COMMISSIONERS:
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`Docket No. C-4727
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`UNITED STATES OF AMERICA
`BEFORE THE FEDERAL TRADE COMMISSION
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`Joseph J. Simons, Chairman
`Noah Joshua Phillips
`Rohit Chopra
`Rebecca Kelly Slaughter
`Christine S. Wilson
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`In the Matter of
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`PFIZER INC.,
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`a corporation;
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`UPJOHN INC.,
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`a corporation;
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`VIATRIS INC.,
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`a corporation;
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`MYLAN N.V.,
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`a corporation;
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`and
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`UTAH ACQUISITION SUB INC.,
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`a corporation.
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`________________________________________________)
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`COMPLAINT
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`Pursuant to the Clayton Act and the Federal Trade Commission Act (“FTC Act”), and its
`authority thereunder, the Federal Trade Commission (“Commission”), having reason to believe
`that Respondent Pfizer Inc. proposes to combine certain of its assets and liabilities, including
`Respondent Upjohn Inc. and Respondent Utah Acquisition Sub Inc., with Respondent Mylan
`N.V. to form Respondent Viatris Inc., all Respondents being corporations subject to the
`jurisdiction of the Commission, in violation of Section 5 of the FTC Act, as amended, 15 U.S.C.
`§ 45, and that such combination, if consummated, would violate Section 7 of the Clayton Act, as
`amended, 15 U.S.C. § 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. § 45, and it
`appearing to the Commission that a proceeding in respect thereof would be in the public interest,
`hereby issues its Complaint, stating its charges as follows:
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`1
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`1.
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`7.
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`I. RESPONDENTS
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`Respondent Pfizer Inc. is a corporation organized, existing, and doing business under and
`by virtue of the laws of the State of Delaware with its executive offices and principal
`place of business located at 235 East 42nd Street, New York, New York 10017.
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`Respondent Upjohn Inc. is a corporation organized, existing, and doing business under
`and by virtue of the laws of the State of Delaware with its executive offices and principal
`place of business located at 235 East 42nd Street, New York, New York 10017. Upjohn
`houses Pfizer’s authorized generic distributor, Greenstone LLC. After the proposed
`transaction, Upjohn Inc. is to be renamed Viatris Inc.
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`Respondent Viatris Inc. is or will be a successor corporation of Upjohn Inc. Viatris is or
`will be a corporation organized, existing, and doing business under and by virtue of the
`laws of the State of Delaware with its executive offices and principal place of business
`located at 1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317.
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`Respondent Mylan N.V. is a public limited liability company organized, existing, and
`doing business under and by virtue of the laws of the Kingdom of the Netherlands with its
`executive offices and principal place of business located at Building 4, Trident Place,
`Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, England. Mylan N.V. includes
`Mylan I B.V. and Mylan II B.V (collectively, “Respondent Mylan”). Mylan N.V.’s
`United States address for service of process is Mylan Inc., 1000 Mylan Boulevard,
`Canonsburg, Pennsylvania 15317.
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`Respondent Utah Acquisition Sub Inc. is a corporation organized, existing, and doing
`business under and by virtue of the laws of the State of Delaware with its executive
`offices and principal place of business located at 235 East 42nd Street, New York, New
`York 10017.
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`Each Respondent is, and at all times relevant herein has been or will be, engaged in
`commerce, as “commerce” is defined in Section 1 of the Clayton Act as amended, 15
`U.S.C. § 12, and engages in business that is in or affects commerce, as “commerce” is
`defined in Section 4 of the FTC Act, as amended, 15 U.S.C. § 44.
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`II. THE PROPOSED COMBINATION
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`Pursuant to a Separation and Distribution Agreement by and between Pfizer Inc. and
`Upjohn Inc., dated July 29, 2019, and the Business Combination Agreement by and
`among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V.,
`and Mylan II B.V., dated July 29, 2019 (collectively, the “Agreements”), Respondent
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`Pfizer will combine certain of its assets and liabilities with Respondent Mylan to form
`Respondent Viatris (the “Combination”). Respondent Pfizer will receive $12 billion in
`cash from Viatris as partial consideration in connection with the Combination, and
`Respondent Pfizer’s shareholders will gain an interest in Respondent Viatris. The
`Combination is subject to Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18.
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`III. THE RELEVANT MARKETS
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`The relevant lines of commerce in which to analyze the effects of the Combination are the
`development, license, manufacture, marketing, distribution, and sale of the following
`generic pharmaceutical products:
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`a. Amlodipine besylate/atorvastatin calcium tablets;
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`b. Eplerenone tablets;
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`c. Gatifloxacin ophthalmic solution;
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`d. Levothyroxine sodium tablets;
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`e. Medroxyprogesterone acetate injectable solution;
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`f. Phenytoin chewable tablets;
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`g. Prazosin hydrochloride capsules;
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`h. Spironolactone hydrochlorothiazide tablets;
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`i. Sucralfate tablets; and
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`j. Varenicline tartrate tablets.
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`The United States is the relevant geographic area in which to assess the competitive
`effects of the Combination in the relevant lines of commerce.
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`IV. THE STRUCTURE OF THE MARKETS
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`Amlodipine besylate/atorvastatin calcium tablets combine a calcium channel blocker to
`treat hypertension with a lipid-lowering agent to treat high cholesterol. Only four
`companies sell generic amlodipine besylate/atorvastatin calcium tablets: Greenstone,
`Mylan, Dr. Reddy’s Laboratories Ltd., and Apotex Inc. The Combination will reduce the
`number of current suppliers from four to three. In all eleven strengths of amlodipine
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`11.
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`besylate/atorvastatin calcium tablets, Greenstone and Mylan account for greater than 30
`percent of the market combined.
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`Eplerenone is a diuretic that is prescribed as an adjunctive therapy when treating
`hypertension or congestive heart failure after a heart attack. Significant sellers of
`eplerenone include Greenstone, Mylan, Breckenridge Pharmaceutical, Inc., and Accord
`Healthcare Inc. In both the 25mg and 50mg strengths, the Combination would reduce
`the number of significant suppliers and result in the combined entity accounting for
`approximately 50 percent of eplerenone tablets sold.
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`Gatifloxacin ophthalmic solution is an eye drop that treats bacterial conjunctivitis caused
`by susceptible strains of certain bacteria. The market for gatifloxacin has faced historical
`supply disruptions. Five companies supply this product today: Greenstone, Mylan,
`Sandoz International GmbH, Akorn, Inc., and Lupin Ltd. Together, Greenstone and
`Mylan account for more than 60 percent of gatifloxacin sales.
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`Levothyroxine sodium tablets are offered in a host of strengths and are prescribed to treat
`hypothyroidism or as an adjunct therapy for patients undergoing treatment for thyroid
`cancer. Suppliers for levothyroxine sodium tablets vary by strength. Should Upjohn or
`Greenstone launch an authorized generic of Pfizer’s levothyroxine sodium branded
`product (Levoxyl®), the Combination would likely allow the combined entity to reduce
`the number of independent suppliers of some strengths of generic levothyroxine sodium
`tablets from three to two.
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`14. Medroxyprogesterone acetate is an injectable solution used to treat certain types of
`dysfunctional uterine bleeding. Injectable products, such as medroxyprogesterone
`acetate, often experience shortages and supply disruptions. Greenstone, Mylan,
`Amphastar Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., and Sun
`Pharmaceutical Industries Ltd. currently supply medroxyprogesterone acetate.
`Combined, Greenstone and Mylan account for more than 50 percent of the market.
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`Phenytoin chewable tablets are an anti-epileptic drug that slows down impulses in the
`brain that cause seizures. Only three suppliers provide phenytoin chewable tablets today:
` Greenstone, Mylan, and Taro Pharmaceutical Industries Ltd. The Combination would
`reduce the number of available suppliers and result in Greenstone and Mylan accounting
`for more than 40 percent of phenytoin chewable tablets sold.
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`Prazosin hydrochloride (HCl) capsules are an alpha-adrenergic blocker that treats
`hypertension by relaxing the veins and arteries so that blood can more easily pass. The
`market for prazosin HCl capsules is supplied by four companies: Greenstone, Mylan,
`Teva, and Novitium Pharma LLC. Across the three strengths of prazosin HCl available
`today, the Combination would reduce the number of available suppliers and result in the
`combined entity accounting for approximately half of prazosin HCl capsules sold.
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`17.
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`Spironolactone hydrochlorothiazide (HCTZ) tablets are a diuretic used to treat
`hypertension. Only three suppliers provide spironolactone HCTZ tablets: Greenstone,
`Mylan, and Sun. The Combination would reduce the number of suppliers from three to
`two and result in Greenstone and Mylan accounting for more than 30 percent of the
`market.
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`Sucralfate tablets are used to treat and prevent ulcers in the small intestines. Prior to the
`proposed Combination, only three companies sold sucralfate tablets historically:
`Greenstone, Mylan, and Teva. While Mylan has stopped selling sucralfate recently, the
`proposed Combination likely alters Mylan’s incentives to relaunch sucralfate tablets and
`would reduce the number of firms capable of selling sucralfate tablets from three to two.
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`Varenicline tartrate tablets are a smoking cessation aid offered under Pfizer’s brand
`Chantix®. Currently, only branded Chantix® is available in the market. Mylan is one
`of a limited number of companies likely to share the Hatch-Waxman 180-day exclusivity
`period when the generic market forms. Should Upjohn or Greenstone launch an
`authorized generic of Pfizer’s Chantix®, the Combination would likely allow the
`combined entity to reduce the small number of independent suppliers that would have
`sold generic varenicline tartrate tablets during the Hatch-Waxman exclusivity period
`absent the Combination.
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`V. ENTRY CONDITIONS
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`Entry into the relevant markets described in Paragraphs 10-19 would not be timely, likely,
`or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive
`effects of the Combination. De novo entry would not take place in a timely manner
`because the combination of drug development times and FDA approval requirements
`would be lengthy. In addition, no other entry is likely to occur such that it would be
`timely and sufficient to deter or counteract the competitive harm likely to result from the
`Combination.
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`VI. EFFECTS OF THE COMBINATION
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`The effects of the Combination, if consummated, may be to substantially lessen
`competition in violation of Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and
`Section 5 of the FTC Act, as amended, 15 U.S.C. § 45, in the following ways, among
`others:
`a.
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`by eliminating actual, direct, and substantial competition between Upjohn and
`Greenstone and Mylan and reducing the number of independent significant
`competitors in the markets for: (1) generic amlodipine besylate/atorvastatin
`calcium tablets; (2) generic eplerenone tablets; (3) generic gatifloxacin ophthalmic
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`solution; (4) generic medroxyprogesterone acetate injectable solution; (5) generic
`phenytoin chewable tablets; (6) generic prazosin HCl capsules; and (7) generic
`spironolactone HCTZ tablets, thereby increasing the likelihood that: (a) Viatris
`would be able to unilaterally exercise market power in these markets; (b) the
`remaining competitors would engage in coordinated interaction between or among
`each other; and (c) customers would be forced to pay higher prices; and
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`b.
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`by eliminating future competition between (1) Upjohn and Greenstone and (2)
`Mylan in the market for generic levothyroxine sodium tablets, generic sucralfate
`tablets, and generic varenicline tartrate tablets, thereby (a) increasing the
`likelihood that the combined entity would forego or delay relaunching this
`product, and (b) increasing the likelihood that the combined entity would delay,
`eliminate, or otherwise reduce the substantial additional price competition that
`would have resulted from an additional supplier of this product.
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`VII. VIOLATIONS CHARGED
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`The Combination described in Paragraph 7 constitutes a violation of Section 5 of the FTC
`Act, as amended, 15 U.S.C. § 45.
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`The Combination described in Paragraph 7, if consummated, would constitute a violation
`of Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the FTC
`Act, as amended, 15 U.S.C. § 45.
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`22.
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`23.
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`WHEREFORE, THE PREMISES CONSIDERED, the Federal Trade
`Commission on this thirtieth day of October, 2020 issues its Complaint against said Respondents.
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`By the Commission, Commissioners Chopra and Slaughter dissenting.
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`SEAL:
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`April J. Tabor
`Acting Secretary
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