Hikma launches Dicyclomine Hydrochloride Oral Solution

• Published Month : Thursday, 28 May 2020 03:00 pm

Receives first Competitive Generic Therapy Exclusivity from FDA

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has launched Dicyclomine Hydrochloride Oral Solution, USP, 10 mg/5 mL, an AA-rated version of Bentyl®1 Oral Syrup, 10 mg/5 mL in the United States through its US affiliate, Hikma Pharmaceuticals USA Inc.

Hikma's Dicyclomine Hydrochloride Oral Solution USP was approved with a Competitive Generic Therapy (CGT) designation from the US Food and Drug Administration. Hikma is the "first approved applicant" for this CGT and therefore is eligible for 180 days of CGT exclusivity which began upon commercial marketing of Hikma's product. 

Dicyclomine Hydrochloride Oral Solution is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

According to IQVIA, US sales of Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL were approximately $3 million in the 12 months ending March 2020.

Enquiries       Hikma Pharmaceuticals PLC
Susan Ringdal EVP, Strategic Planning and Global Affairs	+44 (0)20 7399 2760/ +44 7776 477050 uk-investors@hikma.uk.com
Steve Weiss David Belian US Communications and Public Affairs	+1 732 720 2830/ +1 732 788 8279 +1 732 720 2814/+1 848 254 4875 uscommunications@hikma.com

About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P)

Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

Important Safety Information for Dicyclomine Hydrochloride Oral Solution, USP, 10 mg/5 mL:

CONTRAINDICATIONS
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age, nursing mothers and in patients with:

• Unstable cardiovascular status in acute hemorrhage
• Myasthenia gravis
• Glaucoma
• Obstructive uropathy
• Obstructive disease of the gastrointestinal tract
• Severe ulcerative colitis
• Reflux esophagitis