SYMPAZAN Drug Patent Profile

When do Sympazan patents expire, and when can generic versions of Sympazan launch?

Sympazan is a drug marketed by Assertio Speclty and is included in one NDA. There are three patents protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sympazan

A generic version of SYMPAZAN was approved as clobazam by AMNEAL on October 22^nd, 2018.

Summary for SYMPAZAN

International Patents:	9
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Drug Prices:	Drug price information for SYMPAZAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMPAZAN
What excipients (inactive ingredients) are in SYMPAZAN?	SYMPAZAN excipients list
DailyMed Link:	SYMPAZAN at DailyMed

See drug prices for SYMPAZAN

Pharmacology for SYMPAZAN

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No			Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes			Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No			Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No			Y

Expired US Patents for SYMPAZAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018

International Patents for SYMPAZAN

See the table below for patents covering SYMPAZAN around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112021004053	composições de filme oral e formas de dosagem tendo perfis de dissolução de ativo precisos
Canada	3110997	COMPOSITIONS DE FILM ORAL ET FORMES POSOLOGIQUES AYANT DES PROFILS DE DISSOLUTION ACTIFS PRECIS (ORAL FILM COMPOSITIONS AND DOSAGE FORMS HAVING PRECISE ACTIVE DISSOLUTION PROFILES)
China	112955124	具有精确的活性物溶出谱的口腔膜组合物和剂型 (ORAL FILM COMPOSITIONS AND DOSAGE FORMS HAVING PRECISE ACTIVE DISSOLUTION PROFILES)
China	120789028	具有精确的活性物溶出谱的口腔膜组合物和剂型 (Oral film compositions and dosage forms with precise active dissolution profiles)

Last updated: June 2, 2026

SYMPAZAN Market Dynamics and Financial Trajectory: Revenue, Exclusivity, Competition, and Key Patent/IP Risks

SYMPAZAN’s financial and market trajectory is driven by (1) the regulatory and payer pathway for its active ingredient and indication, (2) product lifecycle timing tied to patent and exclusivity events, and (3) competitive pricing pressure from generics and therapeutically similar products. This is a business-led outcome model: demand formation first, then reimbursement and cost-competitiveness, then IP-driven entry barriers.

What is SYMPAZAN’s commercial profile and how do sales typically evolve?

Featured snippet answer: SYMPAZAN’s commercial trajectory generally follows the standard branded pharma curve: ramp post-launch, peak as coverage broadens, then flatten and decline when lower-cost alternatives penetrate.

What drives uptake for a specialized branded product?

Commercial adoption for niche or indication-specific drugs is usually determined by:

• Payer coverage: formulary status, prior authorization requirements, and step therapy.
• Site of care: hospital outpatient vs specialty pharmacy vs retail.
• Clinical differentiation: dosing convenience, safety/tolerability, and outcomes in the labeled population.
• Prescriber concentration: specialty physician networks and guideline alignment.

How do price and net revenue diverge from list price?

For most pharma products, net sales reflect:

• Rebates and patient assistance program outflows tied to payer and channel mix.
• Contracted pricing that shifts sharply after first generic/therapeutic competitor entry.
• Seasonal or indicator-specific demand volatility.

What is the Orange Book status of SYMPAZAN and what does it imply for future generic entry?

No complete Orange Book patent/exclusivity dataset is available in the provided information to determine:

• listed patents (drug substance, formulation, method-of-use)
• expiration dates and patent “reach-through” terms
• exclusivity periods (3-year, 5-year, pediatric, orphan, etc.)
• whether any ANDA Paragraph IV certifications exist

When does SYMPAZAN lose exclusivity and what timing risks matter for revenue?

A correct exclusivity and generic-entry timing model requires the actual SYMPAZAN FDA exclusivity end dates and Orange Book patent expiration dates. Those are not present in the provided information. Without them, any launch-window or “first generic date” construct would be inaccurate.

Which companies are challenging SYMPAZAN with Paragraph IV ANDAs, and how do settlements shape pricing?

A Paragraph IV challenge and settlement footprint is needed to map:

• filer identities
• court filing dates and outcomes
• 30-month stay triggers
• authorized generic or “launch-at-risk” pathways
• revenue impact windows from first allowed entry

No such litigation/challenge data is provided.

How strong is the patent estate for SYMPAZAN: which patent types protect sales?

A strength assessment requires the patent family inventory and claims coverage map for:

• active ingredient composition-of-matter
• formulation/dosage form (including specific excipients or solid-state forms)
• method-of-use (indication-specific claims)
• manufacturing/process claims
• combination or regimen claims, if applicable

No patent numbers, assignees, jurisdictions, or claim categories are provided.

How do formulation and method-of-use patents affect launch risk?

Even with composition-of-matter expiration, a product can remain protected by:

• formulation-specific claims that block simple generic replication
• method-of-use claims that force “carve-out” labeling
• REMS or safety-related labeling that changes generic viability

No SYMPAZAN formulation/method-of-use patent data is provided.

What competitive landscape will drive financial pressure on SYMPAZAN?

A defensible competitive landscape needs:

• labeled indication overlap
• therapeutically similar agents and dosing schedules
• competitor net price and payer placement
• generic/biologic substitution likelihood

No competitor list, indication mapping, or pricing data is included in the provided information.

How does SYMPAZAN compare with competing drugs on lifecycle, pricing, and reimbursement?

A valid comparison must include at least:

• launch year and major payer milestones
• net price trajectory (or benchmarked price indices)
• formulary penetration timing
• anticipated generic entry dates for each comparator

Those inputs are not present.

What manufacturing and IP barriers exist for SYMPAZAN generics?

Manufacturing/IP barriers depend on:

• specialized manufacturing steps in the patent portfolio
• proprietary intermediates or critical process parameters
• need for specific particle size/solid-state properties
• validated analytical methods tied to claimed specs

No manufacturing/IP specifics for SYMPAZAN are provided.

Key regulatory milestones affecting SYMPAZAN revenue: FDA pathway, labeling changes, and exclusivity extensions?

A revenue-impacting regulatory timeline must be built from:

• FDA approval date(s)
• supplements and labeling expansions
• REMS changes, if any
• exclusivity grants (including pediatric or orphan, if applicable)

No SYMPAZAN FDA milestone list is provided.

Key Takeaways

• SYMPAZAN’s market dynamics are determined primarily by payer uptake, pricing and net revenue compression mechanics, and IP-driven entry barriers.
• A precise financial trajectory and “when generics arrive” timeline requires Orange Book listings, FDA exclusivity terms, and any Paragraph IV litigation or settlement history. These data are not provided, so a complete, accurate market-entry and revenue-loss model cannot be produced from the current inputs.

FAQs

1. Does SYMPAZAN face immediate generic substitution risk after branded approval?
2. What payer restrictions most influence SYMPAZAN net sales?
3. How do labeling carve-outs change generic viability for SYMPAZAN?
4. What litigation outcomes most affect SYMPAZAN expected revenue decline timing?
5. Which factors determine whether an authorized generic will be launched for SYMPAZAN?

References

No sources were provided in the prompt.