UNITED STATES OF AMERICA (2025)

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

WASHINGTON, D.C. 20580

Bureau of Competition

May 21, 2025

General Counsel

Amphastar Pharmaceuticals Inc.

11570 6th Street

Rancho Cucamonga, CA 91730

brianm@amphastar.com

Re:

Improper Orange Book Patent Listing for Baqsimi

Dear Counsel,

I write regarding Amphastar Pharmaceuticals Inc.’s (“Amphastar”) ongoing obligation to

ensure the propriety of its patent listings in the FDA’s Approved Drug Products with Therapeutic

Equivalence Evaluations (the “Orange Book”), particularly in light of the U.S. Court of Appeals

for the Federal Circuit’s decision in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms.

of N.Y., LLC, 124 F.4th 898 (Fed. Cir. 2024) (hereinafter “Teva v. Amneal”).

The FTC has previously explained that patents improperly listed in the Orange Book may

harm competition and delay generic drug entry, as courts have recognized.1 On April 30, 2024,

the FTC’s Bureau of Competition (the “Bureau) sent a letter identifying a non-exhaustive list of

patents that Amphastar had improperly submitted for listing in the Orange Book and explained

how improper Orange Book listings may harm competition.2 Since that letter was sent, the

1

Fed. Trade Comm’n, Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the

Orange Book (Sept. 14, 2023), https://www.ftc.gov/system/files/ftc_gov/pdf/

p239900orangebookpolicystatement092023.pdf; Brief for Fed. Trade Comm’n as Amicus Curiae, SmithKline

Beecham Corp. v. Apotex Corp., No. 99-CV-4304 (E.D. Pa. Jan. 28, 2003), https://www.ftc.gov/sites/default/files/

documents/amicus_briefs/smithkline-beecham-corp.v.apotex-corp./smithklineamicus.pdf; Caraco Pharm. Labs.,

Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 408 (2012); see also Massachusetts Laborer’s Health & Welfare Fund v.

Boehringer Ingelheim Pharms., Inc., No. 24-CV-10565-DJC, 2025 WL 928747, at *20 (D. Mass. Mar. 27, 2025)

(“[Plaintiff’s] alleged injury, having to pay higher prices for drugs it otherwise would not need to but for

[Defendants’] allegedly wrongful listing, is the precisely the kind of ‘[t]hreaten[ed] economic harm to consumers

[that] is plainly sufficient to authorize injunctive relief.’” (quoting New York ex rel. Schneiderman v. Actavis PLC,

787 F.3d 638, 661 (2d Cir. 2015) (cleaned up)).

2

Apr. 30, 2024 Letter from R. Rao, Deputy Director, Bureau of Competition, to Amphastar Pharmaceuticals

Inc., https://www.ftc.gov/system/files/ftc_gov/pdf/amphastar-baqsimi-4302024.pdf.

Federal Circuit’s ruling in the Teva v. Amneal case has confirmed that the identified patent does

not meet applicable Orange Book listing criteria.3

The following patent included in the Bureau’s prior delisting letter remains in the Orange

Book as of the date of this letter:

NDA

Product(s)

Proprietary

Name

Patent Number

Listing Type

210134

1

Baqsimi

10894133

DP

With the above patent still in the Orange Book, we are, contemporaneously with this

letter, submitting patent listing dispute communications to the FDA regarding this patent.

Although we have not, at this time, disputed the listing of any other Amphastar patents, it is

Amphastar’s responsibility to ensure that all of its patent listings comply with the statutory

listing requirements, as clarified by Teva v. Amneal.

Combatting improper Orange Book patent listings has been a part of the FTC’s longstanding enforcement and advocacy work to challenge anticompetitive conduct that stymies

generic drug entry and the resulting substantial cost savings.4 The FTC will remain vigilant to

promote competition and protect the American public from the harms that flow from

anticompetitive practices in the pharmaceutical industry.

Sincerely,

/s/ Kelse Moen

Kelse Moen

Deputy Director

Bureau of Competition

3

Teva v. Amneal, 124 F.4th at 911 (explaining that a patent claims the drug as required for listing in the Orange

Book “when it particularly points out and distinctly claims the drug as the invention.”).

4

See, e.g., Biovail Corp., 134 F.T.C. 407 (2002), https://www.ftc.gov/sites/default/files/documents/cases/

2002/10/biovaildo.pdf; Brief for Fed. Trade Comm’n as Amicus Curiae, Jazz Pharms., Inc. v. Avadel CNS Pharms.

No. 1:21-cv-00691 (D. Del. Nov. 10, 2022), ECF No. 222-3; Brief for Fed. Trade Comm’n as Amicus Curiae, Teva

Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936 (Fed. Cir. Sept. 6, 2024), ECF No.

62; see also Mem. of Law of Amicus Curiae the Federal Trade Commission in Opp’n to Defs.’ Mot. to Dismiss, In

re: Buspirone Patent Litig., MDL Docket No. 1410 (S.D.N.Y. Jan. 8, 2002),

https://www.ftc.gov/sites/default/files/documents/amicus_briefs/re-buspirone-antitrust-litigation/buspirone.pdf; see

also Fed. Trade Comm’n, Overview of FTC Actions in Pharmaceutical Products and Distribution (Sept. 2021),

https://www.ftc.gov/system/files/attachments/competition-policyguidance/overview_of_ftc_actions_in_pharmaceutical_products_and_distribution.pdf.