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21 Nov 2018

Case Study: Insight on DRL-Indivior Suboxone Patent Battle

June 2018 : DRL got the generic approval for Suboxone

Dr Reddy’ s Laboratories received approval from the USFDA for generic version of Suboxone (buprenorphine and naloxone), prescribed for opioid addiction. The product approved by the US Food and Drug Administration ( USFDA) is a therapeutic equivalent generic version of Suboxone sublingual film.
USFDA granted the approval for the strengths of 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg.

July 2018 Innovator company moves to the court.
Specialty drug maker Indivior, which British drug maker Reckitt Benckiser spun off as a separate company four years ago, approached the court and secured an immediate injunction against Dr Reddy’s from on the grounds of pending patent litigation. Indivior, the innovator of the drug, had moved an injunction motion against Dr Reddy’s to block the company from selling the generic Suboxone in the US citing a pending patent infringement litigation.

One important thing need to keep in mind that Suboxone had sales of around $786 billion in the US for the first nine months of 2018. The drug accounts for about 80 percent of Indivior’s sales. So, in other word, Indivior financial performance is quite dependant on Suboxone and it is most likely that Indivior will try to defend Suboxone patent to keep generic entry away.

At Risk Generic Launch

Dr Reddy’s won a major legal battle against Indivior in US, with an appeals court vacating preliminary injunction order of a federal court that blocked the former from selling the generic version of the opioid treatment drug Suboxone.

Analysts expect Dr Reddy’s to make around $50-75 million in rest of FY19. Dr Reddy’s had booked sales of around $10-$15 million days after its launch before it was stayed by the court.

Concept of “at-risk” generic launch:

Dr Reddy’s launched its generic buprenorphine/naloxone sublingual film or Suboxone, which is used in the treatment of opioid dependence, “at-risk” in the US after it got a final approval from the US FDA on June 15.

An “at-risk” launch of a generic drug is when a company launches the drug for sale while the patent litigation is still ongoing.

It was expected that DRL will able to clock a sale of 50-70 mn USD in remaining FY 2018.

November, 2018 

Dr. Reddy’s Laboratories said that the United States Court of Appeals for the Federal Circuit issued a decision in favour of the company concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case on US Patent No. 9,931,305.

This decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result of the ruling, Dr. Reddy’s will resume its launch activities as soon as permitted.

What could be the implication of “at-risk” launch and DRL losing the case?

If Dr. Reddy’s launched generic Suboxone in the market and then lose the case, it could be ordered to reimburse Indivior for up to three times the amount of profits the British drugmaker loses. Indivior said Nov. 1 that it lost between $12 million and $18 million for the brief period Dr. Reddy’s was on the market in July. So, while a generic company enter into “at-risk” launch, they always need to be careful and should judge and predict strategic outcome strongly. 

What next for Indivior?

Indivior will continue to vigorously pursue ongoing infringement cases against DRL to protect its Suboxone sublingual film patent portfolio. Indivior  will be evaluate the process of interpreting the ruling in its entirety and will issue a statement on its implications once this review has been completed.

Pipeline Management Planning for Indivior

It is quite likely than sooner Indivior will going to loss good chunk of revenue due to generic entry of Suboxone. Therefore, Indivior is working to promote a new opioid addiction treatment called Sublocade to compensate for loss of Suboxone revenue.

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