In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig.

MEMORANDUM OPINION

Goldberg, J.

Presently before me in this antitrust, multi-district litigation matter is a Motion for Partial Summary Judgment filed by Plaintiffs-a certified class of direct purchasers of Suboxone-regarding the relevant antitrust market. Plaintiffs ask that I define the relevant market to include only Suboxone and its AB-rated equivalents sold in the United States and its territories. Defendant responds that relevant market is a question of fact, not appropriate for disposition on summary judgment. I agree with Defendant and for the following reasons, will deny the Motion.

I. FACTUAL BACKGROUND

The following facts are derived from the evidence submitted by the parties in support of and in opposition to the relevant market summary judgment motion. Where there is conflicting evidence about a particular fact, Federal Rule of Civil Procedure 56 requires that I view all facts in the light most favorable to Plaintiffs, the party opposing the Motion.^[1]

A. The Antitrust Scheme

The alleged antitrust scheme at issue is multi-faceted and explained at length in my Opinion regarding the denial of Defendant's Motion for Summary Judgment on liability in In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation, 622 F.Supp.3d 22, 35-45 (E.D. Pa. 2022). I incorporate these facts by reference here.

B. Facts Related to the Relevant Market^[2]

1. Opioid Use Disorder Treatment During the Relevant Time Period

The following products have been approved for opioid use disorder:

Product	Manufacturer	Approval Date
Methadone	(numerous)	First approved 1947
Naltrexone tablets	Teva (discontinued) Barr Elite labs SpecGX LLC Accord Healthcare Sun Pharms Chartwell	October 20, 1984 May 8, 1998 May 26, 1999 March 22, 2002 August 17, 2011 February 24, 2012 July 21, 2017
Vivitrol	Alkermes, inc.	April 13, 2006
Subutex Tablets (discontinued)	Indivior/Reckitt	October 8, 2002
Suboxone Tablets (discontinued)	Indivior/Reckitt	October 8, 2002
Generic buprenorphine tablets	Hikma (f/k/a) Roxane Ethypharm Actavis Rubicon Sun Pharm. Rhodes Pharms.	October 8, 2009 September 24, 2010 February 29, 2015 June 10, 2015 January 29, 2016 March 27, 2017
Suboxone Film	Indivior/Reckitt	August 30, 2010
Generic buprenorphinenaloxone tablets	Amneal Actavis Hikma (f/k/a) Roxane Teva Ethypharm USA Corp. Sun Pharm.	February 22, 2013 February 22, 2013 June 27, 2014 September 8, 2014 October 16, 2015 August 5, 2016

Lannett Co. Inc. SpecGX LLC Wes Pharma Inc.	September 19, 2016 December 13, 2017 July 17, 2020
Zubsolv (tablets)	DJA Global Pharmaceuticals	July 3, 2013
Bunavail (film strips)	BioDelivery Sciences International	June 6, 2014
Probuphine (implantable)	Titan Pharmaceuticals, Inc.	May 26, 2016
Sublocade	Indivior	November 30, 2017
Generic buprenorphinenaloxone film	Dr. Reddy's Alvogen Sandoz (discontinued) Mylan	June 14, 2018 January 24, 2019 February 2019 April 17, 2020

(DSUF ¶ 1; PR ¶ 1.)

Methadone was the original medicine for opioid use disorder and was originally approved in 1947. Methadone remains available as a medication treatment option, but due to its high risk of abuse, it is most commonly used in a clinic setting. (Def.'s Ex. 106; Def.'s Ex. 118, Report of Dr. Kwait (“Kwait Report”); Def.'s Ex. 180.)

Vivitrol is a once-monthly injectable naltrexone product, which was approved by the FDA in April 2006. It is indicated “for the prevention of relapse to opioid dependence, following opioid detoxification,” meaning patients must be opioid free when they begin their treatment. (Def.'s Ex. 174.)

Naltrexone is an opioid antagonist indicated for “the blockage of the effects of exogenously administered opioids” as part of “an appropriate plan of management for [opioid] addition[].” Naltrexone tablets were first launched in 1980s under the brand name Revia but are now available in generic formulation. (Def.'s Exs. 181, 182.)

Subutex and its subsequent generic equivalents contain one active ingredient, buprenorphine hydrochloride. These types of medications are referred to as “monotherapy” or the “monoproduct.” Bunprenorphine-containing products address symptoms of withdrawal and can be taken on a maintenance basis. When dosed appropriately, they do not induce a euphoric effect in patients, thus

allowing patients to eliminate or reduce cravings for opioids. Buprenorphine products can be taken by patients outside the clinic setting. (Kwait Report.)

Suboxone, first approved in tablet form on October 8, 2002, is a combination product containing buprenorphine and naloxone that is “indicated for maintenance treatment of opioid dependence.” (Def.'s Ex. 129; (DSUF ¶ 6; PR ¶ 6.) Suboxone products and their generics are “combination” products, i.e. they contain both buprenorphine and naloxone. Buprenorphine and naloxone work in combination to treat opioid dependence, with buprenorphine allowing patients to reduce cravings for opioids, and naloxone deterring the reformulation of the product into an injectable preparation. (DSUF ¶ 8; PR ¶ 8.) Since the introduction of the Suboxone tablet in 2002, a number of other “combination” products have been approved by the FDA, including Suboxone film, generic Suboxone tablets, Zubsolv (brand tablet), Bunavail (brand film), and generic Suboxone film. (Def.'s Ex. 118.) The primary difference between Zubsolv and the Suboxone tablet is the bioavailability of the active ingredients. (DSUF ¶ 15; PR ¶ 15; Def.'s Ex. 160.) The difference between Bunavail and Suboxone film was that Bunavail used buccal administration (inside of the cheek), whereas Suboxone film used sublingual administration (under the tongue). In 2015, Suboxone film received FDA approval for both buccal and sublingual administration. (DSUF ¶ 19; PR ¶ 19.)

Recently, two branded buprenorphine-containing products have also been approved- Probuphine and Sublocade. Probuphine is a buprenorphine implant indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a “transmuscosal buprenorphine-containing product.” (Def.'s Ex. 177.) Sublocade is a buprenorphine injection that allows the medicine to release slowly into a patient's body and is “indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product.” (Def.'s Ex. 178.)

2. The Structure of the Opioid Dependence Drug Market

The demand for pharmaceutical drugs is “driven through a supply chain that runs (a) from healthcare providers who select drugs, (b) to pharmacy benefit managers who manage the insurance, (c) to patients who pay some or all of the cost of the prescription, (d) to the pharmacy level and treatment facilities where demand is driven by prescriptions, and (e) ending with wholesalers who seek to fill the demand of pharmacies and other intermediaries.” In re Suboxone Antitrust Litig., No. 13-md-2445, 2021 WL 662292, at *12 (E.D. Pa. 2021) (citing Ex. 1, Lamb Rep. ¶ 27). Wholesale acquisition cost (“WAC”) is the price that wholesalers pay to obtain pharmaceutical products. The amount that insured patients are responsible for paying for a prescription drug-i.e., the “co-payment”-is typically set by the insurance company. Most patients with commercial insurance pay a fixed co-pay cost for their medications depending on the drug's placement on the insurer's formulary. Patients typically pay nothing for drugs covered on Tier 1 of the formula but may be responsible for a higher co-payment for drugs on Tier 2 of the formulary, which could be offset through use of coupons or discount cards. Patients with no insurance or with insurance that does not cover a particular drug are responsible for the entire cost. (DSUF ¶ 39; PR ¶ 39.)

The choice of which medication to prescribe can hinge on insurance coverage, cost, physician preferences, or patient preferences. (DSUF ¶ 2; PR ¶ 2.) Indeed, it is common for doctors to prescribe a broad array of buprenorphine medications, including the buprenorphine monotherapy tablets such as Subutex and its generic equivalents. (Def.'s Ex. 17, Normann Rep. at Exh. E3.) Demand for treatments of opioid dependence has been growing at high rates over the years and further growth is expected. (DSUF ¶ 4; PR ¶ 4.)

II. STANDARD OF REVIEW

Federal Rule of Civil Procedure 56 states, in pertinent part:

A party may move for summary judgment, identifying each claim or defense-or the part of each claim or defense-on which summary judgment is sought. The court shall grant summary judgment if the

movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. The court should state on the record the reasons for granting or denying the motion.

Fed. R. Civ. P. 56(a). “Through summary adjudication, the court may dispose of those claims that do not present a ‘genuine dispute as to any material fact' and for which a jury trial would be an empty and unnecessary formality.” Capitol Presort Servs., LLC v. XL Health Corp., 175 F.Supp.3d 430, 433 (M.D. Pa. 2016). A factual dispute is “material” if it might affect the outcome of the suit under the applicable law. Anderson v....