The Hatch-Waxman Act established several practices to facilitate generic drug approval and market entry while also providing incentives for brand-name drug innovation. It allows patent holders to extend drug patents to compensate for regulatory review time. It requires brand and generic drug companies to list patents in the Orange Book and allows generics to file Paragraph IV certifications challenging patents to gain early market entry. Large revenue drugs are more likely to see Paragraph IV certifications and authorized generic competition upon generic entry due to the substantial profits at stake.

1. THE HATCH-WAXMAN ACT
DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT.
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Presented by: Amit mishra
DBIPR 1804800300003
Supervisor: Dr. Sayantan Mukhopadhyay

2. 2
CONTENTS
1. Introduction
2. Patent Term Restoration
3. Orange Book Listing
4. Paragraph IV Certification
5. Paragraph IV Certifications , and Drug Market Size
6. Conclusion

3. INTRODUCTION
• THE HATCH-WAXMAN ACT WAS CREATED IN RESPONSE TO A COURT CASE CALLED ROCHE
PRODUCTS, INC. V. BOLAR PHARMACEUTICAL CO., WHICH INVOLVED A DRUG CALLED FLURAZEPAM.
ROCHE OWNED FLURAZEPAM, AND BOLAR WAS SEEKING TO SELL A COPY AFTER ROCHE’S PATENTS
EXPIRED. BOLAR WAS HOPING TO TIME THE APPROVAL WITH THE EXPIRATION OF THE PATENTS,
AND BEGAN WORK ON DRUG DEVELOPMENT ACTIVITIES.
• THE DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984, COMMONLY
KNOWN AS THE HATCH-WAXMAN ACT, ADDRESSED EACH OF THESE CONCERNS. THROUGH
AMENDMENTS TO BOTH THE PATENT LAW AND THE FOOD AND DRUG LAW, THE HATCH-WAXMAN
ACT ESTABLISHED SEVERAL PRACTICES INTENDED TO FACILITATE THE MARKETING OF GENERIC
PHARMACEUTICALS WHILE PROVIDING BRAND-NAME FIRMS WITH INCENTIVES TO INNOVATE.
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4. THE PATENT TERM RESTORATION PROVISIONS OF THE HATCH-WAXMAN ACT, 35 U.S.C. THE TERM OF A
PATENT DIRECTED TO AN FDA-REGULATED PRODUCT MAY BE EXTENDED TO COMPENSATE FOR DELAY
CAUSED BY THE FDA’S REGULATORY REVIEW.
THE LENGTH OF THE EXTENSION DEPENDS ON THE REGULATORY REVIEW PERIODS OCCURRING
AFTER THE PATENT TO BE EXTENDED HAS ISSUED.
THE AVERAGE TESTING PHASE IS BETWEEN SIX AND NINE YEARS, AND THE AVERAGE APPROVAL
PHASE IS LESS THAN TWO YEARS [20].
THERE ARE, HOWEVER, SEVERAL LIMITATIONS THAT MUST ALSO BE CONSIDERED. FIRST, THE
MAXIMUM PATENT TERM REMAINING AFTER THE DATE OF APPROVAL CANNOT EXCEED 14 YEARS
PATENT TERM EXTENSIONS MAY BE AVAILABLE TO PATENTS THAT CLAIM A PRODUCT, A METHOD OF
USING A PRODUCT, OR A METHOD OF MANUFACTURING A PRODUCT THAT IS SUBJECTED TO
REGULATORY REVIEW BY EITHER THE DEPARTMENT OF AGRICULTURE OR HEALTH AND HUMAN
SERVICES SUBJECT TO SEVERAL ADDITIONAL REQUIREMENTS [.
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Patent Term Restoration

5. MARY ANN HOLOVAC GRADUATED FROM DUQUESNE UNIVERSITY IN PITTSBURGH, PA, WITH A DEGREE
IN PHARMACY. SHE JOINED THE US FOOD AND DRUG ADMINISTRATION AS A COMMISSIONED OFFICER
IN THE US PUBLIC HEALTH SERVICE AND CURRENTLY HOLDS THE RANK OF COMMANDER. SHE WORKS
IN THE OFFICE OF GENERIC DRUGS WHERE SHE IS THE FOCAL POINT FOR PATENT AND EXCLUSIVITY.
SHE WAS INSTRUMENTAL IN THE CREATION OF THE ELECTRONIC ORANGE BOOK.
THE FDA PUBLISHES THE PATENT INFORMATION IN A BOOK TITLED APPROVED DRUG PRODUCTS WITH
THERAPEUTIC EQUIVALENCE EVALUATIONS, COMMONLY REFERRED TO AS THE “ORANGE BOOK”
BECAUSE ITS ORIGINAL COVER WAS ORANGE [76]. IN PARTICULAR, AN NDA MUST INCLUDE THE PATENT
NUMBER AND THE EXPIRATION DATE OF ANY PATENT
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Orange Book Listing

6. PARAGRAPH IV CERTIFICATION
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THE PARAGRAPH IV CERTIFICATIONS AND 180-DAY EXCLUSIVITY IN PART REFLECT
CHANGES IN THE FDA'S INTERPRETATION OF THE LAW GOVERNING THE GRANTING OF
AN 180-DAY GENERIC EXCLUSIVITY PERIOD TO THE FIRST GENERIC TO FILE A
PARAGRAPH IV CERTIFICATION, MADE IN LIGHT OF RELEVANT COURT DECISIONS. FIRST,
IN 1998, THE FDA CHANGED ITS INTERPRETATION OF ELIGIBILITY FOR 180-DAY
EXCLUSIVITY TO INCLUDE GENERIC MANUFACTURERS WHOSE PARAGRAPH IV
CERTIFICATIONS THE NDA HOLDER DID NOT SUBSEQUENTLY CHALLENGE. PRIOR TO
THAT TIME, A GENERIC MANUFACTURER HAD TO DEFEND SUCCESSFULLY ITS
PARAGRAPH IV CERTIFICATION IN COURT IN ORDER TO BE GRANTED THE 180-DAY
MARKETING EXCLUSIVITY PERIOD. SECOND, IN 2000 THE FDA BEGAN ALLOWING
GENERICS TO ENTER THE MARKET AND START THEIR 180-DAY MARKETING EXCLUSIVITY
PERIOD FOLLOWING THE FIRST FAVORABLE COURT DECISION THEY RECEIVED WITH
RESPECT TO A CHALLENGED PARAGRAPH IV CERTIFICATION.

7. PARAGRAPH IV CERTIFICATIONS , AND DRUG MARKET SIZE
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BOTH THE INCENTIVES TO FILE A PARAGRAPH IV CERTIFICATION AND TO LAUNCH AN
AUTHORIZED GENERIC VERSION OF A DRUG ARE LIKELY TO INCREASE WITH A DRUG'S
REVENUES .
A BRANDED DRUG WITH LARGE PRE GENERIC ENTRY REVENUES REPRESENTS A
GREATER PROFIT OPPORTUNITY FOR TRADITIONAL AND AUTHORIZED GENERIC
ENTRANTS. WHILE ANTICIPATED AUTHORIZED GENERIC ENTRY MAY REDUCE THE
AMOUNT OF PROFITS THAT A TRADITIONAL GENERIC COULD CAPTURE FOR THESE
LARGE REVENUE DRUGS, SUBSTANTIAL POTENTIAL GAINS FROM FILING PARAGRAPH IV
CERTIFICATIONS ARE LIKELY TO REMAIN.
DRUGS EXPERIENCING AUTHORIZED GENERIC ENTRY ARE TYPICALLY HIGH REVENUE
DRUGS, AND THESE LARGE REVENUE DRUGS ARE ALSO LIKELY TO EXPERIENCE
PARAGRAPH IV CERTIFICATIONS FROM MULTIPLE GENERIC MANUFACTURERS .

8. CONTACT US
CONCLUSION
The authorized generic activity is focused on relatively
large revenue drugs. The potential gains from the 180-
day marketing exclusivity period for these large revenue
drugs are likely substantial. Even when anticipated
authorized generic entry negatively impacts these
expected gains, it is unlikely that it would do so to the
extent necessary to deter all generic manufacturers from
filing paragraph IV certifications .
amitmishrapci@gmail.com
3/13/2022
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