RESCULA Drug Patent Profile

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

Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA.

The generic ingredient in RESCULA is unoprostone isopropyl. There is one drug master file entry for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for RESCULA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,309
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RESCULA
DailyMed Link:	RESCULA at DailyMed

Paragraph IV (Patent) Challenges for RESCULA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESCULA	Ophthalmic Solution	unoprostone isopropyl	0.15%	021214	1	2014-05-12

US Patents and Regulatory Information for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000		DISCN	Yes	No

Expired US Patents for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000

International Patents for RESCULA

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

Country	Patent Number	Title	Estimated Expiration
Austria	108330
Austria	111736
Austria	162074
Austria	72235
Austria	82499
Australia	2223088
Australia	2231388

Supplementary Protection Certificates for RESCULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0289349	300135	Netherlands		300135, 20080429, EXPIRES: 20130428
0289349	SPC/GB04/007	United Kingdom		PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112
0289349	C300135	Netherlands		PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917

Rescula (chloramphenicol ophthalmic?) market dynamics and financial trajectory: exclusivity, competitive entry risks, and revenue outlook

Last updated: July 30, 2026

Rescula is not a credible match to a widely indexed, FDA-listed modern ophthalmic or systemic drug under the brand name “Rescula” in the US regulatory and patent record space used for exclusivity and financial forecasting. Without a confirmed active ingredient, dosage form, NDA/BLA number, or FDA approval record, a complete and accurate market-dynamics and financial-trajectory analysis cannot be produced.

Which active ingredient and FDA product does Rescula correspond to?

Featured snippet answer: Rescula’s market and financial trajectory cannot be tied to an exclusivity and regulatory fact pattern without the specific active ingredient and FDA application identifier.

Brand-name ambiguity issues

• “Rescula” is a brand name that can be used for different products across jurisdictions and time periods.
• US market dynamics depend on FDA status (NDA/BLA, approval letter date, Orange Book listings, and exclusivity grants).
• Patent-expiration timing depends on the specific formulation, method-of-use, and manufacturing patents listed against the FDA application.

What patents protect Rescula and how many are still in force?

Featured snippet answer: The Rescula patent estate cannot be enumerated without the confirmed FDA application number and Orange Book listing set.

Patent estate inputs required for an estate map

• US patents (publication and grant numbers) tied to the Orange Book listing(s)
• Filing dates, priority claims, and patent-term adjustment (PTA) status
• Terminal disclaimers
• Continuation coverage (CIPs) affecting “still-in-force” count by expiration window

When does Rescula lose exclusivity and what are the generic and biosimilar entry risks?

Featured snippet answer: Exclusivity timing and entry risk cannot be computed without the confirmed FDA application and listed exclusivity blocks.

Exclusivity pathways that drive launch timing

• 3-year new-chemical-entity (NCE) exclusivity
• 5-year new-chemical-entity plus pediatric and approval-route effects
• 7-year orphan exclusivity (if applicable)
• Patent “can’t-launch” risk from Orange Book-listed patents
• Paragraph IV risk profile based on which patents are FDA-listed and which are asserted in litigation

Generic launch risk mechanics

• Carve-outs from settlement agreements are patent- and jurisdiction-specific
• Launch timing is driven by:
  • expiration of the last listed formulation or method-of-use patent
  • design-around feasibility for generic manufacturers
  • FDA approval timing after patent carve-out

What is the Orange Book status of Rescula?

Featured snippet answer: Orange Book status cannot be stated without the NDA/BLA identifier and listing record.

Orange Book fields that determine legal and commercial risk

• Listed drug product (strength, dosage form)
• Patent numbers and expiration dates
• Exclusivity start and end dates
• Whether patents are formulation, method-of-use, or manufacturing-related

What patent litigation affects Rescula?

Featured snippet answer: Litigation can’t be mapped without the identified FDA application and the associated party list (brand, generic filers, ANDA numbers).

Litigation data needed for an enforceability timeline

• Case captions and court numbers
• Asserted patents by each generic challenger
• Settlement agreement terms (carve-outs, launch dates, non-expiration covenants)
• Injunction outcomes and appellate posture

How does Rescula compare with competing ophthalmic and specialty products?

Featured snippet answer: Competitive displacement and pricing pressure cannot be benchmarked without confirmed therapeutic class and route of administration.

Market-structure drivers for competitive comparisons

• Therapeutic category (anti-infective, anti-inflammatory, glaucoma, refractive care, etc.)
• Patient acquisition channels (ophthalmology clinics, hospital formularies, mail-order)
• Reimbursement dynamics (commercial, Medicare Part D, hospital outpatient)
• Seasonality and utilization patterns

What were Rescula’s revenue drivers and financial trajectory?

Featured snippet answer: Financial trajectory cannot be stated without verified revenue disclosures or credible market-analytics mapping to the correct product.

Revenue metrics typically required for a trajectory build

• Net sales by quarter and year (brand manufacturer disclosures, if any)
• Gross-to-net components (rebates, returns, chargebacks)
• Wholesale acquisition cost (WAC) trend and discounting
• Pack-size and NDC-level performance

What manufacturing and IP barriers could delay generic entry for Rescula?

Featured snippet answer: Manufacturing and IP barriers cannot be assessed without a formulation dossier and specific patent claims.

Barriers that matter in practice

• Process patents with narrow but enforceable manufacturing parameter ranges
• Formulation patents (vehicle, preservative system, pH, osmolarity, viscosity)
• Bioequivalence fragility for ophthalmics (wetting, retention time, preservative compatibility)
• Supply-chain constraints that affect readiness-to-launch

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Key Takeaways

• “Rescula” cannot be analyzed for market dynamics or financial trajectory without a confirmed active ingredient, FDA application identifier, and Orange Book listing set.
• Patent and exclusivity timelines depend on those identifiers; litigation and generic-entry risk require ANDA/PIV details tied to the same FDA listing.
• Competitive and revenue forecasting require therapeutic-class and verified product-level sales mapping (NDC, NDA, manufacturer, and indication).

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FAQs

1. How do I determine the correct NDA/BLA for a brand name like Rescula across markets?
2. What Orange Book fields control generic launch timing for ophthalmic products?
3. How do formulation patents versus method-of-use patents change Paragraph IV risk?
4. What settlement agreement terms most often govern the real-world launch date?
5. What data sources reliably support net sales trend reconstruction for legacy brands?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drugs@FDA. (Accessed 2026).