BYFAVO Drug Patent Profile

Which patents cover Byfavo, and what generic alternatives are available?

Byfavo is a drug marketed by Acacia and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-four countries.

The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this compound. Additional details are available on the remimazolam besylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Byfavo

Byfavo was eligible for patent challenges on October 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BYFAVO

International Patents:	53
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	12
Patent Applications:	51
Drug Prices:	Drug price information for BYFAVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYFAVO
What excipients (inactive ingredients) are in BYFAVO?	BYFAVO excipients list
DailyMed Link:	BYFAVO at DailyMed

See drug prices for BYFAVO

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

NDA:

212295

Dosage:

POWDER;INTRAVENOUS

^*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.

Recent Clinical Trials for BYFAVO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts Eye and Ear Infirmary	PHASE4
Eagle Pharmaceuticals, Inc.	PHASE4
Fred E, Shapiro	PHASE4

See all BYFAVO clinical trials

Paragraph IV (Patent) Challenges for BYFAVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYFAVO	Powder for Injection	remimazolam besylate	20 mg/vial	212295	1	2024-10-07

US Patents and Regulatory Information for BYFAVO

BYFAVO is protected by eleven 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
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes			Y
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes

International Patents for BYFAVO

When does loss-of-exclusivity occur for BYFAVO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

United Kingdom

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

See the table below for additional patents covering BYFAVO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011328497
China	103347519
Denmark	2637662
Eurasian Patent Organization	024926

BYFAVO (fuzed-lurated? no) market dynamics and financial trajectory: pricing, growth, exclusivity, and competitive risk

Last updated: June 19, 2026

BYFAVO (intranasal diazepam; brand name “BYFAVO”) is a niche, high-intensity acute-episode product positioned against rectal diazepam and rescue benzodiazepine standards. Commercial trajectory is driven by (1) neurology, epilepsy, and rescue-care purchasing behavior; (2) payer adoption of intranasal rescue formats; and (3) channel capacity and formulary leverage after launch. Patent and regulatory fences, including Orange Book exclusivity timing and method-of-use/formulation IP, govern how quickly generic or alternative intranasal rescue entrants can price-disrupt the category.

How fast is BYFAVO growing and what does its financial trajectory look like?

BYFAVO’s financial path is typically characterized by early uptake in targeted settings (neurology clinics, hospitals with seizure-rescue protocols, and specialty pharmacy distribution) followed by incremental share gains as formularies convert from rectal diazepam to intranasal rescue.

What are the main revenue drivers for BYFAVO?

• Episode-based demand: Rescue benzodiazepine use is episodic, not chronic, so revenue tracks diagnosis prevalence, caregiver readiness programs, and protocol adoption rather than long-duration persistence.
• Formulary conversion: Market share expands when payers cover intranasal diazepam without restrictive prior authorization or step edits.
• Site-of-care mix: Intranasal formats can increase utilization in settings that avoid rectal administration barriers (patient preference, caregiver training, reduced stigma).
• Distribution mechanics: Specialty and large pharmacy networks determine whether scripts convert into shipped demand and patient access.

What financial metrics should be monitored?

• Net sales vs. script volume (rescue therapies are sensitive to utilization management)
• Gross-to-net pressure (rebates, copays, and payer contracting)
• Channel inventory (risk of pull-through volatility around formulary updates)

What market dynamics shape BYFAVO pricing, access, and uptake?

BYFAVO competes in the acute seizure rescue segment where therapeutic equivalence is driven by delivery form, caregiver usability, and dosing speed. Market behavior is less about incremental clinical superiority and more about route-of-administration acceptance and payer coverage.

Why intranasal matters versus rectal diazepam and other rescues?

• Intranasal administration reduces caregiver handling complexity.
• It can improve time-to-treatment workflows in community settings.
• It aligns with payers’ willingness to cover newer delivery technologies when medical policy supports equivalent rescue efficacy.

What are the payer and utilization management dynamics?

• Prior authorization is a recurring gate for rescue benzodiazepines, especially where payers can point to older, cheaper alternatives.
• Step therapy can delay intranasal adoption if rectal products are preferred as “first-line rescue.”
• Copay cards and patient assistance can drive faster adoption, but increase gross-to-net volatility.

What patents protect BYFAVO and how strong is the patent estate for intranasal diazepam?

The competitive timetable for generics or alternative intranasal diazepam products depends on the breadth of Orange Book-listed patents (drug substance, drug product, and method-of-use) tied to BYFAVO and the associated listed active ingredient.

What patent categories typically block generic entry for BYFAVO?

• Drug product patents: Intranasal formulation specifics, including excipients, particle/solution characteristics, stability, and delivery performance.
• Method-of-use patents: Indications or dosing regimens for seizure rescue contexts.
• Manufacturing process patents: Steps that affect dose uniformity, concentration control, and spray characteristics.
• Device or delivery system claims: If the intranasal administration system is part of the claimed product.

How does patent strength translate into generic risk?

• Broad formulation and method-of-use protection slows Paragraph IV strategies.
• Narrow claims still matter because at-risk launch timing can trigger injunction leverage, even when generic technical design-arounds exist.

When does BYFAVO lose exclusivity and when do generic and biosimilar risks accelerate?

Exclusivity timing determines when competitors can pursue ANDA approvals or launch without breaching Orange Book-protected claims. For branded rescue therapies, “near-terms” are usually when:

1. regulatory exclusivity ends, and
2. Orange Book-listed patents expire or become non-infringed.

What to track on the exclusivity timeline

• Orange Book drug product and method-of-use patent expiration dates
• Regulatory exclusivity windows tied to New Chemical Entity, New Clinical Investigation, or pediatric exclusivity (if applicable)
• Any listed patent term adjustments that move expiration

What is the Orange Book status of BYFAVO and what does it mean for Paragraph IV challenges?

Orange Book status is the practical map for generic challengers. A dense set of listed patents increases the probability of multi-patent Paragraph IV filings and settlement complexity. Sparse listings can reduce barriers and shorten the path to at-risk entry.

How to interpret Orange Book listings for BYFAVO

• Number of listed patents by category: more listings often means more litigation hooks.
• Remaining life of each patent family: challengers time their filings against the longest tail.
• Which patents are “usually targeted”: product formulation and method-of-use are frequently used in ANDA carveouts.

Which companies are challenging BYFAVO and what patent litigation affects market entry?

Generic launch risk for BYFAVO is tied to whether ANDA applicants file Paragraph IV certifications against Orange Book patents and whether they reach settlements that set launch dates.

What litigation outcomes change the market timeline?

• Automatic stays after Paragraph IV filings (where statutory)
• Court-ordered injunctions that block launch until patent expiry or claim narrowing
• Settlement agreements that establish a negotiated launch date and “carve-out” obligations

How does BYFAVO compare with competing acute seizure rescue therapies?

The relevant comparator set includes other rescue benzodiazepines using different delivery routes, and adjacent rescue options used by neurology and emergency protocols.

Key competitive dimensions

• Delivery route acceptance: intranasal vs rectal
• Dosing speed and caregiver usability
• Payer coverage and prior authorization burden
• Total cost of episode: includes copays, administration training, and denied-claims drag

What share shifts are most likely?

• Preferential formulary placement for intranasal rescue in patient populations with caregiver administration needs.
• Gradual substitution where rectal products face adherence and acceptance barriers.

What generic entry risks exist for BYFAVO?

Generic entry risks depend on (1) the claim landscape around formulation and device delivery system, (2) whether challengers can design around without losing bioavailability or spray characteristics, and (3) the litigation and settlement posture that typically governs at-risk launch.

Typical entry pathways that threaten price integrity

• ANDA-to-launch after patent expiry if no injunction remains
• At-risk launch following an adverse legal posture or a settlement window
• Retail and specialty channel stocking if payers update formularies in response to price competition

What market behavior follows successful generic launch?

• Rapid list price discounting, followed by rebate and copay realignment
• Increased payer utilization of lower-cost options
• Brand revenue compression, usually most visible in net sales rather than script counts due to pricing/rebate pressure

What manufacturing and IP barriers could delay BYFAVO competition?

Intranasal products face development and scale constraints: spray performance, stability, and dose uniformity. Even with legal allowance, manufacturing hurdles can delay credible commercial supply.

Practical barriers that slow entrants

• Spray/delivery performance testing and batch reproducibility
• Stabilization of diazepam and formulation excipients under storage constraints
• Consistent dosing per actuation and device compatibility

Commercial trajectory by scenario: no launch delay vs. delayed entry

BYFAVO’s financial trajectory can be modeled around two broad cases used in competitive planning for rescue therapies.

Scenario 1: Limited competition for near-term window

• Higher net retention as formulary access tightens around intranasal rescue
• Revenue growth supported by protocol adoption rather than price cuts

Scenario 2: Accelerated generic or alternative intranasal entry

• Net sales pressure via rebate expansion and payer switching
• Faster erosion if competitors obtain favorable formulary position at launch

What revenue exposure does BYFAVO face across geographies and channels?

U.S. is the primary revenue driver because BYFAVO is tied to FDA approval and Orange Book mechanics. Channel exposure matters because hospital and specialty pharmacy demand can reprice rapidly after formulary shifts.

Channel-level exposure to competition

• Retail pharmacy: sensitive to copay and payer contract changes
• Hospital/clinic purchasing: sensitive to protocol standardization and group purchasing organization leverage
• Specialty pharmacy: sensitive to patient assistance and payer navigation

Key Takeaways

• BYFAVO’s market dynamics are driven by intranasal rescue adoption, payer coverage behavior, and episode-based utilization rather than chronic therapy persistence.
• Competitive risk accelerates when Orange Book exclusivity and listed patent lifetimes approach expiry, with Paragraph IV challenges and settlements shaping the actual launch timetable.
• Financial trajectory depends on net price retention (rebates and copays), formulary conversion from rectal standards, and the timing of generic disruption after patent fences fall.

FAQs

1. What delivery-form advantages most influence payer coverage decisions for intranasal diazepam rescue products?
2. How do Orange Book-listed method-of-use patents affect ANDA approval timing for seizure rescue drugs?
3. What are the typical settlement structures for Paragraph IV challenges in acute neurologic rescue categories?
4. How does hospital formulary standardization change the adoption curve for intranasal rescue benzodiazepines?
5. What manufacturing or device-related development risks most often delay intranasal generic launches even after legal clearance?

References

1. FDA Orange Book. (n.d.). Drugs@FDA / Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Paragraph IV and ANDA-related regulatory guidance and resources. U.S. Food and Drug Administration.