HATCH-WAXMAN ACT & AMENDMENTS SLIDESHARE

Hatch waxman act and amendments
orange book

1. HATCH-WAXMAN ACT & AMENDMENTS Presented By ; Vamshi Pradeep N M pharm department of pharmaceutics

2. The “Drug Price Competition and Patent Term Restoration Act” of 1984 Established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act ). In 1984 United States Federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name.

3. In order to overcome the problem an act was needed to promote generic drug and innovators. In 1984, Two American politicians Grant Hatch & Henry Arnold Waxman sponsored the Official act "The Drug Price Competition and Patent Term Restoration" since then this Act was informally known as Hatch-Waxman Act . In simple words Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

4. AIM To make available more low cost generic drugs OBJECTIVES Reducing the cost associated with the approval of a generic drug Allowing early-experimental use Compensating to the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formality Motivating the generic drug manufacturers.

5. SIGNIFICANT RESULTS DUE TO HATCH-WAXMAN ACT Prior to the Hatch and Waxman act, the generic drug manufacturer had to do the entire clinical trials. After the passage of Hatch and Waxman act the generic drug manufacturer had to only prove bioequivalence of generic drug to the innovator drug by showing that the generic drug is 80-125% bioequivalent to the innovator drug. The time and cost involved for getting the generic drug into the market was significantly reduced. Low cost quality, safe and effective generic drugs were available to the patients.

6. PROVISION Creation of section 505(j) This Section outlines the process of pharmaceutical manufacturers to file a Abbreviated New Drug Application (ANDA) for approval of generic drug manufacture. Any patent that claims a "drug" or a "method of using the drug" for which it would be reasonable to assert a claim of patent violation must be included in the NDA. On approval of NDA, FDA publishes patent information for drug in Orange Book.

7. FDA publishes patent information on approved drug products in the Orange Book On approval of NDA, FDA publishes patent information for drug in Orange Book ("Approved Drug Products with Therapeutic Equivalence Evaluations") Orange Book contains Patent No. Patent Expiry Date Type of Patent Name of Patent Owner Applicant/Agent Name

8. Orange Book provides public notice of patents. Patent Term Restoration. Allows settling of disagreements of patent prior to generic entry. The orange book is available on the internet and updated monthly.

9. Subsection of 505(j) Product type Paragraph 1 For the products for which no patent information is available in the orange book. Paragraph 2 Used for the products for which all the applicable patents are expired Paragraph 3 That the patent will expire on particular date. Paragraph 4 If applicant certifies that any used patent is invalid or will not be infringed by the generic drug. Four Types of Patent Certifications When an applicant submits an ANDA to the FDA, the applicant must certify one of four things under section 505(j)(2)(A)(vii):

10. A certification under Paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under Paragraph III indicates that the ANDA may be approved when the patent expires. A Paragraph IV certification,begins with the question of whether the listed patent is valid or invalid. When patent is not expired and the generic manufacturer intended to market its generic version then, the generic manufacturer clime that the branded drug manufacture patent is invalid or not enforceable. A company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

11. GENERIC MANUFATURERE FILED WITH P-IV GENERIC MANUFACTURER- WRITTEN NOTICE TO PATENT OWNER WITHIN 20 DAYS OF ACCEPTANCE PATENT OWNER CAN FILE A PATENT LAW SUIT (SHOULD FILE WITHIN 45 DAYS) NO ACTION BY FDA FDA DOESN'T GIVE APPROVAL TO THE GENERIC FOR A PERIOD OF 30 MONTHS. IN FAVOUR OF GENERIC MANUFACTURAR - GET 180 DAY EXCLUSIVITY In reply If filed after 45 days Filed within 45 days Court decision

12. 180 days exclusivity 180 days exclusivity means rights to sell their generic products along with branded drugs in the market. EXAMPLE- 180 day exclusivity was granted to ranbaxy and watson labotatories for marketing generic drug version of lipitor ( atorvastatine calcium).

13. THANK YOU