After Patent Life, FDA says NO to Generic OxyContin

Under the Food, Drug, & Cosmetic (FD&C) Act and implementing regulations, the Food and Drug Administration (FDA) is responsible for ensuring that all new drugs are safe and effective. FDA also regulates the advertising and promotion of prescription drugs under the FD&C Act.

Purdue Pharma L.P., based in Stamford, CT, is a privately held pharmaceutical company founded by physicians. The FDA approved Purdue Pharma’s controlled-release pain reliever OxyContin in 1995. OxyContin (oxycodone hydrochloride controlled-release) is an opioid analgesic supplied in various dosages for oral administration. OxyContin is Purdue’s brand for time-release oral oxycodone. OxyContin followed Purdue’s older product, MS Contin, a morphine-based product that was approved in 1984 for a similar intensity and duration of pain and during its early years of marketing was promoted for the treatment of cancer pain.

OxyContin’s time-release formula could be used over 12 hours to maintain a steady level of the narcotic oxycodone in patent law firm suffering from moderate-to-severe pain. By 2001, sales had exceeded $1 billion annually, and OxyContin had become the most prescribed brand name narcotic medication for treating moderate-to-severe pain. OxyContin has long been one of the nation’s top-selling prescription painkillers with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.

However, in early 2000, reports began to surface about abuse and diversion for illicit use of OxyContin. Several factors thought to be early contributors to the abuse and diversion of OxyContin are: 1) the active ingredient in OxyContin is twice as potent as morphine, which may have made it an attractive target for misuse; 2) the original label’s safety warning advising patients not to crush the tablets because of the possible rapid release of a potentially toxic amount of oxycodone may have inadvertently alerted abusers to methods for abuse; and, 3) the significant increase in OxyContin’s availability in the marketplace may have increased opportunities to obtain the drug illicitly in some states.

After the problems with often-abused OxyContin began to surface, FDA and Purdue collaborated on a risk management plan to help detect and prevent abuse and diversion. Although risk management plans were not in use when OxyContin was approved, they are now an optional (or, at times, required) feature of new drug applications.

Recent Developments

Purdue stopped making its classic OxyContin pills — first released to the market in 1995 and easy to crush, snort and abuse — in 2010. In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Purdue stopped shipping original OxyContin to pharmacies in August 2010. Various sources estimate that this new ‘tamper-proof’ pill’s patent term will expire about 2025.

Purdue Pharma’s patent on its original OxyContin formulation expired on April 16, 2013. That very same day, the FDA issued an immediate press release stating that it will not approve generic formulations to the original OxyContin. The FDA says that:

“because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an
increased potential for certain types of abuse, the FDA has determined that the benefits of original
OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug
applications (generics) that rely upon the approval of original OxyContin.”

The FDA also approved updated labeling for Purdue’s reformulated OxyContin tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

The decision is the first time that the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton. Dr. Throckmorton further stated that the F.D.A. had looked at data from several studies, some of it underwritten by Purdue, in arriving at its decision. He said that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.

Resource Byhttps://sewellnylaw.com/after-patent-life-fda-says-no-to-generic-oxycontin/

Advertisements

About sewellnylaw

Mr. Sewell continuously distinguishes himself as a top litigation attorney. He has twice been selected by New York Super Lawyers as a "Rising Star". Additionally, he is recognized as "Superb" and a "Top Litigation Attorney" by the lawyer-rating service Avvo. Moreover, he has been prominently featured as a preeminent legal authority on CNN. Attorney Sewell has several years of transactional experience as well as significant, state and federal litigation practice. Moreover, he is well-versed in prosecution matters before the United States Patent & Trademark Office and the United States Copyright Office. He has represented the spectrum of patent, trademark, and copyright owners, food and drug companies, business owners, non-institutional clients, and more. While at a top 100 law firm, Mr. Sewell's foci were in the areas of litigation and intellectual property. Prior to large firm practice, he honed his skills in Manhattan at a litigation boutique that specialized in intellectual property, food & drug law, and litigation. Mr. Sewell is also an alumnus of the distinguished Innocence Project at the Benjamin N. Cardozo School of Law. He drafted motions and briefs regarding reopening criminal cases and reversing convictions using DNA evidence. Ultimately, his efforts culminated in the exoneration of one of his clients. Dayrel also completed a legal internship at Bristol-Myers Squibb Company. While at Bristol-Myers, he gained patent litigation and prosecution experience through the Court of Appeals for the Federal Circuit litigation and training seminars, respectively. He also worked on several regulatory matters including corporate consultant agreements, conflicts of interest, clinical trials, and co-marketed pharmaceutical contracts. To continuously expand his expertise, Attorney Sewell has several years of experience providing counsel and litigation representation to real estate entities and individuals. Mr. Sewell recognizes the systemic real estate crisis and its affects on both investors and individuals, and is well-prepared to continue to assist clients with the crisis' persistent havoc that affects the millions of people involved. Prior to law school - with academic, medical background, and practicum requirements being met - Mr. Sewell received his M.P.H. from Columbia University and was a Director for medical research studies in New York City. Dayrel received his B.A. from The Johns Hopkins University, majoring in both Natural Sciences and Public Health. Mr. Sewell has also found time to do pro bono work. Of note, Dayrel is proficient in Spanish. Some examples of Attorney Sewell's work include: Litigation involving contracts, patents, real estate, securities, foreclosures, trademarks, copyrights, licenses, LLCs, and torts Negotiating/authoring business contracts and settlement agreements issuing patent and trademark opinions drafting and registering patents, trademarks, and copyrights counseling clients regarding food & drug product registration, compliance, and other regulatory matters advising startup companies and creating their business entity structure real estate transactions (i.e., conveyances, leases, title searches, deeds, assignments, recordings, etc.) Bar admissions United States Supreme Court New York District of Columbia United States Patent Bar United States Court of Appeals for the Second Circuit United States Court of Appeals for the Federal Circuit United States District Court for the Southern District of New York United States District Court for the Eastern District of New York Degrees J.D., Benjamin N. Cardozo School of Law M.P.H., Columbia University B.A., The Johns Hopkins University Awards & Distinctions Two-time Super Lawyers NYC Metro Rising Star Who's Who in American Law Notes Editor, Cardozo Journal of Law & Gender Alumnus, The Innocence Project, Benjamin N. Cardozo School of Law NIEHS Community & Preventive Medicine Fellow, Mount Sinai School of Medicine Recipient, Phoenix Fellowship, Columbia University Alumnus, Council on Legal Education Opportunity Winner, Black Bar Association of Bronx County Writing Competition Federal Acquisition Regulations Certificate HIPAA Research Compliance Certificate Publications Dayrel S. Sewell, Amulya Appalaraju, The Duality of the U.S. Supreme Court's Janus Decision, American Bar Association, Securities Litigation, 2015 Fall Newsletter. Dayrel S. Sewell, Andrew Fine, The "Redskins" Trademark: Turn-over on Downs, IPFrontline, October 2015. Dayrel S. Sewell, Ivan Ng, Pharrell Williams and Robin Thicke told they "Got To Give It Up", IPFrontline, May 2015. Dayrel S. Sewell, Ivan Ng, A ?Generic' Victory for Specific Fact-Findings, Intellectual Property Today, March 2015, at 34. Dayrel S. Sewell, Ivan Ng, A ?Generic' Victory for Specific Fact-Findings, IPFrontline, February 2015. Dayrel S. Sewell, Myriad Back in Court on Patent Subject Matter Eligibility, The Brooklyn Barrister, January/February 2015, at 9. Dayrel S. Sewell, The Ignominious Patent Troll, The Brooklyn Barrister, November 2013, at 5. Dayrel S. Sewell, The Ignominious Patent Troll, Intellectual Property Today, November 2013, at 12. Dayrel S. Sewell, Unanimous U.S. Supreme Court and Angelina Jolie: BRCA1 & BRCA2 Patentability, Intellectual Property Today, July 2013, at 24. Dayrel S. Sewell, Marc S. Ullman, The Regulation of Advertising for Dietary Supplements in the United States, KENKO SANGYO RYUTSU SHIMBUN (Health Trade Newspaper), April 8, 2007, at Issue 661. Tam T. Nguyen, Dayrel S. Sewell and Adrian S. Dobs. Oral Methyltestosterone Given to Post-menopausal Women Decreases Adipose Tissue and Increases Lean Muscle Mass with No Change in Muscle Strength. ENDO 2000 Abstracts. Category: Clinical Science: Aging. Medicine, Johns Hopkins University (2000). Speaking Engagements Dayrel S. Sewell, Brooklyn Bar Association Continuing Legal Education Speaker, Intellectual Property Fundamentals: What Every Attorney Needs to Know, May 2014. Dayrel S. Sewell, Legal Analyst (en espa?ol ), CNN "Realidades En Contexto": Nueva Jersey Agentes Inmobiliarios haber supuestamente Relaciones repetidas Dentro de una casa en venta, March 2014. Dayrel S. Sewell, Panelist, Managing Career Changes in a Changing Global Market, Union League Club, November 2013. Dayrel S. Sewell, Presenter, Professional Development, Bristol-Myers Squibb Legal Department Conference, June 2009. Other Licenses New York State Real Estate Broker New York State Notary Public Organizations Brooklyn Bar Association Vice-Chair, Intellectual Property Committee Vice-Chair, Real Property Committee New York County Lawyers' Association The Johns Hopkins University Law Affinity Committee
This entry was posted in Business and Corporate Law, Law, Lawyers and Law Firms, Services and tagged , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s