Animal Pharm Generics – New Edition 2017

ReportsWorldwide has announced the addition of a new report title Animal Pharm Generics – New Edition 2017 to its growing collection of premium market research reports.
By: ReportsWorldwide
 
BOSTON - Nov. 23, 2017 - PRLog -- In 2015, the global animal health market was worth an estimated $30bn. This new thoroughly revised and updated Animal Pharm Generics report focuses primarily on the European and North American markets that comprise around 67% of the global market for animal health products. Also fully reviewed are the EU and North American veterinary generics markets, with a specific focus on veterinary pharmaceuticals (such as anti-infectives and parasiticides), as well as medicinal feed additives where appropriate.

The global animal health market is dominated by pharmaceuticals (57% of sales), biologicals (29%) and medicinal feed additives (14%).
While medicated feed is cheap, using primarily established active ingredients (AIs) and often antimicrobials produced in bulk as a commodity product, increasing regulation is making this sector less attractive.

Products based on patented AIs are probably worth just 5% of the market, which reflects a lack of innovation, that many AIs are out of patent, and that pioneer companies frequently retain the controlling share.

Because of the huge costs involved, generic biologicals (or biosimilars) will only be open to large players. The high molecular complexity, multifaceted production methods and stability issues, coupled with smaller returns than for human pharmaceuticals, may prove insurmountable for smaller companies.

To view a detailed description and Table of Contents please visit:https://www.reportsworldwide.com/report/animal-pharm-generics—new-edition-2017 (https://www.reportsworldwide.com/report/animal-pharm-gene...)

Executive Summary 11
1. Overview 15
1.1 Focus of the report 15
1.2 Definition of generics 15
1.2.1 EU definition 16
1.2.2 US definition 16
1.3 Naming conventions 16
1.3.1 Identifiers 16
1.3.2 INN 17
1.4 Counterfeit medicines 17
1.5 Evolution of human and animal medicine market 18
1.6 Cost of developing new products 18
1.7 Emergence of generics 18
1.8 Innovation impeded 19
1.9 References 20
2. Intellectual Property 21
2.1 Summary 21
2.2 Introduction 21
2.3 WIPO 22
2.4 Patents 23
2.4.1 Types of patent 23
2.4.2 Company example 24
2.4.3 Points of note 24
2.5 Filing a patent 25
2.6 PCT 28
2.7 WTO and TRIPS 28
2.8 Patent situation in the EU 29
2.8.1 Overview 29
2.8.2 Establishment of an EU unitary patent 30
2.9 Patent situation in the US 31
2.10 Patent situation in India 31
2.10.1 Overview 31
2.10.2 Compulsory licenses 32
2.11 Patent situation in China 33
2.12 Extended patent protection 33
2.12.1 EU – Supplementary Protection Certificates 34
2.12.2 US – Hatch-Waxman legislation 34
2.13 Experimental use exceptions ("Bolar" exemptions) 35
2.13.1 EU 35
2.13.2 US 36
2.14 Registration data exclusivity 36
2.15 Trademarks 36
2.15.1 Background 36
2.15.2 Think Outside the Box 37
2.15.3 Plan Ahead 38
2.15.4 Select Alternate Names 38
2.15.5 Trademark Clearance 38
2.15.6 Invest in Targeted Protection 38
2.16 References 38
3. Registration issues 41
3.1 Summary 41
3.2 Abridged registration for generics 41
3.3 US 42
3.3.1 Veterinary pharmaceuticals approved under the FDA 42
3.3.1.1 Market exclusivity 42
3.3.1.2 Registration requirements 43
3.3.1.3 Suitability Petition 44
3.3.1.4 Fees 45
3.3.1.5 Bioequivalence 46
3.3.2 Ectoparasiticides approved under the EPA 46
3.3.3 Veterinary biologics approved under the USDA 47
3.4 EU 48
3.4.1 Legal background 48
3.4.2 Abridged applications for generics 49
3.4.2.1 Directive 2001/82/EC 49
3.4.2.2 Directive 2004/28/EC 49
3.4.3 Registration procedures 50
3.4.4 Proposal for a veterinary medicinal products regulation (revising Directive 2001/82/EC and Directive 2004/28/EC) 51
3.4.4.1 Overview of Commission proposal 51
3.4.4.2 Increased data protection proposals 52
3.4.4.3 EU-wide database 53
3.4.4.4 ComAgri amendments 53
3.4.4.5 ComEnvi amendments 54
3.4.4.6 Proposal for a medicated feed regulation (revising Directive 90/167/EEC) 54
3.4.4.7 Proposal for a Regulation amending Regulation 726/2004 54
3.5 References 55
4. Significance of generics market 57
4.1 Summary 57
4.2 Global animal health market 58
4.3 Global animal health market for generic veterinary pharmaceuticals 59
4.4 Generics in the pharmaceuticals market 61
4.4.1 Human pharmaceuticals market 61
4.4.2 Veterinary pharmaceuticals market 62
4.4.3 Reasons for differences between the two markets 64
4.5 Generics in the biologicals market 65
4.6 Generics in the medicated feed additives market 65
4.7 Distribution 66
4.8 Factors favoring generic production 67
4.9 Regional markets 67
4.9.1 EU 69
4.9.2 US 70
4.9.2.1 Background 70
4.9.2.2 US FDA approvals 70
4.9.2.3 Companion animal market 72
4.9.3 Brazil 73
4.9.4 China 74
4.10 Future trends 76
4.11 References 77
5. Strategies for R&D companies 83
5.1 Summary 83
5.2 Introduction 83
5.3 Protecting existing IPR 85
5.3.1 Patents 85
5.3.2 Trademarks 86
5.3.3 Data protection 87
5.4 Developing related patents 88
5.4.1 Improved manufacturing processes 89
5.4.2 Improved formulations and delivery methods 89
5.4.2.1 Background 89
5.4.2.2 Types of innovative delivery 91
5.4.2.3 Slow-release bolus delivery 92
5.4.2.4 Implants 92
5.4.2.5 Extended/controlled release injections 93
5.4.2.6 Higher dosing 93
5.4.2.7 Rapidly disintegrating tablets 94
5.4.2.8 Lingual spray 95
5.4.2.9 Pour-on and spot-on delivery products 95
5.4.2.10 Dermal treatments for companion animals 96
5.4.3 Combining AIs 96
5.5 Acquisition 97
5.6 Marketing strategies 97
5.6.1 Lifecycle management 97
5.6.2 Promoting the brand name 99
5.6.3 Competing on quality 101
5.6.4 Competing on price 101
5.7 Distribution issues 102
5.8 Manufacturing issues 102
5.9 Parallel trade and its effects on generics 102
5.10 Focus of R&D companies 103
5.11 References 104
6. Strategies for generics companies 109
6.1 Summary 109
6.2 Changing image of generics 109
6.3 Pricing 110
6.4 Types of generics companies 111
6.4.1 R&D companies 111
6.4.1.1 Ivermectin 112
6.4.1.2 Fipronil 114
6.4.2 Manufacturers of generic bulk materials 116
6.4.3 Generic product traders 118
6.4.4 Generics formulators 118
6.4.5 Contract manufacturing 119
6.4.6 Wholesalers and distributors 120
6.4.7 Generic human pharmaceutical specialists 121
6.5 Branded generics 122
6.6 References 124
7. Company profiles 127
7.1 Bayer Animal Health 127
7.1.1 Background 127
7.1.2 Products 127
7.1.2.1 Overview 127
7.1.3 Strategy 128
7.1.3.1 Imidacloprid 128
7.1.3.2 Baytril (enrofloxacin) 133
7.1.3.3 Acquisition of Teva's animal health business 134
7.2 Bimeda 135
7.2.1 Background 135
7.2.2 Products 135
7.2.3 Strategy 135
7.2.3.1 Global focus 135
7.2.3.2 Acquisitions 136
7.2.3.3 Manufacturing 138
7.3 Boehringer Ingelheim 139
7.3.1 Background 139
7.3.2 Products 140
7.3.3 Strategy 141
7.3.3.1 R&D investment 141
7.3.3.2 Vaccines 141
7.3.3.3 Pharmaceuticals 142
7.3.3.4 Product lifecycle management 142
7.3.3.5 Future direction 147
7.4 Ceva Santé Animale 147
7.4.1 Background 147
7.4.2 Products 148
7.4.2.1 Background 148
7.4.3 Strategy 149
7.4.3.1 Formulations 149
7.4.3.2 Packaging 149
7.4.3.3 Applicators 149
7.4.3.4 Distribution 149
7.4.3.5 Recent patents 150
7.4.3.6 US 151
7.5 Dechra Pharmaceuticals 151
7.5.1 Background 151
7.5.1.1 EU Pharmaceuticals 151
7.5.1.2 North America Pharmaceuticals 152
7.5.2 Products 152
7.5.2.1 Overview 152
7.5.2.2 Putney products 155
7.5.3 Strategy 155
7.5.3.1 Expansion plans 155
7.5.3.2 Company acquisitions 156
7.5.3.3 Antibiotics 157
7.6 Elanco 158
7.6.1 Background 158
7.6.2 Products 158
7.6.2.1 Overview 158
7.6.3 Strategy 160
7.6.3.1 Research 160
7.6.3.2 Tylan (tylosin) 160
7.6.3.3 Acquisitions 161
7.7 Huvepharma 162
7.7.1 Background 162
7.7.2 Products 163
7.7.2.1 Overview 163
7.7.3 Strategy 164
7.7.3.1 Manufacturing 164
7.7.3.2 Acquisitions 165
7.7.3.3 US market 165
7.8 Merck 166
7.8.1 Background 166
7.8.2 Products 166
7.8.2.1 Overview 166
7.8.3 Strategy 168
7.8.3.1 R&D focus 168
7.8.3.2 Acquisition focus 169
7.8.3.3 Patents 169
7.8.3.4 Zilmax (zilpaterol hydrochloride) 170
7.8.3.5 Engagement with veterinarians, livestock producers and consumers 172
7.8.3.6 Generics competition 172
7.9 Norbrook 173
7.9.1 Background 173
7.9.2 Products 173
7.9.2.1 Overview 173
7.9.3 Strategy 174
7.9.3.1 Innovation 174
7.9.3.2 Enroflox 100 (enrofloxacin) 176
7.9.3.3 Partnerships 176
7.9.3.4 Capital investment 177
7.10 Perrigo 177
7.10.1 Background 177
7.10.2 Products 178
7.10.3 Strategy 179
7.10.3.1 Product development 179
7.10.3.2 Product promotion 179
7.10.3.3 Fipronil and methoprene 180
7.11 Vetoquinol 181
7.11.1 Background 181
7.11.2 Products 181
7.11.2.1 Overview 181
7.11.3 Strategy 183
7.11.3.1 Sales and marketing initiatives geared to reference products 183
7.11.3.2 Product launches 183
7.11.3.3 Lifecycle management 183
7.11.3.4 Acquisitions 185
7.11.3.5 Agreements with other companies 185
7.12 Zoetis 186
7.12.1 Background 186
7.12.2 Products 186
7.12.2.1 Overview 186
7.12.2.2 Antibiotics 188
7.12.2.3 Competition from generics products 189
7.12.2.4 Rimadyl (carprofen) 189
7.12.3 Strategy 190
7.12.3.1 Intellectual property 190
7.12.3.2 Product lifecycle management 191
7.12.3.3 Moving away from low-margin, older products 193
7.12.3.4 Sales and marketing 193
7.12.3.5 Moving into new areas 194
7.12.3.6 Developing selected generics 195
7.13 References 196
7.13.1 Bayer 196
7.13.2 Bimeda 198
7.13.3 Boehringer Ingelheim 199
7.13.4 Ceva 203
7.13.5 Dechra Pharmaceuticals 204
7.13.6 Elanco 206
7.13.7 Huvepharma 208
7.13.8 Merck Animal Health 210
7.13.9 Norbrook 212
7.13.10 Perrigo 214
7.13.11 Vetoquinol 215
7.13.12 Zoetis 217
8. Industry associations 221
8.1 EGGVP 221
8.2 GADA (US) 222
9. Abbreviations 225

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Tags:Animal Health, Generics, Animal Pharma
Industry:Health
Location:Boston - Massachusetts - United States
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