TABLE OF CONTENTS. 4. Formulation Opportunities Oral Reformulation Taste Masking MCD GROUP, LLC October
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1 TABLE OF CONTENTS 1. Executive Summary... 9 Market Overview... 9 Drug Delivery Systems for Pediatrics Formulation Opportunities Specialty Pediatric Companies Product Licensing Opportunities Pediatric Market Overview Market Needs Therapeutic Needs Hypertension Hypercholesterolemia Diabetes Pain Management Anti-Infectives Respiratory / Allergy Attention Deficit Hyperactivity Disorder Epilepsy Market Size Key Therapeutic Areas CNS Allergies Asthma Infections Drug Delivery Systems for Pediatrics Marketed Products Dosage Forms Taste Masking Orally Disintegrating Dosage Forms Soft Chewable Delivery Systems Oral Liquid Delivery Systems Oral Mucosal Delivery Systems Transdermal Delivery Systems Topical Delivery Systems Nasal Drug Delivery Pulmonary Delivery Systems Parenteral and Device Technologies Formulation Opportunities Oral Reformulation Taste Masking
2 Non-invasive Formulations Companies with Pediatric Focus Adamis Pharmaceuticals Corporation Aires Pharmaceuticals, Inc Arbor Pharmaceuticals, Inc Asklepion Pharmaceuticals, Inc Centrix Pharmaceutical, Inc Cornerstone Therapeutics, Inc Curemark, LLC FSC Pediatrics, Inc InfaCare Pharmaceutical Corporation Lupin Pharmaceuticals, Inc Madeira Therapeutics McNeil Pediatrics Meritage Pharma, Inc Next Wave Pharmaceuticals, Inc ParaPRO, LLC Pediapharm, Inc Pernix Therapeutics Holdings, Inc Reckitt Benckiser Pharmaceutical, Inc Seaside Therapeutics, Inc Shionogi Pharma, Inc TaroPharma Teva Respiratory, LLC Tiber Laboratories, LLC Topaz Pharmaceuticals, Inc TRx Pharma Drug Delivery Technologies for Pediatric Drugs Buccal Delivery Systems APTYS Pharmaceuticals Biodel, Inc BioDelivery Sciences International Corium International, Inc Fertin Pharma NovaDel Pharma Orexo AB ULURU, Inc Watson, Inc Oral Delivery Systems Acino Holding, Ltd Akina, Inc Alpex Pharma Alte Biosciences, Inc
3 Aprecia Pharmaceuticals Company Arx, LLC Banner Pharmacaps Capricorn Pharma, Inc Catalent Pharma Solutions CIMA Labs, Inc Collegium Pharmaceutical, Inc Dow Wolff Cellulosics Egalet A/S Ethypharm Eurand, Inc Eurand, Inc ForTe BV Grunenthal GmbH HealthSport, Inc IntelGenx Corporation KV Pharmaceutical Company Labtec Pharma Lavipharm Losan Pharma GmbH LTS Lohmann Meldex International, PLC MonosolRx NAL Pharmaceuticals, Ltd Pharmafilm S.r.l Physica Pharma SPI Pharma Inc Tris Pharma Xel Pharmaceuticals, Inc Taste Masking Technologies Balchem Corporation Cambrex Corporation Ethypharm Eurand, Inc ForTe BV Oralance Pharma Nasal Technologies Ikano Therapeutics, Inc OptiNose Dermal Delivery Technologies Altea Therapeutics Foamix, Ltd ForTe BV Intercell
4 nanobiosciences, LLC Pantec Biosolutions Quinnova Pharmaceuticals, Inc TransPharma Medical Zosano Pharma Product Licensing Opportunities Albuterol Dry Powder Inhaler Allergy Chewing Gum Atopic Dermatitis Treatment Atopiclair TM Cream CRO-PED for Pediatric Diarrhea Children s Dietary Supplement Ciprofloxacin Otic Solution Cough/Cold Pediatric Formulations Decongestant Cream Stick Decongestant Patch Fever Cooling Patch Foam-Based Dermatology Products Foam-Based Products for Infants GastroGard-R for Rotavirus Hedrin TM for the Treatment of Head Lice Human Growth Hormone Nasal Spray Insect Repellent Patch Insecticide-Free Head Lice Treatment Liposomal Amikacin Formulation Long-acting Somatropin Injection Moisturizing Cream for Dermatitis Nasal Somatropin Formulation NeoCeram TM Skin Barrier Emulsion Novel Head Lice Formulation Once-weekly Injectable Somatropin Oral Film Formulation of Prednisolone Oral Rotavirus Thin Film Product Orally Disintegrating Acetaminophen Formulations Orally Disintegrating Allergy Products Pediatric Pain Formulations Peptide for Chronic Middle Ear Infections Sinlice, Pediculicide Treatment Site-Specific Otitis Media Treatment Sustained Release Somatropin Injection Teething Gel for Babies Zinc Oxide Spray
5 INDEX OF TABLES Table 1: Pediatric Age Related Subgroups Table 2: Antihypertensives Granted Pediatric Exclusivity Table 3: Cholesterol Drugs Granted Pediatric Exclusivity Table 4: Diabetes Products Used in Pediatrics Table 5: Pain Medications Granted Pediatric Exclusivity Table 6: Emerging Technologies for Antibiotics Table 7: Leading Respiratory/Allergy Products for Pediatrics Table 8: ADHD Medications for Pediatrics Table 9: Drugs Approved for Epilepsy Figure 1: US Prescription Pediatric Market, Table 10: Sales of 25 Drugs Commonly Prescribed to Pediatrics Table 11: Sales of Leading Pediatric-Focused Products, Table 12: Sales of Leading ADHD Drugs, Table 13: Sales of Leading Prescription Allergy Drugs, Table 14: Sales of Leading Asthma Drugs, Table 15: Pediatric Oral Antibiotic Market Table 16: DDS Products Approved for Pediatric Use Table 17: OTC DDS Products for Pediatrics Table 18: Key Players in Taste Masking Table 19: ODT Technology Summary Table 20: Key Players in ODT Market Table 21: Oral Film Technology Summary Table 22: Key Players in Oral Film Market Table 23: ODD Pipeline Products for Pediatrics Table 24: Advantages of Chewable Dosage Forms Table 25: Soft Chewable Delivery Systems Table 26: Liquid Drug Delivery Technologies Table 27: Liquid Pediatric Products in Development Table 28: Key Players in Buccal Delivery Table 29: Transdermal Pediatric Products Table 30: Transdermal Pipeline for Pediatrics Table 31: Topical Pediatric Pipeline Table 32: Nasal Pipeline Products Applicable to Pediatrics Table 33: Pulmonary Pipeline for Pediatrics Table 34: Parenteral DDS Pediatric Pipeline Table 35: Pediatric Drug Candidates for Oral Reformulation Table 36: Taste Masking Development Opportunities Table 37: Non-invasive Reformulation Opportunities Table 38: Arbor Product Pipeline Table 39: Asklepion Pipeline Table 40: Pediatric Products of Centrix Table 41: Therapeutic Targets of Centrix
6 Table 42: Cornerstone Products Prescribed to Pediatrics Table 43: Madeira Product Pipeline Table 44: McNeil s Pediatric Product Developments Table 45: NextWave Pipeline Products Table 46: Pediapharm Pipeline Table 47: Marketed Products by Reckitt Benckiser Table 48: Pediatric Products Marketed by Shionogi Table 49: Shionogi Pediatric Pipeline Table 50: NonSpil OTC Products Table 51: Rx Products Marketed by Taro Table 52: Teva s Key Products for Pediatrics Table 53: Tiber Laboratories Product Portfolio Table 54: VIAdel Pipeline Table 55: NovaDel Pipeline Table 56: Orexo s Sublingual Pipeline Table 57: Alpex Pipeline Table 58: Marketed Zydis Products Table 59: Catalent Product Pipeline Table 60: Products Developed by CIMA Table 61: Ethypharm s ODT Products Table 62: Eurand s ODT Products Table 63: HealthSport Products Table 64: Labtec Products Table 65: LTS Wafer Systems Table 66: Meldex DDS Pipeline Table 67: MonosolRx Pipeline Table 68: Malt-o-Fast Comparative Data Table 69: Tris Product Pipeline Table 70: Products Containing Microcaps Technology Table 71: NODS Pipeline Table 72: OptiNose Pipeline Table 73: PassPort TM Product Pipeline Table 74: ViaDerm Pipeline Table 75: Foamix Pipeline Products
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