Sun Pharma Launches (C)Taro-Methylphenidate ER, the First and Only Bioequivalent to Concerta® with an Osmotic Delivery System

MUMBAI, India and BRAMPTON, ON, Sept. 24, 2026 /CNW/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced the commercial availability of Taro-Methylphenidate ER for Canadian patients in Ontario and Quebec.

Taro-Methylphenidate ER is the first and only bioequivalent to Concerta® with an osmotic delivery system indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older.

Taro-Methylphenidate ER

"Finding the right treatment for someone with ADHD can be complicated," said Dr. Angelo Fallu, psychiatrist.  "For the first time, we have not only a bioequivalent option but a molecule that uses the osmotic delivery system our patients have relied on for over 20 years to control their symptoms from morning to evening. This treatment option represents the only alternative with an osmotic delivery system available for our patients taking Concerta^®."

ADHD is one of the most common neurodevelopmental disorders and is often diagnosed in childhood. ADHD presents as persistent inattention, hyperactivity, and impulsivity that lead to significant functional impairments. It is estimated that 5.4% of Canadians have ADHD.ⁱ

"The osmotic delivery system in Taro-Methylphenidate ER maintains a stable and effective concentration of treatment throughout the day," said Dr. Martin Katzman, Psychiatrist and Clinic Director. "The osmotic delivery system acts to minimize the peaks, troughs, and variability sometimes seen in other formulations that can compromise real-world functioning and patient outcomes in ADHD."

"Taro-Methylphenidate ER is the only generic with data from two rigorous randomized crossover studies to demonstrate patient stability across normal days when switching from the brand name product," said Joel Lamoure, community and hospital pharmacist. "Maintaining restorative functionality in the patient can be achieved through consistent osmotic-based medication delivery systems. The patient's body cannot tell the difference between Taro-Methylphenidate ER and the branded product, and that is huge for ADHD patients and their stability."

"Sun Pharma is excited to launch this much-anticipated, osmotic delivery formulation of methylphenidate as a lower-cost alternative to Concerta® for the over 2 million Canadians affected by ADHD," said Raffaele Spadafora, Head of Specialty Generics.

Taro-Methylphenidate ER is currently reimbursed by Régie de l'assurance maladie du Québec (RAMQ) in Quebec and the Ontario Public Drug Program (OPDP).

"We continue to work with public and private formularies to support patient access in every province across the country" said Barb Pimentel, General Manager Generics and Consumer Healthcare, Sun Pharma. 

About Taro-Methylphenidate ER 
Taro-Methylphenidate ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in:

• children (6-12 years of age)
• adolescents (13-18 years of age)
• adults (>18 years of age)

-    Should not be taken by children under 6 years of age
-    No data available in patients over 65 years of age
-    The effectiveness of Taro-Methylphenidate ER for more than 4 weeks in children and adolescents or 7 weeks in adults has not been systematically evaluated. If used for extended periods, physician should periodically re-evaluate.

Contraindications:
Taro-Methylphenidate ER is contraindicated in:
• Patients who are hypersensitive to methylphenidate or to any ingredients in the formulation or component of the container, thyrotoxicosis, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, glaucoma, during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result)

Most serious warning and precautions: 
• Drug dependence

Other relevant warnings and precautions: 
• General (oral use only), Fatigue, Information for patients, Carcinogenesis and Mutagenesis, hypertension and other cardiovascular conditions, pre-existing cardiovascular and cerebral vascular conditions, Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems, Peripheral vasculopathy, including Raynaud's phenomenon, Drug dependence, Driving and operating machinery, Thyrotoxicosis, Long-term suppression of growth, Potential for gastrointestinal obstruction, monitoring and laboratory tests, cerebrovascular disorders, Motor and verbal tics, and worsening of Tourette's, Serotonin toxicity/serotonin syndrome, Increased intraocular pressure and glaucoma, Aggression, anxiety and agitation, Emergence of new psychotic or manic symptoms, Pre-existing psychosis, Screening patients for bipolar disorder, Suicidal behaviour and ideation, Priapism, Teratogenicity, Pregnancy women, Breast-feeding, Geriatrics, Pediatrics 

For more information: 
• For important information on conditions of clinical use, contraindications, warnings, precautions, adverse reactions, drug interactions and dosing, please consult the product monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp. The product monograph is available by calling Sun Pharma Inc at 1-800-268-1975.

About Sun Pharma in Canada
Sun Pharma combines the power of a global network with localized research and care to address the unmet needs of Canadian patients, and health care providers, consistent with the Company's vision of Reaching People. Touching Lives.

Sun Pharma offers a wide range of affordable medicines for the Canadian population in specialty and niche segments coupled with a presence in the top 15 Canadian generic products.

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)
Sun Pharma is a leading global pharmaceutical company with a presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology and accounts for about 22% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across five continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations.

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ⁱ Lamoure, J., Fallu, A., Handelman, K., & Katzman, M. (2026). ADHD management in practice: Why the choice of methylphenidate formulation matters for restorative functionality. International Journal of Science and Research (IJSR), 1561–1567. https://doi.org/10.21275/sr26223193548

SOURCE Sun Pharma Canada Inc.

Sun Pharma Contacts: Investors: Dr. Abhishek Sharma, Tel: [phone], Ext 2929, Tel Direct: [phone], Mobile: [phone], Email: [email protected]; Media: Rob Perry, Head of North America Corporate Communications, Email: [email protected]