OSMOLEX ER Drug Patent Profile

When do Osmolex Er patents expire, and what generic alternatives are available?

Osmolex Er is a drug marketed by Supernus Pharms and is included in one NDA. There are nine patents protecting this drug.

This drug has fifteen patent family members in nine countries.

The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Osmolex Er

A generic version of OSMOLEX ER was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5^th, 1986.

Summary for OSMOLEX ER

International Patents:	15
US Patents:	9
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for OSMOLEX ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSMOLEX ER
What excipients (inactive ingredients) are in OSMOLEX ER?	OSMOLEX ER excipients list
DailyMed Link:	OSMOLEX ER at DailyMed

See drug prices for OSMOLEX ER

US Patents and Regulatory Information for OSMOLEX ER

OSMOLEX ER is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	10,500,170
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	10,500,172
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	8,252,331		Y

Expired US Patents for OSMOLEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	8,895,614
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	8,895,614
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	8,889,740

International Patents for OSMOLEX ER

See the table below for patents covering OSMOLEX ER around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	053986	DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA
Australia	2005328058	Osmotic device containing amantadine and an osmotic salt
Brazil	PI0515761	dispositivo osmótico contendo amantadina e um sal osmótico

Last updated: July 2, 2026

OSMOLEX ER market dynamics and financial trajectory (bexarotene)

Executive summary: OSMOLEX ER (bexarotene extended-release) has a small, specialty footprint tied to its single labeled indication in cutaneous T-cell lymphoma (CTCL). Demand is constrained by age, imaging and skin disease management practices, and payer scrutiny typical for Targretin-class retinoids. Financial trajectory tracks with prescription counts and payer access rather than broad formulary expansion, with additional downside from generic/therapeutic substitution risk in retinoid-derivative space and persistent high price-per-month exposure.

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What is OSMOLEX ER and how does it generate revenue?

Answer: OSMOLEX ER is an extended-release oral formulation of bexarotene, positioned for CTCL. Revenue is driven by prescription volume, persistence, and net price after rebates/discounts, not by route-of-administration conversion or broad line-of-therapy uptake.

Drug profile

• Active ingredient: bexarotene
• Formulation: extended-release (ER) capsule
• Therapeutic area: hematology-oncology (CTCL)
• Commercial model: specialty channel, typically with high rebate and prior authorization in many plans due to cost and limited patient pool.

Revenue mechanics that matter for OSMOLEX ER

1. Patient incidence limits: CTCL prevalence is small relative to mainstream oncology.
2. Treatment switching: patients may move between systemic CTCL options based on response, tolerability, and comorbidity burden.
3. Dose intensity effects: ER formulations often shift tolerability and adherence, which impacts persistence.
4. Net price sensitivity: high headline pricing for oncology drugs frequently yields large rebate offsets.

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How have OSMOLEX ER market dynamics evolved versus other CTCL therapies?

Answer: OSMOLEX ER competes in a crowded CTCL regimen environment where “best option” shifts with stage, prior therapies, skin-limited burden, and toxicity management. The net effect is stable-to-slow growth at best, with a recurring risk of share erosion when other systemic agents gain formulary access.

Competitive set structure in CTCL

• Other systemic options (contextual substitution risk): retinoids, histone deacetylase inhibitors, targeted agents (where applicable by biology), and immunomodulators.
• Topical and skin-directed therapies: these can reduce systemic starts and preserve OSMOLEX ER for later lines.
• Treatment sequencing: many clinicians reserve systemic therapy for progression or inadequate response to skin-directed approaches.

What pushes demand up or down

Demand tailwinds

• Better tolerability perception from ER dosing versus immediate-release bexarotene.
• Increased systemic use when patients progress beyond skin-directed therapies.

Demand headwinds

• Toxicity management complexity (lipids, thyroid axis effects typical for retinoids).
• Payer and patient cost barriers that slow therapy initiation.
• Pipeline activity in CTCL that can displace systemic retinoids in later-line sequences.

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When does OSMOLEX ER face exclusivity and generic or biosimilar pressure?

Answer: OSMOLEX ER faces generic substitution pressure based on the bexarotene patent and marketing exclusivity landscape and any product-specific exclusivity tied to ER formulation. The presence of a generic in the market materially changes pricing leverage and patient acquisition.

Exclusivity and market-entry levers that govern the risk

• Composition-of-matter patents for bexarotene (originator estate dynamics).
• Formulation patents (ER formulation specifics, if any).
• Method-of-use and dosing regimen patents (less frequently decisive if claims cover broadly use patterns already known).
• Orphan or exclusivity periods (if any apply for the specific product and indication).
• Regulatory pathway behavior: Paragraph IV filings (if any) often accelerate entry by creating settlement-driven “launch windows.”

Generic entry risk framework

• If an approved generic reaches the market, net price erosion begins fast due to specialty pharmacy contracting dynamics.
• If multiple entrants appear, trajectory becomes rapidly price-volume elastic.

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What patents protect OSMOLEX ER and how strong is the patent estate?

Answer: The patent estate strength for OSMOLEX ER depends on whether the relevant claims are still live for: (1) bexarotene composition, (2) extended-release formulation, and (3) any CTCL-specific method-of-use claims.

Current patent estate assessment: Not provided in the prompt context. A complete, accurate “which patents” and “expiration timeline” map cannot be produced without Orange Book listings and specific patent numbers tied to OSMOLEX ER.

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What is the Orange Book status of OSMOLEX ER?

Answer: Orange Book status requires product-specific patent and exclusivity listings. The prompt does not include the Orange Book listing or patent table needed for a complete status readout.

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What generic entry risks exist for OSMOLEX ER and what would happen to revenue?

Answer: A generic entry would likely trigger:

• immediate wholesale acquisition cost resets,
• switching by pharmacy benefit managers and formularies,
• loss of gross-to-net leverage for the branded product,
• and a discontinuous drop in branded TRx driven by contracting and patient co-pay management.

Revenue impact model (directional)

• Short-run: branded stays on formulary initially but gets demoted; net price falls through rebates.
• Mid-run: volume declines accelerate as PBMs implement step edits and prefer low-cost equivalents.
• Long-run: branded revenue stabilizes at a smaller base for patients with prior tolerance, prescriber preference, or payer exception pathways.

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How does OSMOLEX ER compare with alternative bexarotene presentations?

Answer: If an immediate-release bexarotene product exists on the market, ER likely differentiates on tolerability, adherence, and dosing convenience. In practice, substitution risk depends on:

• equivalence acceptance by payers,
• clinician belief about tolerability and lab management,
• and patient-specific tolerability history.

Market behavior under substitution

• Payers often prefer lower-cost equivalents within the same active ingredient class.
• Clinicians may resist switching when ER improves adherence or reduces variability of exposure.

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What financial trajectory has OSMOLEX ER shown historically?

Answer: The prompt does not provide the company filings, segment revenue disclosures, or sales tables necessary to quantify historical revenue, prescription counts, or market share.

What must be true for a measurable trajectory

• Branded product sales are typically disclosed at the company level, often in oncology or specialty categories rather than as a single line item.
• Market share and TRx require IQVIA-level inputs or public audit-like data.

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How does payer coverage shape OSMOLEX ER profitability?

Answer: Profitability is dominated by net price and rebate structure rather than list price, with CTCL being a small population that invites tighter payer controls.

Coverage dynamics

• Prior authorization criteria often focus on diagnosis confirmation and treatment line.
• Dose optimization requirements and lab-monitoring documentation can slow starts.
• Step therapy or formulary tiers can shift prescribing behavior.

Margin pressure pathways

• Contracting that favors lower-cost generics (once available).
• Expanded rebate pressure as competing CTCL systemic options gain in-network status.

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What manufacturing and supply risks affect OSMOLEX ER commercialization?

Answer: Supply risk matters for ER oncology drugs due to limited patient tolerance for delays and the need for stable dosing schedules.

Key supply drivers

• Scale-up reliability for ER capsule fills.
• Logistics resilience for specialty distribution.
• Stability of ER critical process parameters.

What would show up in results

• Short-term lost prescriptions due to backorders.
• Increased service claims and potential payer frustration after chronic delays.

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What litigation or settlement dynamics could influence OSMOLEX ER market entry timing?

Answer: Patent litigation and settlement agreements drive entry timing for generics, often changing the branded product’s revenue runway.

Status in this prompt: not provided. A litigation timeline with case numbers, courts, and settlement dates cannot be constructed without the specific dataset.

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Key Takeaways

• OSMOLEX ER’s market is structurally constrained by CTCL incidence and physician sequencing behavior, limiting addressable volume growth.
• Net price and payer access are the main determinants of financial trajectory; list price is secondary.
• Generic substitution risk is the dominant downside lever; if bexarotene ER or a product-equivalent becomes available, branded revenue typically compresses quickly via PBM contracting and rebate reset.
• A complete view of exclusivity, Orange Book status, patent expiration dates, and Paragraph IV/settlement effects requires the product-specific patent listing and litigation docket inputs, which are not present in the prompt.

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FAQs

1. How does ER dosing vs immediate-release bexarotene affect CTCL persistence and adherence?
2. What payer criteria most often delay OSMOLEX ER starts for CTCL patients?
3. How quickly do branded net prices typically fall after a bexarotene generic enters?
4. Which CTCL competitors most commonly displace systemic bexarotene in later-line sequencing?
5. What Orange Book exclusivities would extend OSMOLEX ER’s revenue runway beyond patent expiration?

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book listings for relevant bexarotene/OSMOLEX products).