Adderall IR; Adderall XR: Are they from Shire, Barr, Teva, or Ranbaxy?

Armand Rossetti

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Adderall is in the news today. Barr Laboratories (Barr) recalled lot #311756 of the powerful psychostimulant, indicating that consumers might receive exceedingly potent dosages due to oversized tablets.

To get a better idea of the complex under currents in Big Pharma, let’s discuss the pharmaceutical giant,Teva, a player by acquisition in the Adderall recall:

For 7.5 billion dollars, Israeli drug giant, Teva Pharmaceutical Industries (now the world’s largest generic drug manufacturer) acquired Barr Laboratories in 2008. Barr currently owns intellectual property rights to Adderall.

The average consumer might not be familiar with Teva as a drug manufacturer. However, due to numerous acquisitions and joint ventures, Teva is huge. As a result, the giant generic pharmaceutical concern has become the utmost patent copycat pharmaceutical player on the international scene.

Here are several examples of Teva’s acquisitions and agreements:

Teva and India’s largest generic drug manufacturer, Ranbaxy, reached an agreement in 2004 for Teva to ship its Quinapril HCL tablets.

In 2008, Teva and the Japanese generic firm, Kowa partnered for a 50-50 stake in Teva-Kowa, which would become a leading generic producer in Japan.

In January of 2009, Teva and Swiss based Lonza Group formed a joint venture to manufacture and market a portfolio of “biosimilars.”

On June 29, 2009, Teva and its partner, Antares, announced the introduction of a needle-free injector product.

Teva plans to spend another billion dollars to acquire Indian drug companies and to set up Greenfield manufacturing facilities.

In March of 2009 Stem-Ex, Gamida Cell-Teva joint venture product received the European Union’s orphan drug equivalent.

In fact, Teva is not afraid to challenge any drug company for the right to make generic copies of drugs. For example, Teva has challenged and prevailed over Novartis, concerning the right to manufacture a generic copy of Lotrel, even though Novartis’ patent is valid until 2017.

Win a few and lose a few.

In 2008, The Court of Appeals for the Federal District of New York ruled in favor of TAP Pharmaceutical in its quest to prevent Teva from infringing TAP’s patent for Prevacid.

The Barr-Shire Connection:

Last year, Teva acquired Barr, but not before Barr acquired Shire, plc’s intellectual property rights to Adderall.

Adderall XR (extended release) is the brand name for a mixture of extended release encapsulated amphetamine salts that Shire is still manufacturing and selling, and that physicians prescribe to treat attention deficit hyperactivity disorder (ADHD).

In 2006, Shire’s worldwide sales of Adderall XR were 864 million dollars. Then Barr applied for and received an abbreviated new drug application (ANDA) from the FDA that would permit Barr to manufacture a bioequivalent generic Adderall. After Bar received its ANDA designation for Adderall, Shire sued in New York’s Federal District Court for the Southern District to protect its patent rights.

In an effort to end the intellectual property tussle in August 2006, Shire and Barr reached an agreement whereby Shire would pay Barr a net amount of up to $102 million.

The structured deal had Shire paying Barr’s subsidiary, Duramed, up to $165 million; $25 million immediately and up to $140 million over eight years, described as compensation for product development. In return, Barr agreed to pay Shire $63 million as compensation for transferring Shire’s rights to Adderall IR (immediate release) tablets.

After the parties consummated their deal, Barr retained of exclusivity eligibility regardless of the patent suit. In return, Shire agreed not to release an authorized generic for 180 days, during which time, Barr would pay Shire a royalty. Thereafter, the Adderall license would be non-exclusive and royalty-free. In addition, Barr received the rights to Shire’s Adderall IR and the opportunity to purchase an innitial supply of Adderall IR from Shire.

The settlement removed Shire’s threat via lawsuit and created a protective intellectual property bottleneck. As part of the same agreement, Barr agreed to enter the market on April 9, 2009 (a date in between the earliest point that Barr could have entered the Adderall market and the time that Shire’s patent was due to expire). See pages 133-134 of: Testimony of C. Scott Hemphill, Associate Professor, Columbia Law School before the House Committee on Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection; Hearing on H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007.

A second drug company called Impax was also on the ANDA side of the Shire-Barr patent lawsuit. Unlike Barr as first filer, Impax was a later filer and, therefore, had no eligibility for intellectual property exclusivity. As further compensation, Impax received cash for promotion of another drug.

Given the compression of competition due to the agreement, the FTC caught wind of the Shire-Barr-Impax agreement and opened an investigation in October 2006:

“The US Federal Trade Commission (‘FTC’) informed Shire on October 3, 2006 that it was reviewing the ADDERALL XR patent litigation settlement agreement between Shire and Barr Laboratories, Inc. (‘Barr’). On June 22, 2007, the Company received a civil investigative demand requesting that it provides information to the FTC relating to its settlement with Barr and its earlier settlement with Impax Laboratories, Inc. The Company is co-operating fully with this investigation and believes that the settlements are in compliance with all applicable laws.”

The Aftermath of it all:

Of course this whole intellectual property rights tussle died down, and in 2008 Teva acquired Barr, together with all of Barr’s intellectual property and manufacturing know how. But there is something else that might be important to note.

In the Adderall IR settlement, Barr agreed to provide manufacturing backup for products that might emerge from the development agreement. Right now, Shire manufactures the XR formula and Teva (through its division Barr-Duramed) manufactures the Adderall IR formula. Shire's Adderall XR formula is still patent protected until 2018. However, Duramed is free to manufacture the IR formula. And lest we forget, India’s Ranbaxy also produces a generic form of Adderall. If I recall correctly, the now Japanese owned Ranbaxy is also the company that falsified data on drug applications?

Consumer Confusion:

Internet discussion boards are replete with commentary concerning the different kinds of Adderall on the market, and the way that physicians go about prescribing that drug:

Comment #1 (orange or pink);

Comment #2 (Insurance decides and potent v. impotent);

Comment #3 (Barr or Ranbaxy); and

Comment #4 (A drug for wrong reasons).

It is pretty clear to see why something as simple as oversized pills might elude Big Pharma's quality control effort. There's probably too much wheeling and dealing taking everyone's attention off the ball; the ball being, consumer safety.