anda n part 4

8/3/2019 anda n part 4

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ANDA


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What are

Generics ?


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Generics are

brandedDrugs

approved byFDA.


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A generic is a drug defined as "a drugproduct that is comparable tobrand/reference listed drug product

in dosage form, strength, route ofadministration, quality andperformance characteristics, and

intended use.
http://en.wikipedia.org/wiki/Medicationhttp://en.wikipedia.org/wiki/Medication


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It has also beendefined as a termreferring to any

drug marketedunder its chemicalname without

advertising.


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According to the U.S. Food and Drug

Administration (FDA), generic drugs areidentical or within an acceptable bioequivalent

range to the brand name counterpart with

respect to pharmacokinetic and

pharmacodynamic properties. By extension,therefore, generics are considered (by the FDA)

identical in dose, strength, route of

administration, safety, efficacy, and intended

use.The FDA's use of the word identical is very

much a legal interpretation, and is not literal.
http://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Bioequivalencehttp://en.wikipedia.org/wiki/Brandhttp://en.wikipedia.org/wiki/Pharmacokineticshttp://en.wikipedia.org/wiki/Pharmacodynamicshttp://en.wikipedia.org/wiki/Statutory_interpretationhttp://en.wikipedia.org/wiki/Statutory_interpretationhttp://en.wikipedia.org/wiki/Pharmacodynamicshttp://en.wikipedia.org/wiki/Pharmacokineticshttp://en.wikipedia.org/wiki/Brandhttp://en.wikipedia.org/wiki/Bioequivalencehttp://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administration


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ECONOMICS


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When a

Generic Drug

can be

produced ?


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When a pharmaceutical company first

markets a drug, it is usually under a patentthat, until it expires, allows only the

pharmaceutical company that developedthe drug to sell it. Generic drugs can be

produced without patent infringement fordrugs where: 1) the patent has expired, 2)the generic company certifies the brand

company's patents are either invalid,unenforceable or will not be infringed, 3) for

drugs which have never held patents, or 4)in countries where the drug does not have

current patent protection.
http://en.wikipedia.org/wiki/Patenthttp://en.wikipedia.org/wiki/Patent


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WHAT IS ANDA

?

WHAT IS ANDA

FILING ?


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Abbreviated

NewDrug

Application


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An Abbreviated New Drug Application (ANDA) contains data

which when submitted to FDA's Center for Drug Evaluation

and Research, Office of Generic Drugs, provides for thereview and ultimate approval of a generic drug product.

Once approved, an applicant may manufacture and market

the generic drug product to provide a safe, effective, low

cost alternative to the American public.

A generic drug product is one that is comparable to an

innovator drug product in dosage form, strength, route of

administration, quality, performance characteristics and

intended use. All approved products, both innovator and

generic, are listed in FDA'sApproved Drug Products withTherapeutic Equivalence Evaluations
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfmhttp://www.accessdata.fda.gov/scripts/cder/ob/default.cfmhttp://www.accessdata.fda.gov/scripts/cder/ob/default.cfmhttp://www.accessdata.fda.gov/scripts/cder/ob/default.cfm


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Why it is

termed

Abbreviated ?


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Generic drug applications are termed "abbreviated"because they are generally not required to includepreclinical (animal) and clinical (human) data toestablish safety and effectiveness. Instead, genericapplicants must scientifically demonstrate that theirproduct is bioequivalent (i.e., performs in the samemanner as the innovator drug).


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A generic drug has similar effects in

terms of its rate and extent of absorptionof an approved product, which has to be

proved by the generic company. In other

words the generic drug has similar effectsin curing a disease as the approved

product. The generic approval process is

called Abbreviated New drug Application(ANDA)


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While filing an ANDA, the generic company

has to choose one of the following four

options (referred to as paras)Para I - The drug has not been patented

Para II - The patent for the drug has

already expired

Para III - The patent for the productexists but the generic company wants to

enter the markets after the date of patent

expiry passes.

Para IV - Patent is not infringed upon or

is invalid


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In case of Para I and Para II filing, once

the application is deemed complete, itis simply processed for approval. Incase of Para III the application isprocessed for approval, however itsapproval status depends upon theproducts patent expiry. ApparentlyPara IV filings are the most lucrative,

tedious, time consuming andexpensive of the above.


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In a Para III filing the companyacknowledges the patent of theapproved drug and intends to

enter the market after the patentfor the approved product expiresand there exists a scenario of

falling prices for the drug.


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In Para IV filing the company claims that thegeneric product of the company does notinfringe upon the existing patent or thepatent of the branded product is invalid andthe company strives to win an exclusivity of

180 days during which the margins for theproduct are very high. For instance, recently Dr.Reddy's filed an application with the US FDA to marketa generic form of Eli Lilly's schizophrenia drugOlanzapine in the United States.


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In all the generic filings,the FDA has 180 days to

deem the generic

application completeand accept it for review,or incomplete and reject

for filing.


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What is the significance of ANDAfiling by a PharmaceuticalCompany?


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Best AnswerSome drug formulations contain the same active compound as an

earlier approved drug; these are the so-called generic drugs.

Manufacturers of these types of drugs can request expedited FDAapproval by filing an Abbreviated New Drug Application (ANDA).

Under this filing, the evidence of safety and efficacy submitted to the

FDA in connection with the previous "brand name" drug is used to

help establish the safety and efficacy of the new drug. However, the

FDC Act requires the ANDA to include a patent certification

statement listing each patent that claims the drug or which claims a

use for the drug. The ANDA applicant may rely on the information

provided in the Orange Book for the certification statement.

Specifically, the ANDA must include one of the following statements:

Such patent information has not been filed.

Such patent has expired.Such patent will expire on a particular date.

Such patent is invalid or will not be infringed by the manufacture,

use, or sale of the drug for which approval is being sought.


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What is P IV

ANDA ?


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ANDA Paragraph- IV:Patent is invalid and willnot be infringed by themanufacture, use or saleof the generic drug


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Para-IV Filing and its Procedure-- ANDA application files the application to USFDA for

ANDA paragraph- IV certification.- Applicant has to notify the patent holder within 20days of ANDA application.- If patentee files infringement suit against ANDAapplicant with 45 days from receiving of notification inthe court, litigation starts in court.- When court gets the infringement suit, gives 30months stay to FDA for approval of the ANDAapplication, otherwise FDA can approve or dis

approve the application; no stay would be given tothe FDA.- If Court decision in respect to ANDA applicant,applicant gets the 180 days market exclusivity, or if not,

then ANDA can submit application in Para-II/III.
http://www.fda.gov/http://www.fda.gov/http://www.fda.gov/http://www.fda.gov/


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- If patentee files infringement suit in court against the ANDAapplicant as a result of the paragraph IV filing, 30 month staywould be given to the FDA by the court.- FDA is banded from approving the application for 30months.

- Or until court holds that the patent is invalid or would notbe infringed, FDA can approve the ANDA application.- If the court gives decision in favor of patentee, FDA will notapprove ANDA.- Once 30 months have passed, allows the FDA to approve

the ANDA application, even though litigation is ongoing andafter approval both parties can market their product untilthe decision would be given by the court with in the patentexpiration period.


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- A reward for challenging a patent associatedwith an approved pharmaceutical is 180 daysmarket exclusivity

- In this exclusivity period, no one other than ANDAapplicant can market the product for 180 days.- It is the strategy, which can be used by theANDA applicant to hold the complete market in

hand for the 180 days.- When this kind of application is done, sometimesoutside the court settlement may happen.


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- Agreement of settlement between Patent holderand generic producer outside the court can behappened.- In this both parties withdraw their files meanswithdrawal of ANDA application and withdrawal ofinfringement suit form the court in reward of royaltyor other provision.- The Federal Trade Commission watches this kind ofissues and if found, suites against both parties with

charging them as anticompetitive behavior inmarket.


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- 180 days generic exclusivity period iscommenced in one of two ways: either

(1) when the generic manufacturercommences commercial marketing of its drug, incase of decision before 30 month stay periodovers, or

(2) when a court decision finds the NDAholders patent invalid or not infringed, after 30months stay peroid overs or which is earlier.


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Indeed, most, if not all, generic companies havemade the Paragraph IV certification a routinepart of doing business. For example, at the start

of 2003, Teva Pharmaceutical Industries Ltd, oneof the largest generic companies in terms ofsales, had 61 product registrations currentlypending with the Food and Drug Administration

(FDA), 41 of which the company filed under aParagraph IV certification.When reviewing the timing of these filings, itappears that the Paragraph IV certifications areon the rise. A sample of three companies active

in filing certificationsBarr Laboratories, AndrxCorporation, and Impax Laboratoriesshowsthat the generic companies appear to be morewilling to file Abbreviated New Drug Applications

(ANDA) with Paragraph IV certifications


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anda n part 4

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