Friday 30 December 2011

HATCH-WAXMAN ACT


                  


What is Hatch-Waxman act?

It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.

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)”

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.
  • Since 1984, over 10,000 generic drugs have entered the market, and generics accounted for close to 50 percent of prescriptions filled (as on august 1, 2003).
  • Billions of dollars in health care costs are being saved annually.

Patents and Exclusivity

Generic drug approval process isn’t less complicated as it involves patent and exclusivity issues. If any New Molecular Entity (NME) is approved, it is granted a exclusivity period of 5 years, which could be extended to 3 more years for supplements requiring clinical trials.

Patent Certifications

As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:
  • (I) that the required patent information relating to such patent has not been filed (Para I certification);
  • (II) that such patent has expired (Para II certification);
  • (III) that the patent will expire on a particular date (Para III certification); or
  • (IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).
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, however, begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts before the expiration of the patent. Under the current regulations, the ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge. Until the effective date of FDA’s final rule, all patents submitted and listed in the Orange Book that are the subject of a paragraph IV certification require notice to the NDA holder and patent owner. The notice must include a detailed statement of the factual and legal basis for the ANDA applicant’s opinion that the patent is not valid or will not be infringed.

The submission of an ANDA for a drug product claimed in a patent is an infringing act if the generic product is intended to be marketed before expiration of the patent. Accordingly, the ANDA applicant who submits an application containing a paragraph IV certification may be sued for patent infringement. If the NDA holder or patent owner files a patent infringement suit against the ANDA applicant within 45 days of the receipt of notice, FDA may not give final approval to the ANDA for at least 30 months from the date of that notice. This 30-month stay will delay approval of the generic drug product unless the court reaches a decision earlier in the patent infringement case or otherwise orders a longer or shorter period for the stay.

180 Day Exclusivity

The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.

The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first.

180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of  Lipitor ( Atorvastatin calcium).

Keywords: Drug price competition and patent term restoration act-1984, ANDA, generics,180 day exclusivity, 80-125% bioequivalence,  505 (b) (2) application,  Para I certification, Para II certification, Para III certification, Para IV certification.


References-

P.S.-
A generic drug product is the one, that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

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  31. Thank God for verifiedprohackers@gmail.com it was with the help of this hacker I knew my wife was planning to poison me Though have been in contact with verifiedprohackers@gmail.com for a while now and also this hacker was able to gain access to my wife iPhone 12 Pro max after we gained full control of my spouse phone for over 5 months now just yesterday I got notified right on my phone of a particular text messages my wife deleted and I was able to read her deleted text messages and I read her conversation with the man she has been planning with to kill me so that they can continue there love life without me been an obstacle verifiedprohackers@gmail.com I will never stop appreciating you, you are the best am happy my time, funds and everything was never in vain.

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  32. I'm Marian Loiuse from New York, United State, I had financial challenges during the pandemic crisis, was trying to read something online when I come across a trading forex broker site that seems very interested, I contacted them and they responded so fast so I decided to trade with the broker hoping to earn a lot of profit at the end, I started with my $3,500 US Dollar's savings and ended up paying $187,690 US dollars. All my savings and property funds were gone and more payment was needed from me until I realized it was nothing but a scam, my life was drained out of me and I was helpless at this point in time, had so much depth and pressure on me, so luckily my friend was in a mutual relationship to a very popular world hacker who then directed me to ''Wizard William Mitnick  Quick Recovery AT Programmer DOT Net''.  After reaching out to Wizard William via ''wizardWilliamMitnickquickrecovery (AT) programmer (DOT) net''  he then responded and ask me about my case and then ask me to reach him also on WhatsApp ''+1'' (559) 851/ (5537)  and I did as he instructed me. finally, my funds were recovered back to my ETH wallet within 48 hours, all thanks to Wizard William.  He was the angel that was sent to save me from death.   

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  33. Please everyone should be careful and stop being deceived by all these brokers and account managers, they scammed me over $50,000 of my investment capital, they kept on requesting extra funds before a withdrawal request can be accepted and processed, in the end, I lost all my money. All efforts to reach out to their customer support desk had declined, I found it very hard to move on. God so kind I followed a broadcast that teaches on how scammed victims can recover their funds, I contacted the email provided for consultation, I got feedback after some hours and I was asked to provide all legal details concerning my investment, I did exactly what they instructed me to do without delay, to my greatest surprise I was able to recover my money back including my profit which my capital generated. I said I will not hold this to myself but share it to the public so that all scammed victims can get their funds back. Direct WhatsApp contact: +1 (559) 851-5537

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  35. Have you been defrauded by deceptive Bitcoin traders? Or are you seeking to recover funds you lost on telegram accounts to take over hackers/rippers?. I personally will recommend no one other than Secure2invest. This is the least I could do for them after they saved my life by helping me recover up to 3.966BTC in less than two weeks from an online ripper lately. I got referred to them via my colleague at work , they also helped his spouse recover tokens and coins lost to scams .I'm glad I got in contact with this specialist because I would have most likely fallen victim to another online fraudster all in the name of them trying to help me. I owe this people a lot because it is so hard to see legit help online. Are you having similar issues with your BTC Wallet,Don't get scammed by these online fraudsters, contact Secure2invest.com ,they are the most efficient and most trusted recovery expert on here

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  42. Wizard Brixton Group of Hacker save My Marriage I was a victim of Marriage cheats from my husband without knowing he has a family outside our Marriage and has been spending my money on them I never know he was capable of such but due thou the recently way he starts sneakily around I got suspicious of him and was in need of a Hacker to spy on him without no doubt my suspicious was true. Wizard Brixton Hacker got me proof of his message and calls and the address of other families where he goes frequently if you have such a cheating partner contact him via Wizardbrixton at Gmail dot com WhatsApp : (+1- /807-23 ) 4-0428 he is a Real Wizard

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  43. I called my spouse secretary today and she told me my husband left the office already but when I called my husband he lied to me that he was still at the office which made me suspicious about him cheating, he kept on doing this and I had no option than to investigate if he is cheating or not so I hired darkhatthacker@gmail.com for a smooth phone hack to my surprise this hacker gave me all the information I wanted, granted me full access to his phone so I got to monitor his cell phone remotely without being caught all thanks to you darkhatthacker@gmail.com first time using your services all I got was the best thank you once again

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  44. I just have to introduce this hacker that I have been working with him on getting my credit score been boosted across the Equifax, TransUnion and Experian report. He made a lot of good changes on my credit report by erasing all the past eviction, bad collections and DUI off my credit report history and also increased my FICO score above 876 across my three credit bureaus report you can contatc him for all kind of hacks . Email him here via Email him here via hackintechnology@gmail.com or whatsapp Number: +1 410 635 0697.

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  52. This comment has been removed by the author.

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  53. What would I have done without your help Mr James Mckay Wizard?.. I'm most grateful and am writing a review for you with a grateful heart. Thanks for helping me get my life back together and especially helping me to clear my credit debts that my wife had maxed out and even more thanks for helping me get the proof I need to go through with the court proceeds. My wife has always been a cheater and I never would have had helped without you, she would have took away my children and all my money. If you are looking to hire a good cyber hacker and recovering agent he is the man for you contact him here: jamesmckaywizard@gmail.com or What'sapp +919863293475..

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  54. “I invested with a Crypto broker without proper research to know what I was hoarding my hard-earned money into, only to find out it was a hoax and sham. I invested over $180,000 USD estimated to be 6.3 BTC. I was unable to make any withdrawals out of my initial deposits let alone the gains he claimed I have earned even after meeting the bogus fees and charges he is always requesting. Fortunately, I got to know about Century Hacker's Bitcoin recovery programmers through research and positive reviews on Google. After a couple of hours consulting with them, all my funds were recovered including my profits. I can’t thank these guys enough for making me not another prey to these scammers. Thank you Century Hackers. Consult them via: century@cyberservices.com
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