DHIVY Drug Patent Profile

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

Dhivy is a drug marketed by Avion Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in six countries.

The generic ingredient in DHIVY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dhivy

A generic version of DHIVY was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28^th, 1992.

Summary for DHIVY

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	55
Drug Prices:	Drug price information for DHIVY
What excipients (inactive ingredients) are in DHIVY?	DHIVY excipients list
DailyMed Link:	DHIVY at DailyMed

See drug prices for DHIVY

Pharmacology for DHIVY

Drug Class

Aromatic Amino Acid

US Patents and Regulatory Information for DHIVY

DHIVY is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for DHIVY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amneal Pharma Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

International Patents for DHIVY

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112020017422
Canada	3095341
China	111954523
European Patent Office	3773532

Supplementary Protection Certificates for DHIVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

DHIVY (dafluprednate) ophthalmic emulsion: Market dynamics and financial trajectory

Last updated: July 29, 2026

DHIVY is an ophthalmic corticosteroid (active ingredient: difluprednate) used to treat ocular inflammation. Public financial disclosure for “DHIVY” specifically is not available in the provided information, so this analysis focuses on the market structure that drives pricing, share, channel economics, and loss-of-exclusivity risk for difluprednate ophthalmics in the U.S. and the related generic-entry calendar typically governing revenue trajectories.

What is DHIVY and how is it positioned in the difluprednate ophthalmic market?

DHIVY is a branded difluprednate ophthalmic emulsion product competing in a small, indication-defined segment of post-surgical ocular inflammation and uveitis care where prescribers value potency, dosing convenience, and formulary access.

Core commercial drivers for difluprednate ophthalmics

• Indication fit: post-operative inflammation (cataract/other surgery), uveitis and related ocular inflammatory conditions.
• Formulary and payer controls: coverage policies and prior authorization often dictate scripts more than clinical nuance, especially once generic alternatives become available.
• Dosing regimen and adherence: difluprednate’s intensive early dosing schedules create friction; brands with easier adherence or preferred contracting can gain share.
• Channel mix: hospital/ASC and retail pharmacy split affects replenishment cadence and rebates.

Competitive landscape snapshot (commercial)

Difluprednate ophthalmics compete primarily against:

• Lower-cost generic difluprednate products (when launched)
• Other steroid ophthalmics (prednisolone acetate, loteprednol, etc.), which compete on formulary preference and step-therapy

How does DHIVY’s pricing and reimbursement typically evolve over a product life cycle?

Revenue trajectory for branded ophthalmic products generally follows a “launch-to-coverage-to-erosion” pattern driven by managed care contracting and generic pressure.

Stage 1: Launch and early coverage

• Commercial objective: maximize early formulary adoption and secure preferred status for common surgical indications.
• Mechanism: rebates and contracting with large pharmacy benefit managers and health plans.

Stage 2: Stable branded period

• Mechanism: brand holds share through contracting despite incremental competitor arrivals.
• Signal: if payer coverage stays favorable and generic entry is delayed, the brand sustains higher net prices.

Stage 3: Generic erosion and margin compression

• Mechanism: generic difluprednate availability (or AB-rated therapeutics) shifts demand toward lower net cost products.
• Outcome: branded net price declines as pharmacy claims migrate; brand revenue often drops disproportionately faster than unit sales due to aggressive rebates and payer switching.

When does DHIVY lose exclusivity, and what are the generic entry timing risks?

Key timing risk is the availability of generic difluprednate and any exclusivity tied to the branded product’s specific filing and formulation claims. In difluprednate ophthalmics, exclusivity timelines are typically determined by:

• New Chemical Entity exclusivity (if applicable to the product’s active ingredient, not usually the driver for older actives)
• New clinical investigations or formulation/dosing exclusivity
• Patent protection in the Orange Book

Because the requested analysis requires patent numbers, listed expiration dates, and Orange Book statuses for “DHIVY,” and no Orange Book listing data was provided in the prompt, a complete exclusivity calendar cannot be produced without risking inaccuracies. Under the constraints, this section is not populated with dates.

What is the Orange Book status of DHIVY and which patents are listed?

An accurate Orange Book status requires the product’s Orange Book entry, including:

• listed drug name variants
• patent numbers
• patent expiration dates
• exclusivity indicators (if listed)

No Orange Book listing details for “DHIVY” were provided. Under the constraints, no patent table or status can be generated.

How strong is the patent estate for DHIVY versus difluprednate competitors?

A defensible “patent strength” assessment needs:

• claim scope (composition, formulation, method of use, manufacturing)
• remaining life across each family
• documented litigation positions and claim constructions

No DHIVY patent estate data was provided. Under the constraints, this section is not populated.

What patent litigation affects difluprednate ophthalmics and could impact DHIVY revenue?

Revenue-impacting events include:

• Paragraph IV ANDA litigation against listed Orange Book patents
• settlements that trigger “carve-outs,” “at-risk launch,” or delayed generic entry
• court rulings narrowing or upholding formulation/method claims

No litigation docket information for “DHIVY” or its listed patents was provided, so the litigation timeline cannot be stated without introducing error.

How do formulation and method-of-use patents typically shape DHIVY’s commercialization risk?

For ophthalmic corticosteroids, formulation and method claims can matter when generics attempt:

• different droplet size, viscosity, or preservative systems
• different dosing frequency schedules for specific indications
• different packaging or delivery system attributes

A claim-by-claim assessment requires the actual listed patent set for “DHIVY.” Without it, no formulation/method barriers can be mapped.

What generic entry risks exist for DHIVY in the U.S. market?

Generic entry risk is driven by three factors:

1. Orange Book patent coverage remaining life
2. Ability to secure regulatory approval (bioequivalence, comparability, and any formulation changes)
3. Litigation outcomes and settlement triggers (launch date certainty)

Because no Orange Book and litigation data for “DHIVY” is provided, the risk assessment cannot be quantified.

How does DHIVY compare with other difluprednate or steroid ophthalmic brands on commercial outcomes?

For accurate competitive comparison, the analysis needs:

• net sales or unit share by product
• payer coverage tiers and rebate rates
• market share movement around generic launches

No DHIVY or competitor financial disclosures were provided. Under the constraints, no comparative market-share trajectory is generated.

Is DHIVY a likely target for biosimilar-like substitution dynamics or is it strictly generics-based?

DHIVY is an ophthalmic corticosteroid small molecule, not a biologic. Substitution dynamics are generics and therapeutics switching, not biosimilar pathways.

What are the financial trajectory benchmarks for ophthalmic steroid products like DHIVY?

Even without product-specific financials, the following benchmarks are typical for ophthalmic steroid branded products transitioning to generic competition:

• Net sales decline often accelerates after generic entry due to pharmacy switching and rebate reconfiguration.
• Gross margin compression follows as branded accounts demand lower effective pricing.
• Marketing spend can fall after share erosion, but may remain elevated if the brand fights to defend key formulary positions.

These are structural benchmarks; they are not numeric DHIVY forecasts.

Key Takeaways

• DHIVY sits in a narrow ophthalmic anti-inflammatory segment where payer coverage, rebates, and generic availability determine revenue shape more than pure clinical positioning.
• A complete market-and-financial trajectory for DHIVY requires Orange Book patent listings, exclusivity indicators, and any Paragraph IV litigation/settlements tied to the product’s entry. None were provided in the input, so those segments are not stated.
• The most material revenue risk is U.S. generic difluprednate entry timing, followed by net price compression and claims migration.

FAQs

1. What market factors determine net price for branded difluprednate ophthalmic emulsions?
2. How do formulary switches change difluprednate ophthalmic unit demand after generic launch?
3. What Orange Book patent types most often drive delays in generic entry for ophthalmic corticosteroids?
4. Do ophthalmic corticosteroid brands rely more on rebates or contracting for durability?
5. What data sources are typically used to track product-level revenue trends in ophthalmology pharmaceuticals?

References

1. FDA Orange Book (Drug Products and Approved Drug Products with Therapeutic Equivalence Evaluations). U.S. Food and Drug Administration. (No specific DHIVY entry cited due to lack of provided listing data.)
2. FDA. ANDA Litigation and Paragraph IV framework (regulatory background). U.S. Food and Drug Administration. (No product-specific docket cited due to lack of provided DHIVY litigation data.)