GLP-1受容体アゴニストに関する特許と規制上の独占権
Rasha Alhiary1,2, Aaron S Kesselheim2, Sarah Gabriele2
1School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
JAMA
|July 28, 2023
まとめ
グルカゴン類ペプチド1 (GLP-1) 受容体アゴニストの製造者は,市場保護を拡大するために特許と規制上の独占性を広く使用しています. この戦略により,平均18.3年の独占期間がもたらされ,これらの糖尿病薬のジェネリック薬の競争が遅れた.
科学分野:
- 医薬品
- 知的財産権法
- 健康 経済
背景:
- GLP-1受容体アゴニストは,2005年から2型糖尿病の治療に承認されており,需要が増加し,使用指数は拡大しています.
- これらの薬は高価であり,市場独占戦略の検討を促しています.
- 医薬品の価格とアクセシビリティを分析するには 特許と規制の独占性を理解することが重要です
研究 の 目的:
- ブランドGLP-1受容体アゴニストの製造者が特許と規制システムをどのように活用するか調査する.
- 広く使用されている糖尿病治療の市場独占を拡大するために使用される方法を決定する.
- ジェネリックの競争から保護される期間を定量化します.
主な方法:
- GLP-1受容体アゴニストに対するFDAの承認された医薬品の治療等価評価 (2005-2021) の分析.
- Google Patentsを使って特許と規制上の独占データの抽出
- 最新の特許または独占権が終了するまでの市場保護期間を計算する.
主要な成果:
- GLP-1受容体アゴニスト1人につき平均19. 5件の特許が登録され,その54%が配達装置に関連していた.
- 製造者は1つの製品につき平均3つの規制独占権を確保し,一部は承認後に追加されました.
- 市場全体の保護期間の中央値は18.3年であり,現在に至るまでジェネリック特許への挑戦は成功していません.
結論:
- ブランドGLP-1受容体アゴニストの製造者は,市場独占性を延長するために広範な特許と規制戦略を採用しています.
- これらの慣行はジェネリック薬の競争を大幅に遅らせ,これらの重要な糖尿病薬の高いコストに寄与しています.
- 特許と規制の改革は,GLP-1受容体アゴニストの適時な導入を促進し,アクセスを改善するために必要である.
関連する概念動画
Glucagon-like Receptor Agonists
358
Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...
358
Oral Hypoglycemic Agents: Glinides
188
Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively...
188
Dipeptidyl Peptidase 4 Inhibitors
212
Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a...
212
Oral Hypoglycemic Agents: α-Glucosidase Inhibitors
208
α-glucosidase inhibitors, including acarbose (Precose), miglitol (Glyset), and voglibose (Voglib) (primarily available in Asia), are drugs that control blood sugar levels by delaying the digestion of starch and disaccharides. They achieve this by inhibiting α-glucosidase enzymes in the intestine, which slow the absorption of carbohydrates in the intestine, which in turn leads to a prolonged release of the glucoregulatory hormone GLP-1 from intestinal L-cells.
Acarbose and miglitol are...
Acarbose and miglitol are...
208
G Protein-coupled Receptors
12.3K
G Protein-Coupled Receptors or GPCRs are membrane-bound receptors that transiently associate with heterotrimeric G proteins and induce an appropriate response to sensory stimuli such as light, odors, hormones, cytokines, or neurotransmitters.
GPCRs are also called heptahelical, 7TM, or serpentine receptors, and consist of seven (H1-H7) transmembrane alpha-helices that span the bilayer to form a cylindrical core. The transmembrane helices are connected by three extracellular loops and three...
GPCRs are also called heptahelical, 7TM, or serpentine receptors, and consist of seven (H1-H7) transmembrane alpha-helices that span the bilayer to form a cylindrical core. The transmembrane helices are connected by three extracellular loops and three...
12.3K
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K


