol is expected to support growth of Middle East tapentadol market. Absence of major distribution channel for tapentadol in the Middle East has drastically reduced the import options. This provides immense opportunities for local players such as Teva Pharmaceutical Industries Ltd. to set up a distribution channel with the drug patent holder. Tapentadol is the only U.S. Food & Drug Administration approved opioid drug for treatment of diabetic neuropathic pain. Currently, only adults can consume tapentadol due to high therapeutic efficacy, which is not recommended for children. Whereas, ongoing clinical trials are expected to culminate in tapentadol being subjected to pediatric use, positive result of which, are expected to fuel growth of the Middle East tapentadol market over the forecast period.
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