Supernus Announces Orphan Drug Exclusivity for ONAPGO™ (apomorphine HCl)

A second ONAPGO supplier is under FDA review, with potential approval expected by mid-year 2027.

Rhea-AI Summary

Supernus (SUPN) announced FDA recognition of seven years of orphan-drug exclusivity for ONAPGO to treat motor fluctuations in advanced Parkinson’s disease.

The exclusivity began on February 3, 2025, when the FDA approved ONAPGO (apomorphine HCl), and covers treatment in adults. The FDA’s orphan-drug designation program supports development of drugs for conditions affecting 200,000 or fewer U.S. patients annually.

Supernus also submitted a supplemental New Drug Application, an application to change an existing approval, for a second ONAPGO supplier. The company continues to expect potential FDA approval of that supplier by mid-year 2027. Supernus also said it has resolved the supply issue experienced earlier this year; approval of the second supplier remains pending.

3 points · 0 major

PositiveiHow this balance works

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointSeven years of ONAPGO orphan-drug exclusivity began February 3, 2025, the FDA approval date.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Second-supplier application submitted; Supernus continues to expect potential FDA approval by mid-year 2027.
• Moderate pointEarlier ONAPGO supply issue resolved, Supernus said.

Negative

• Minor pointSecond ONAPGO supplier still requires FDA approval.

Key Figures

Orphan-drug market exclusivity: 7 years Potential second-supplier approval: Mid-year 2027

Orphan-drug market exclusivity

7 years

For ONAPGO; began February 3, 2025

Potential second-supplier approval

Mid-year 2027

Company's stated expectation following sNDA submission

Key Terms

orphan-drug exclusivity, snda, subcutaneous

3 terms

orphan-drug exclusivity regulatory

"recognized seven years of orphan-drug exclusive approval for ONAPGO"

A regulatory period of market exclusivity granted to a drug that has been designated and approved as an orphan treatment for a rare disease. During this exclusivity window the drug regulatory authority will not approve the same drug for the same indication from a different sponsor, but the exclusivity does not bar approval of different drugs for the same disease, nor does it prevent physicians from prescribing approved drugs off‑label for other uses; the length and specific rules depend on the jurisdiction (for example, seven years in the U.S. and ten years in the EU).

snda regulatory

"submitted a supplemental New Drug Application (sNDA) to the FDA"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

subcutaneous medical

"the first and only subcutaneous apomorphine infusion device"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

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Orphan-drug exclusivity provides seven years of market exclusivity for ONAPGO

Additionally, the Company submitted an sNDA to the FDA for a second supplier for ONAPGO, with potential approval by mid-year 2027

ROCKVILLE, Md., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Supernus, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.

The seven-year market exclusivity for ONAPGO began on February 3, 2025, the date of FDA approval. The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.

In addition, the Company submitted a supplemental New Drug Application (sNDA) to the FDA for a second supplier for ONAPGO and continues to expect potential FDA approval of the second supplier by mid-year 2027.

"Securing orphan-drug exclusivity marks an important milestone for individuals and families navigating Parkinson's disease. This designation validates the urgent need for targeted therapies and helps safeguard continued innovation in a long-underserved community," said Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "In addition to resolving the supply issue from earlier this year, submitting our sNDA further reinforces our ongoing commitment to providing novel treatments for patients with Parkinson's disease, backed by our unwavering focus on ensuring an uninterrupted drug supply for every patient in need."

More information about ONAPGO, including Full Prescribing Information and Medication Guide, is available here: www.onapgo.com.

About Supernus, Inc.

Supernus, Inc. is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company's ability to increase its net revenue from its products and the products of its subsidiaries; the Company's ability to commercialize its products and the products of its subsidiaries; the Company's ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates or manufacture ONAPGO at the second supplier; the Company's ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company's ability to increase its manufacturing capabilities for its products, including ONAPGO, and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs and potential funding sources; the Company's staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

Supernus, Inc. Contacts

Jack A. Khattar, President and CEO
Tim Dec, Senior Vice President and CFO
Supernus, Inc.
(301) 838-2591

Investors

Peter Vozzo
ICR Healthcare
(443) 213-0505
Email: peter.vozzo@icrhealthcare.com

Media
Diana Torres-Bixby
Burson Global
+1 917 686 0517
Email: Diana.torres-bixby@bursonglobal.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How long does Supernus’s ONAPGO orphan-drug exclusivity last, and when did it begin?

ONAPGO received seven years of orphan-drug exclusivity beginning February 3, 2025, its FDA approval date. The exclusive approval covers treatment of motor fluctuations in adults with advanced Parkinson’s disease.

When could Supernus receive FDA approval for a second ONAPGO supplier?

Supernus continues to expect potential FDA approval of a second ONAPGO supplier by mid-year 2027. The company has submitted a supplemental New Drug Application for that supplier; approval remains pending.