文档介绍：中美仿制药研发和申报流程
涂家生， Ph. D.
中国药科大学药剂学教授
Tel: 025-83271305
郑州
我国仿制药申报、审评和研发对策
主要内容
中美关于原研药和仿制vities available for 505(b)(2) products
NCE Exclusivity (5 years)
New Product Exclusivity (3 years)
Orphan Drug Exclusivity (7 years)
Pediatric exclusivity extensions (6 months)
Patent Issues
505(b)(2) drugs can have Orange Book-listed patents, and enjoy 30-month stay protection against generic competitors
But, 505(b)(2) NDAs may also be blocked by patents on Reference Drugs
505(b)(2)新药的成功例子
NCE
Thalomid® (thalidomide) (1998)
Marketed unapproved drugs
Levothyroxine (2000)
Guaifenesin extended release (2002)
Quinine sulfate (2005)
New Dosage Form
Tramadol orally disintegrating tablets (2005)
Ondansetron oral spray (filed 2006)
505(b)(2)新药的例子
New Dosing Regimen
Tramadol extended release tablets (2005)
New Strength/Formulation
Antara (micronized fenofibrate caps) (2004) (130 mg is BE to Tricor 200 mg)
New Formulation/Inactive Ingredient
Avita (tretinoin gel) (new emollient) (1998)
Abraxane (cremaphor-free paclitaxel) (2005)
Oxy-ADF (oxycodone formulated to reduce drug abuse) (in development)
505(b)(2)新药的例子
New Active Ingredient
Pexeva (paroxetine mesylate) (new salt) (2003)
New Route of Administration
Emezine (prochlorperazine) (new buccal/transmucosal delivery) (NDA pending)
Oral amphotericin-B (pre-clinical)
RxOTC Switch
Alavert (loratadine) (2002)
505(b)(2)新药的例子
“Generic Biologics”
Omnitrope (rHGH) (2006)
Glucagen (glucagon recombinant) (1998)
Hyaluronidase (various approvals 2004-05)
Fortical (calcitonin salmon recombinant) (2005)
* Examples based on publicly available information
FDA NDA 审评过程
FDA 可以使用已有数据用于审评NDA吗？
Hatch-Waxman之前,国会限制 FDA在审评 NDA X时应用 NDA Y的数据：“No data in an NDA can be utilized to support another NDA without express permission of the original NDA holder.”[FDA “Finkel Memorandum” (1978, 1981)]
Hatch-Waxman 解除只适合 ANDAs：ANDA process allows “generic producer of the fully tested drug to rely on the safety and efficacy d