FDA的橙皮书大名鼎鼎，是美国医药专利链接制度的重要组成，可惜我还没有好好研究过，正好做一个研究，写在下面，与大家共享。
橙皮书的正式名称是：APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS（通过等效性评估获得批准的药物），收录的是美国FDA根据安全与有效原则收录的所有批准药物，包括新药、仿制药，每年一本，每月进行更新和增补。今年已经是第26版。可见该制度已经执行了26年了，倒推下来，1980年应该是执行橙皮书制度的第1年。
电子版橙皮书可通过五个入口进行检索：
Search by Active Ingredient 活性成分检索
Search by Applicant Holder 申请人检索
Search by Proprietary Name 商品名检索
Search by Application Number 申请号检索
Search by Patent 专利号检索
点击进入后，还可选择Rx (Prescription Drug Products)处方药、OTC (Over-the-Counter Drug Products)非处方药、 Disc (Discontinued Drug Products)停用药进行检索。
比如我们以活性成分Tacrolimus（他克莫司）通过 Search by Active Ingredient选择Rx进行检索，结果如下：
Active Ingredient Search Results from “OB_Rx” table for query on “tacrolimus.”
| 050708 | No | TACROLIMUS | CAPSULE; ORAL | EQ 0.5MG BASE | PROGRAF | ASTELLAS | |||||
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| 050708 | No | TACROLIMUS | CAPSULE; ORAL | EQ 1MG BASE | PROGRAF | ASTELLAS | |||||
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| 050708 | Yes | TACROLIMUS | CAPSULE; ORAL | EQ 5MG BASE | PROGRAF | ASTELLAS | |||||
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| 050709 | Yes | TACROLIMUS | INJECTABLE; INJECTION | EQ 5MG BASE/ML | PROGRAF | ASTELLAS | |||||
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| 050777 | No | TACROLIMUS | OINTMENT; TOPICAL | 0.03% | PROTOPIC | ASTELLAS | |||||
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| 050777 | Yes | TACROLIMUS | OINTMENT; TOPICAL | 0.1% | PROTOPIC | ASTELLAS | |||||
再点击相应的申请号，比如050708,便获得该申请号药品的相关申请信息，如下：
| Active Ingredient: | TACROLIMUS |
| Dosage Form;Route: | CAPSULE; ORAL |
| Proprietary Name: | PROGRAF |
| Applicant: | ASTELLAS |
| Strength: | EQ 1MG BASE |
| Application Number: | 050708 |
| Product Number: | 001 |
| Approval Date: | Apr 8, 1994 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | TACROLIMUS |
| Dosage Form;Route: | CAPSULE; ORAL |
| Proprietary Name: | PROGRAF |
| Applicant: | ASTELLAS |
| Strength: | EQ 5MG BASE |
| Application Number: | 050708 |
| Product Number: | 002 |
| Approval Date: | Apr 8, 1994 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | TACROLIMUS |
| Dosage Form;Route: | CAPSULE; ORAL |
| Proprietary Name: | PROGRAF |
| Applicant: | ASTELLAS |
| Strength: | EQ 0.5MG BASE |
| Application Number: | 050708 |
| Product Number: | 003 |
| Approval Date: | Aug 24, 1998 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| Patent and Exclusivity Info for this product: | View |
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需要看专利和独占期情况，点击上面的View，如下：
Patent Data
There are no unexpired patents for this product in the Orange Book Database.
[Note: Title I of the 1984 Amendments does not apply to drug products submitted or approved under the former Section 507 of the Federal Food, Drug and Cosmetic Act (antibiotic products). Drug products of this category will not have patents listed.]
Exclusivity Data
| 050708 | 001 | ODE | MAR 29,2013 |
可得知该药物专利不适用于1984年修订的Hatch-Waxman法案，但因为该药物为孤儿药（ODE），获得市场独占保护，保护期到2013年3月29日终止。
学习到这里，不明白了，为啥保护期这样长？孤儿药的市场独占期应该是7年呀。奇怪。