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. My girlfriend blocked me on her Instagram and I felt a lot has been going on, on her account which she doesn’t want me to know about I hired verifiedprohackers@gmail.com to help me break into her account and this hacker gave me the best without me being caught.

    ReplyDelete
  32. Lol trust me I cant be messed with by any man because anonymousmaskhat@gmail.com got me covered if you feel you can cheat on me and think I would not find out lol try it and watch me catch you red handed with anonymousmaskhat@gmail.com.

    ReplyDelete
  33. I caught my wife with the help of jeajamhacker@gmail.com cheating on me via snapchat after I found out that my wife has been a cheater I decided to run a DNA test on our child and I discovered that the child was never mine am heart broken I gave this woman all she needs took care of her I made sure she lacks nothing and yet all I get in returns is this am so grateful to you jeajamhacker@gmail.com if not for you I would have been leaving in the dark taking care of another mans child thank you.

    ReplyDelete
  34. 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.

    ReplyDelete
  35. I’m Khadi Oman, i recently got married. My wife is originally from Canada and when she moved to US she never had a credit score done. He never even had a credit card in his life. We could not put his name on our new car loan because she had no credit history and as loan manager explained to us that can increase the interest rate on the loan. I added my wife to my credit card so she can build her credit history (she could not get approved for Wal-Mart credit card by herself). So few months after, my wife blames me for her low credit score because I do have lots of debt. Although it is true I do have mortgage, home equity loan, credit card debt, school loans, medical bills and now car payment, I needed a help fixing my credit profile so my wife’s score can be raised. I contacted and hired from thehackerspro.com who turned my personal credit specialist (thehackerspro.com) who helped me fix my DUI the last time. I fed him some info and he navigated through my credit profile and erased all the negative items in there and replaced them with positive trade lines thereby increasing my wife’s score to 797. We are happy with our new credit report. they has earned our respect.
    Email:proh4ckz@protonmail.com
    Text:+1(646)948-8125
    You can trust him with your credit report.

    ReplyDelete
  36. 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.   

    ReplyDelete
  37. 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

    ReplyDelete
  38. 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@cyberservices.com or whatsapp Number: +1 213 295 1376.

    ReplyDelete
  39. 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

    ReplyDelete
  40. Have you been scammed by FAKE INVESTMENT COMPANIES, FAKE BINARY OPTIONS, FAKE FOREX TRADE? You do not need to worry anymore. We at secure2invest are a team of intellectuals that specify on Bitcoin recovery services. You might think you have lost all your chances of recovering your money from the scam company but n0 you have not. We have the right tools needed to carry out a perfect recovery. So if you need to recover your lost or stolen crypto, contact us now by visiting our website Secure2invest.com.

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  41. GET RICH WITH THE USE OF BLANK ATM CARD FROM
    (besthackersworld58@gmail.com)
    Has anyone here heard about blank ATM card? An ATM card that allows you to withdraw cash from any Atm machine in the world. No name required, no address required and no bank account required. The Atm card is already programmed to dispense cash from any Atm machine worldwide. I heard about this Atm card online but at first i didn't pay attention to it because everything seems too good to be true, but i was convinced & shocked when my friend at my place of work got the card from guarantee Atm card vendor. We both went to the ATM machine center and confirmed it really works, without delay i gave it a go. Ever since then I’ve been withdrawing $1,500 to $5000 daily from the blank ATM card & this card has really changed my life financially. I just bought an expensive car and am planning to get a house. For those interested in making quick money should contact them on: Email address : besthackersworld58@gmail.com or WhatsApp him on +1(323)-723-2568

    ReplyDelete
  42. russiancyberhackers@gmail.com am happy at your service, if not you I will never know of my wife ex boyfriend that is still in touch with my her.

    ReplyDelete
  43. I don’t care what you all think, but Everyone make Mistakes .
    I Invested my savings and lost my Wallet and Crypto, I was drowning in sadness until I got to work with this Professional hacker, MR KEL CHAMBERS.
    Following all Financial Protocol,
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    I'll recommend BARNESHACK INTEL to Everyone that would act Fast to correct their Mistakes.
    CONTACT:
    Email-: barneshack9@gmail.com OR kelchambers60@gmail.com
    Cell number-: +1 (502) 482-3528

    ReplyDelete