Discuss about PATENT SEARCH FOR EFFIENT (PRASUGREL)………………
The proprietary name is Effient and the active ingredient of this drug is called Prasugrel Hydrochloride. The tablet is taken orally. The assignee’s name is Eli Lily and Company. The drug has two strengths one is EQ 10 mg Base and the other is 5Mg Base No. 22307.
Effient of strength EQ 5MG BASE has Prasugrel Hydrochloride as the active ingredient was approved on July 10, 2009. The patent expiration date for patent number 528876 is April 14, while that for patent number 6693115 is July 3, 2021. The exclusivity expiration is July 10, 2014.
The active ingredient in EQ 10MG BASE is Prasugrel Hydrochloride in tablet form administered orally. This drug was approved in July 10, 2009. The patent expiration for Patent number 5288726 is April 14, 2017 while that of patent number 6693115 is July 3, 2021. The exclusivity expiration is July 10, 2014(FDA Orange Book, 3).
The invention for patent number 5229382 is by Chakrabarti et al, July 20 1993 from the United States Patent. They invented 2-methyl-10-(4-methyl-1-piperazinyl0-4H-thieno-[2, 3-b] (1, 5) benzodiazepine which is an acid salt. It has the pharmaceutical properties in the treatment of disorders in the central nervous system (Chakrabarti et al, 2). It has the following structure
Source: Chakrabarti et al (2)
The hydrochloride or maleate in Effient shows excellent oral absorption, metabolization into the active compound, inhibition of platelet aggregation, has low toxicity and excellent storage and handling stability in the treatment of prophlaxis (Asai et al, 1). The invented tetrahydrothienopyridine derivatives that are contained in the Effient are useful in the inhibition of blood platelet aggregation. This derivative provides treatment against embolisms and is an effective blood platelet aggregation inhibitor in a mixture with a pharmaceutically acceptable carrier (Koike et al, 3).
Structure of prasugrel hydrochloride
Source: Asai et al (2)
The original patent was 0454436- Pharmaceutical products, 2-methyl-10-(4-methyl-1-piperazinyl0-4H-thieno-[2, 3-b] (1, 5) benzodiazepine published on 30. 10. 1991 with Lily Industries Limited as the applicant and Chakrabarti Jiban Kumar et al as the inventor. This is the original patent product. This invention related to organic compounds and its use as pharmaceuticals. This product has also a patent in Europe in Britain.
The British patent 1 533235 include thieno-benzodiazepines with the following nucleus structure
Source: Koike et al (1994)
When the product goes off-patent another company that is not the original makes this product. Therefore the patent protects another competitive company from making the same generic product (Monsoon and Schoenstadt, 2010).
The first patent for the Effient is set to expire in 2012 but Eli Lily and company has exclusive rights to make the drug in the U.S until July 2014. However, other matters may rise up to interfere with this exclusivity period e.g. lawsuits or other patents for specific Effient uses (Monsoon and Schoenstadt, 2010). Effient revenue is lost to competitive generics made by other companies thus these generic competitors impact the sales of Effient negatively. Zyprexa is another product made by Lily and company in which its U.S and European patents expire in October (Wall, 1). Since Effient has not expanded for use in many groups of heart patients, Plavix its competitor generated the second highest amount of sales of any drug in the world. But Plavix’s U.S patent will expire in November and Effient will take an advantage and establish a bigger market (Wall, 1).
The life of the patent can be extended if the companies apply for its extension so long as the patent Effient goes through review by the FDA before it was marketed. This is provided in the Drug Price Competition Term Restoration Act 1984 (Axelrald, 2010)
Other competitive generics which are cheaper than Effient significantly lower down the revenues of the product since people tend to buy affordable products. The U.S Food and Drug Administration approved the use of Brilinta which is a drug made by AstraZeneca in U.K for the wide uses Plavix was approved for, thus further hindering the use of Effient (Wall, 1)
These competitive threats have led many to believe that Effient will lose its performance in the current days until when its patent life comes to an end.
Patent rights and price regulation affect new drugs that are marketed in a country (Lanjouw, 2). Some patents protect the pharmaceutical products that are manufactured by a company. Patent protect Effient product in that no other drug can be made by another company of the same generics that will affect the sales of Effient. The prices of these drugs are also regulated so that the cost of a particular drug is uniform therefore reducing competition.
The patent search for Effient is a complex task with many factors going against the process like network unavailability and so on. Despite that this is an important search in order to know the details of a particular pharmaceutical product so that on can know the product. This is particularly important for medical organization that wants to make use of a particular product.
The presence of patents in a country will greatly help in the regulation of pharmaceutical products in that country since many companies only aim at gaining profits in the expense of consumer safety and it will also protect consumers from fraud.
Asai et al. Acid addition of salts of hydropyridine derivatives. 2004. United States Patent. Print.
Koike et al. Tetrahydrothienopyridine Derivatives ,Furo and Pyrrono analogs thereof and their
preparation and uses for inhibiting blood platelet aggregation.1994. United States Patent. Print.
J.K Wall. Despite sales spike, Effient has Middling prospects. IBJ News. 2011. Web. May 9,
Kristi Monsoon and Arthur Schoenstradt. Generic Effient. MedTV. 2011. Web. May 9, 2012.
Jane Axelrald. Determination of Regulatory review period for purpose of patent extension;
Effient. Federal Register. 2010. Web. May 9, 20012.
Chakrabarti Jiban Kumar et al. 2-METHY-THIENO-BENZODIAZEPINE. United States Patent.
FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. 2012.
Web. May 9, 2012.
Jean Lanjouw. Patents, price controls and access to new drugs: how policy affects global
market entry. Berkeley. 2005. Print.
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