UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

June 29, 2017

VIVUS, INC.

(Exact name of registrant as specified in its charter)

900 E. HAMILTON AVENUE, SUITE 550

CAMPBELL, CA 95008

(Address of principal executive offices, including zip code)

(650) 934-5200

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company   o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   o

Item 1.01.  Entry into a Material Definitive Agreement

On June 29, 2017, VIVUS, Inc., or the Company, entered into a Settlement Agreement and a License Agreement with Actavis Laboratoris FL, Inc., or Actavis.  The Settlement Agreement resolves the action for patent infringement brought by the Company in the U.S. District Court for the District of New Jersey (Civil Action No. 14-3786 (SRC)(CLW)(consolidated)) in response to Actavis’ filing of an Abbreivated New Drug Application, or ANDA, seeking to market and sell generic versions of Qsymia® (phentermine and topiramate extended-release) capsules CIV prior to the expiration of U.S. Patents 7,056,890; 7,553,818; 7,659,256; 7,674,776; 8,580,298; 8,580,299; 8,895,057; 8,895,058; 9,011,905; and 9,011,906, collectively referred to as the Asserted Patents.  Under the License Agreement, Actavis was granted a non-exclusive license to manufacture and sell generic versions of Qsymia described in its ANDA filing in the United States as of the date that is the earlier of December 1, 2024 or the date determined by certain triggering events.  Additionally, VIVUS will receive royalty payments on the sale of the generic versions of Qsymia should Actavis be entitled to sell them prior to December 1, 2024. The Settlement Agreement provides for a full settlement of all claims that were asserted in the suit, subject to the Court’s acceptance of the stipulation of dismissal.  As required by law, the Settlement Agreement (including the License Agreement) will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.

Item 9.01. Financial Statements and Exhibits

(d)           Exhibits.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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EXHIBIT INDEX

4

Exhibit 99.1

VIVUS Announces Settlement with Actavis on Qsymia® Patent Litigation

CAMPBELL, CA — July 5, 2017 — VIVUS, Inc. (NASDAQ: VVUS) announced today that it has entered into a settlement agreement with Actavis Laboratories FL (Actavis) resolving patent litigation related to Qsymia® (phentermine and topiramate extended-release) capsules CIV.  The litigation, which has been pending in the U.S. District Court for the District of New Jersey since 2014, resulted from the submission by Actavis of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market generic versions of Qsymia.  The settlement agreement permits Actavis to begin selling a generic version of Qsymia on December 1, 2024, or earlier under certain circumstances.  In the event of a launch earlier than December 1, 2024, VIVUS will receive a royalty on sales of the generic version of Qsymia.

“We are pleased to have this litigation resolved and remain confident in the strength of our intellectual property for Qsymia and our other products and technologies,” said Seth H. Z. Fischer, VIVUS’ Chief Executive Officer. “We will continue to defend our existing patents, and intend to further expand our portfolio of intellectual property as we innovate therapies that advance treatment for patients with serious unmet medical needs.”

As required by law, VIVUS and Actavis will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by VIVUS against Dr. Reddy’s Laboratories, S.A. and Dr. Reddy’s Laboratories, Inc. remains pending in the U.S. District Court for the District of New Jersey.

About Qsymia

Qsymia is approved in the United States and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.

Important Safety Information

Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

About VIVUS

VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to protect our intellectual property and litigation in which we are involved or may become involved; and risks and uncertainties related to our ability to continue to identify, acquire and develop innovative investigational drug candidates and drugs. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2016 as filed on March 8, 2017 and as amended by the Form 10-K/A filed on April 26, 2017, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.