Litigation	12 Months Ended
Dec. 31, 2021
Litigation
Litigation	Note 20. Litigation Momenta/Sandoz Enoxaparin Patent and Antitrust Litigation In September 2011, Momenta Pharmaceuticals, Inc., or Momenta, a Boston based pharmaceutical company, and Sandoz Inc., or Sandoz, the generic division of Novartis, initiated litigation against the Company for alleged patent infringement of two patents related to testing methods for batch release of enoxaparin, which the Company refers to as the “’886 patent” and the “’466 patent.” On September 17, 2015, the Company initiated an antitrust lawsuit by filing a complaint in the California District Court against Momenta and Sandoz. This lawsuit was subsequently transferred to the Massachusetts District Court. On May 20, 2019, the Company and Momenta and Sandoz entered into a Settlement Agreement to settle the patent litigation and antitrust litigation. On June 27, 2019, Momenta and Sandoz paid the Company $59.9 million. The Company recorded the settlement amount as other income (expenses), in its consolidated statements of operations. Amphastar Pharmaceuticals, Inc. v Aventis Pharma, SA In January 2009, the Company filed a qui tam complaint in the U.S. District Court for the Central District of California, alleging that Aventis Pharma S.A., or Aventis, through its acquisition of a patent through false and misleading statements to the U.S. Patent and Trademark Office, as well as through false and misleading statements to the FDA, overcharged the federal and state governments for its Lovenox^® product (the “Aventis FCA Action”). On May 11, 2017, the Company’s lawsuit against Aventis was dismissed for lack of jurisdiction. On July 14, 2017, Aventis filed an application with the District Court for entitlement to attorneys’ fees and expenses. On November 20, 2017, the District Court issued its order granting Aventis’ application for fees, and on November 13, 2020, the Court issued an Order (“November Order”) awarding Aventis $12.1 million in attorneys’ fees and $0.7 million in costs and expenses. The Company recorded $12.8 million in other income (expenses) in the consolidated statement of operations for the year ended December 31, 2020. On May 3, 2021, the Court issued a further Order based upon supplemental application to the Court seeking fees, expenses, and interest for the period after, and not covered by, the November Order. The Court awarded Aventis an additional $4.4 million bringing the total amount awarded to Aventis to $17.2 million. On June 30, 2021, the Company and Aventis entered into a settlement agreement to settle the attorney fees’ and expenses claim for $14.5 million. The additional $1.7 million was recorded in other income (expenses), in the consolidated statement of operations. The settlement was paid in full in the third quarter of 2021. Hatch-Waxman Litigations Regadenoson (0.4 mg/5 mL, 0.08 mg/mL) Patent Litigation On February 25, 2020, Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc. (collectively, “Astellas-Gilead”) filed a Complaint in the United States District Court for the District of Delaware against IMS for infringement of U.S. Patent Nos. 8,106,183 (the “‘183 patent”), RE47,301 (the “‘301 patent”), and 8,524,883 (the “‘883 patent”) (collectively, “Astellas-Gilead Patents”) with regard to IMS’s ANDA No. 214,252 for approval to manufacture and sell 0.4 mg/5 mL (0.08 mg/mL) intravenous solution of Regadenoson. On March 4, 2020, IMS filed its Answer and Counterclaims. On March 30, 2020, the Court issued an Order allowing the Company to join pending consolidated litigation with five other generic Regadenoson ANDA filers involving similar claims. The Company’s 30-month FDA stay expires August 10, 2022. On January 26, 2022, the Company and Astellas-Gilead reached an agreement to resolve the lawsuit. The parties submitted, and the Court granted, a motion to dismiss without prejudice Astellas-Gilead’s complaint of infringement against IMS on January 27, 2022. Teriparatide (0.25 mg/mL) Patent Litigation On June 29, 2021, the Company filed a Complaint in the United States District Court for the Southern District of Indiana against Eli Lilly and Company (“Lilly”) seeking a declaratory judgment of non-infringement of U.S. Patent No. 7,517,334 with regard to Amphastar’s ANDA No. 213,641 for approval to manufacture and sell 0.25 mg/mL prefilled pens. On September 30, 2021, the Company and Lilly submitted a motion for entry of a consent judgment of non-infringement of Amphastar’s ANDA No. 213,641 in favor of Amphastar and against Lilly. The Court endorsed the consent judgment and issued a final determination in favor of Amphastar and against Lilly on October 1, 2021. Employee Litigations Brenes v. International Medication Systems, Limited On September 11, 2019, a former employee, Raquel Brenes, (“Brenes”), initiated an employment litigation against IMS et al. by filing a Complaint in the Superior Court of California, Los Angeles County alleging individual and class action claims for alleged violations of various California labor laws pertaining to wage and hour, and other state laws. On September 18, 2019, Brenes filed a First Amended Complaint maintaining the individual and class action claims. On January 21, 2020, Brenes filed a Second Amended Complaint that alleges only Private Attorney General Act, or PAGA, claims and omitted the individual and class action claims. On February 9, 2021, the Company was able to successfully resolve these claims, as well as Brenes’ personal employment claims at mediation for $1.0 million. The settlement was approved by the Court on April 7, 2021. The Company accrued the amount of $1.0 million as of December 31, 2020. Ramirez v. Amphastar Pharmaceuticals, Inc. On May 29, 2020, Priscilla Ramirez, (“Ramirez”), a former employee filed a PAGA lawsuit for alleged violations of various California labor laws pertaining to wage and hour against the Company. The Company accrued the amount of $1.0 million for this litigation as of March 31, 2021. On April 5, 2021, the parties reached a settlement for $1.0 million. On June 9, 2021, Ramirez submitted a motion to the Court seeking approval of the settlement. On August 16, 2021, the Court approved the settlement. On September 13, 2021, consistent with the terms of the settlement agreement, the Company remitted payment for this case, thus resolving the matter. Navarrette v. International Medication Systems, Limited On January 30, 2020, a former employee, Robert Navarrette, (“Navarrette”), provided written notice, through his counsel to IMS that he intends to file a PAGA lawsuit for alleged violations of various California labor laws pertaining to wage and hour. On April 7, 2020, Navarrete filed his PAGA lawsuit against IMS and Amphastar Pharmaceuticals, Inc. in the Superior Court of California, Los Angeles County, Central District. As to IMS, the Brenes settlement subsumes the claims of Navarrette. As to the Company, the Ramirez settlement subsumes the claims of Navarette covering overlapping periods. Other Litigation The Company is also subject to various other claims, arbitrations, and lawsuits from time to time arising in the ordinary course of business. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.

Litigation

12 Months Ended

Dec. 31, 2021

Note 20. Litigation

Momenta/Sandoz Enoxaparin Patent and Antitrust Litigation

In September 2011, Momenta Pharmaceuticals, Inc., or Momenta, a Boston based pharmaceutical company, and Sandoz Inc., or Sandoz, the generic division of Novartis, initiated litigation against the Company for alleged patent infringement of two patents related to testing methods for batch release of enoxaparin, which the Company refers to as the “’886 patent” and the “’466 patent.”

On September 17, 2015, the Company initiated an antitrust lawsuit by filing a complaint in the California District Court against Momenta and Sandoz. This lawsuit was subsequently transferred to the Massachusetts District Court.

On May 20, 2019, the Company and Momenta and Sandoz entered into a Settlement Agreement to settle the patent litigation and antitrust litigation. On June 27, 2019, Momenta and Sandoz paid the Company $59.9 million. The Company recorded the settlement amount as other income (expenses), in its consolidated statements of operations.

Amphastar Pharmaceuticals, Inc. v Aventis Pharma, SA

In January 2009, the Company filed a qui tam complaint in the U.S. District Court for the Central District of California, alleging that Aventis Pharma S.A., or Aventis, through its acquisition of a patent through false and misleading statements to the U.S. Patent and Trademark Office, as well as through false and misleading statements to the FDA, overcharged the federal and state governments for its Lovenox^® product (the “Aventis FCA Action”).

On May 11, 2017, the Company’s lawsuit against Aventis was dismissed for lack of jurisdiction. On July 14, 2017, Aventis filed an application with the District Court for entitlement to attorneys’ fees and expenses. On November 20, 2017, the District Court issued its order granting Aventis’ application for fees, and on November 13, 2020, the Court issued an Order (“November Order”) awarding Aventis $12.1 million in attorneys’ fees and $0.7 million in costs and

expenses. The Company recorded $12.8 million in other income (expenses) in the consolidated statement of operations for the year ended December 31, 2020.

On May 3, 2021, the Court issued a further Order based upon supplemental application to the Court seeking fees, expenses, and interest for the period after, and not covered by, the November Order. The Court awarded Aventis an additional $4.4 million bringing the total amount awarded to Aventis to $17.2 million.

On June 30, 2021, the Company and Aventis entered into a settlement agreement to settle the attorney fees’ and expenses claim for $14.5 million. The additional $1.7 million was recorded in other income (expenses), in the consolidated statement of operations. The settlement was paid in full in the third quarter of 2021.

Hatch-Waxman Litigations

Regadenoson (0.4 mg/5 mL, 0.08 mg/mL) Patent Litigation

On February 25, 2020, Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc. (collectively, “Astellas-Gilead”) filed a Complaint in the United States District Court for the District of Delaware against IMS for infringement of U.S. Patent Nos. 8,106,183 (the “‘183 patent”), RE47,301 (the “‘301 patent”), and 8,524,883 (the “‘883 patent”) (collectively, “Astellas-Gilead Patents”) with regard to IMS’s ANDA No. 214,252 for approval to manufacture and sell 0.4 mg/5 mL (0.08 mg/mL) intravenous solution of Regadenoson. On March 4, 2020, IMS filed its Answer and Counterclaims. On March 30, 2020, the Court issued an Order allowing the Company to join pending consolidated litigation with five other generic Regadenoson ANDA filers involving similar claims. The Company’s 30-month FDA stay expires August 10, 2022. On January 26, 2022, the Company and Astellas-Gilead reached an agreement to resolve the lawsuit. The parties submitted, and the Court granted, a motion to dismiss without prejudice Astellas-Gilead’s complaint of infringement against IMS on January 27, 2022.

Teriparatide (0.25 mg/mL) Patent Litigation

On June 29, 2021, the Company filed a Complaint in the United States District Court for the Southern District of Indiana against Eli Lilly and Company (“Lilly”) seeking a declaratory judgment of non-infringement of U.S. Patent No. 7,517,334 with regard to Amphastar’s ANDA No. 213,641 for approval to manufacture and sell 0.25 mg/mL prefilled pens. On September 30, 2021, the Company and Lilly submitted a motion for entry of a consent judgment of non-infringement of Amphastar’s ANDA No. 213,641 in favor of Amphastar and against Lilly. The Court endorsed the consent judgment and issued a final determination in favor of Amphastar and against Lilly on October 1, 2021.

Employee Litigations

Brenes v. International Medication Systems, Limited

On September 11, 2019, a former employee, Raquel Brenes, (“Brenes”), initiated an employment litigation against IMS et al. by filing a Complaint in the Superior Court of California, Los Angeles County alleging individual and class action claims for alleged violations of various California labor laws pertaining to wage and hour, and other state laws. On September 18, 2019, Brenes filed a First Amended Complaint maintaining the individual and class action claims. On January 21, 2020, Brenes filed a Second Amended Complaint that alleges only Private Attorney General Act, or PAGA, claims and omitted the individual and class action claims. On February 9, 2021, the Company was able to successfully resolve these claims, as well as Brenes’ personal employment claims at mediation for $1.0 million. The settlement was approved by the Court on April 7, 2021. The Company accrued the amount of $1.0 million as of December 31, 2020.

Ramirez v. Amphastar Pharmaceuticals, Inc.

On May 29, 2020, Priscilla Ramirez, (“Ramirez”), a former employee filed a PAGA lawsuit for alleged violations of various California labor laws pertaining to wage and hour against the Company. The Company accrued the amount of

$1.0 million for this litigation as of March 31, 2021. On April 5, 2021, the parties reached a settlement for $1.0 million. On June 9, 2021, Ramirez submitted a motion to the Court seeking approval of the settlement. On August 16, 2021, the Court approved the settlement. On September 13, 2021, consistent with the terms of the settlement agreement, the Company remitted payment for this case, thus resolving the matter.

Navarrette v. International Medication Systems, Limited

On January 30, 2020, a former employee, Robert Navarrette, (“Navarrette”), provided written notice, through his counsel to IMS that he intends to file a PAGA lawsuit for alleged violations of various California labor laws pertaining to wage and hour. On April 7, 2020, Navarrete filed his PAGA lawsuit against IMS and Amphastar Pharmaceuticals, Inc. in the Superior Court of California, Los Angeles County, Central District. As to IMS, the Brenes settlement subsumes the claims of Navarrette. As to the Company, the Ramirez settlement subsumes the claims of Navarette covering overlapping periods.

Other Litigation

The Company is also subject to various other claims, arbitrations, and lawsuits from time to time arising in the ordinary course of business.

The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.