DORAL Drug Patent Profile

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

Doral is a drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quazepam profile page.

DrugPatentWatch^® Generic Entry Outlook for Doral

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DORAL

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,086
What excipients (inactive ingredients) are in DORAL?	DORAL excipients list
DailyMed Link:	DORAL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAL

NDA:

018708

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for DORAL

DORAL is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987		DISCN	No	No
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985		RX	Yes	Yes

Expired US Patents for DORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985

International Patents for DORAL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	8202659
Canada	1202638	DERIVE D'AMINOALKYLFURANNE (AMINOALKYLFURAN DERIVATIVE)
Switzerland	640846	Aminoalkylfuran derivative
Australia	2751977

DORAL: Market Dynamics and Financial Trajectory

Last updated: April 26, 2026

What is DORAL in the market?

“Doral” is a branded prescription product containing quazepam (benzodiazepine hypnotic) marketed for insomnia. The product is historically associated with later-cycle brand erosion driven by (1) patent/market exclusivity expiry, (2) generic penetration, and (3) regulatory and channel shifts in controlled-substance products.

The market reality for Doral is that it is no longer positioned as a high-growth, protected monopoly asset in most developed markets. Its financial trajectory has been shaped by generic substitution and the general decline in brand pricing power for older small-molecule sleep agents once exclusivities expire.

How does competition shape Doral’s dynamics?

Doral faces competition across three layers:

1. Generic quazepam (direct substitution)
2. Other hypnotics (therapeutic substitution): newer non-benzodiazepine hypnotics and other sleep agents compete for formulary space and prescriber preference
3. Payer utilization management: step edits, prior authorization, and quantity limits in insomnia categories (common for controlled-substance hypnotics)

In practice, direct substitution is the dominant pressure because quazepam is a well-defined molecule and is typically substitutable at the molecule level. That structure compresses pricing and tends to move remaining brand sales into a shrinking niche.

What regulatory and controlled-substance mechanics matter?

Quazepam-based products operate in a controlled-substance framework, which drives:

• Prescriber and dispensing friction relative to non-controlled sleep agents
• Ongoing compliance costs across distribution channels
• Higher sensitivity to guideline and payer scrutiny around benzodiazepine hypnotics

This affects both volume retention and reimbursement stability, especially as payers shift preferred coverage toward newer or more administratively convenient options.

What is the financial trajectory pattern for Doral-like brands?

Doral fits the standard lifecycle profile of older hypnotic brands once generics enter:

• Peak brand sales occur pre-generic entry
• Post-generic entry: rapid unit and revenue decline, with any remaining brand sales concentrated in a smaller customer base (patients stable on brand, clinician preference, limited payer exceptions)
• Late-cycle: brand profitability depends more on cost structure and channel retention than pricing power

The trajectory is typically measured by declining net sales and shrinking contribution margins as wholesalers and pharmacies shift to lower-cost alternatives.

What do the market data sources indicate about Doral’s current position?

Public-facing product identity data aligns Doral with quazepam and places it within standard prescription channels. Market performance depends on jurisdiction-specific generic availability. Under typical market conditions for older benzodiazepine hypnotics, the brand’s competitive position deteriorates after generic entry.

Doral’s molecule-level definition is consistent across regulatory listings, while sales performance is largely governed by generic pricing and payer formularies.

Product identity and molecule attribution

• Doral is quazepam (benzodiazepine hypnotic) [1].

Where does Doral sit across payer behavior and formularies?

For insomnia drugs, payer behavior tends to follow a repeatable pattern:

• Prefer lower acquisition cost options once generic equivalents exist
• Apply step therapy to direct patients away from older classes if clinically acceptable alternatives exist
• Use quantity limits and monitoring requirements to manage controlled-substance exposure

For Doral specifically, generic quazepam availability tends to displace the brand in covered tiers. That reduces the brand’s ability to maintain revenue unless a payer exception persists.

What does this mean for future revenue capacity?

Given the category dynamics:

• Brand revenue headroom is limited by generic substitution
• Volume growth is constrained because molecule-level competition is not only price-based but also formulary-based
• Any residual growth must come from narrow segments (brand continuity, specific prescriber habits, localized reimbursement quirks)

In most markets, this translates into a mature-to-declining revenue profile rather than a cyclical rebound.

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Market dynamics by driver (impact direction and mechanism)

Driver	Likely direction for Doral	Mechanism
Generic quazepam entry	Down	Wholesale and pharmacy substitution to lower-cost molecule
Payer formulary tightening	Down	Lower tiers for older hypnotics once alternatives exist
Controlled-substance friction	Down/flat	Utilization management and compliance requirements
Patient brand stickiness	Flat/down	Smaller remaining population stable on brand
Category innovation (newer sleep agents)	Down	Therapeutic substitution and prescriber preference shifts

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Financial trajectory: what the business curve usually looks like

For a Doral-branded quazepam product, investors and R&D planners should model the financial curve as follows:

1) Short-term: normalization after generic penetration

• Brand pricing compresses quickly
• Net sales fall faster than units because of pricing and reimbursement pressure

2) Medium-term: declining profitability as marketing leverage falls

• Remaining sales become concentrated in lower-velocity channels
• Promotional spend often does not scale revenue meaningfully in generic markets

3) Long-term: residual niche economics

• Brand retains only a small share where substitution barriers exist
• Corporate focus shifts from expanding brand equity to minimizing cash leakage

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What strategic implications follow for R&D and investment decisions?

Doral’s market structure implies that future economic upside from the brand line is structurally capped. For business development and investment screens:

• Treat Doral as a cash-extraction or decline-managed asset, not a growth engine
• Value future opportunity through differentiation elsewhere: new insomnia mechanisms, improved safety or tolerability profiles, or non-benzodiazepine positioning with better payer acceptance
• If evaluating a quazepam program, the economic model depends on whether it can avoid direct generic substitution or win a distinct formulary niche through differentiated delivery, dosing regimen, or claims-driven payer advantages (not the classic brand approach)

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Key Takeaways

• Doral is quazepam, a benzodiazepine hypnotic facing strong generic and formulary substitution pressure [1].
• Market dynamics trend toward brand pricing compression and volume erosion once generics exist.
• Financial trajectory for Doral-like mature hypnotic brands follows a decline-to-niche pattern, with limited growth capacity driven by payer and substitution behavior.
• Business models should treat the brand as late-cycle economics, not a reliable platform for expansion without meaningful differentiation.

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FAQs

1. Is Doral a unique drug in the insomnia market?
   No. Doral is quazepam, which is substitutable at the molecule level and typically faces generic pressure [1].

2. What is the biggest revenue risk for Doral?
   Generic substitution of quazepam, combined with payer formulary displacement, drives rapid brand erosion once available.

3. Does payer behavior affect Doral differently than other insomnia drugs?
   Yes. As a benzodiazepine hypnotic, Doral can face tighter utilization management and greater scrutiny in insomnia categories, especially under controlled-substance rules.

4. Can Doral still maintain some brand sales after generic entry?
   Often, yes, but mainly as a niche: patients and prescribers who remain stable on the brand and localized payer exceptions.

5. What should investors assume about Doral’s growth prospects?
   Growth prospects are usually limited after generic penetration; economic upside generally requires differentiation beyond the traditional brand life-cycle.

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References

[1] FDA. (n.d.). Doral (quazepam) information and listing. U.S. Food and Drug Administration.