EVOCLIN Drug Patent Profile

Which patents cover Evoclin, and when can generic versions of Evoclin launch?

Evoclin is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in EVOCLIN is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evoclin

A generic version of EVOCLIN was approved as clindamycin phosphate by HIKMA on April 25^th, 1988.

Summary for EVOCLIN

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOCLIN

US Patents and Regulatory Information for EVOCLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004		DISCN	Yes	No

International Patents for EVOCLIN

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

Country	Patent Number	Title	Estimated Expiration
Argentina	042906	ESPUMA DE FOSFATO DE CLINDAMICINA SENSIBLE A LA TEMPERATURA Y METODO DE TRATAMIENTO DE ACNE QUE LA UTILIZA
Argentina	082432	ESPUMA DE FOSFATO DE CLINDAMICINA
Australia	2004206769	Clindamycin phosphate foam
Australia	2009235974	Clindamycin Phosphate Foam
Brazil	PI0406905	Espuma de fosfato de clindamicina
Canada	2513773	MOUSSE DE PHOSPHATE DE CLINDAMYCINE (CLINDAMYCIN PHOSPHATE FOAM)

Supplementary Protection Certificates for EVOCLIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322

Last updated: July 27, 2026

EvoClin (Evofloxacin?) Investment Scenario and Patent-Focused Fundamentals Analysis: What to Know for R&D, Licensing, and Market Entry

Executive summary

• No reliable, investable fundamentals can be produced for “EvoClin” without the active ingredient, dosage form/strength, and market (country) of the product. “EvoClin” is a brand-like label used in multiple naming contexts and could map to different drugs or formulations.
• To deliver a complete patent-and-regulatory investment scenario (Orange Book/Biologics, exclusivity windows, generic or biosimilar entry risk, and litigation/settlement exposure), the product identity must be unambiguous. With the current input, any patent estate, FDA status, revenue exposure, and timeline would be speculative.

What is EvoClin’s active ingredient and who makes it (for investment-grade fundamentals)?

A fundamentals model for a branded pharmaceutical depends on a single unambiguous mapping:

• active ingredient (INN/USP/generic name)
• dosage form and strength (tablet, capsule, solution, injection, ophthalmic, topical, etc.)
• manufacturer and labeler (marketing authorization holder)
• jurisdiction (FDA/US, EMA/EU, UK MHRA, India CDSCO, etc.)
• Rx vs OTC classification and indication set

Investment impact

• Patent duration, exclusivity, and generic risk differ radically by molecule, formulation, and route of administration.
• Revenue durability depends on label scope, payer coverage, and whether the molecule faces class-wide substitution.

What makes brand-name mapping critical for IP and exclusivity?

• New chemical entity (NCE) vs line extension: Exclusivity differs by regulatory designation.
• Formulation and method-of-use patents: Drive late-stage generic and “authorized generic” timelines.
• Combination products: Require mapping every component’s patent and regulatory exclusivity hooks.

What patents protect EvoClin and how strong is the patent estate?

A credible “patent strength” assessment requires:

• the Orange Book (or equivalent in target jurisdiction) listing set
• patent family structure: core compound, polymorph/solid state, formulation, stability, device/delivery, and method-of-use
• assignee history and continuation filings
• remaining expiration dates by claim scope

Investment impact

• Licensing and entry models depend on whether the estate is dominated by:
  • a single late-expiring compound patent, or
  • multiple layered formulation/method claims that can delay generic launch even after compound expiry.

Which patent types usually matter most for branded small molecules?

• Composition of matter (compound/analog)
• Polymorph/crystal form or solvates
• Formulation patents (excipients, granulation, coating, controlled release)
• Manufacturing process patents (scale-up, temperatures, purification)
• Method-of-use (dose, patient subset, indication, regimen)

When does EvoClin lose exclusivity in the US, EU, and key markets?

Exclusivity and patent expiry timelines must be computed from:

• FDA exclusivity records (NCE, 3-year, 5-year, pediatric, orphan, etc. as applicable)
• patent expiry dates from Orange Book listings
• any pediatric exclusivity or patent term adjustments (PTA)
• EU: supplementary protection certificate (SPC) and data exclusivity dates

Investment impact

• The earliest feasible generic or biosimilar entry date changes the valuation multiple used in pipeline and commercialization investments.

How to model a generic entry risk timeline

• compound expiry first
• then formulation/method patent barriers
• then Orange Book-listed patent carve-outs that trigger Paragraph IV litigation probability
• then settlement-driven “at-risk” windows

What is the Orange Book status of EvoClin (and what generic entry risks exist)?

For US commercial planning, the Orange Book listing status determines:

• whether there are unexpired patents at the time of filing
• the listed expiration dates and patent numbers
• whether there have been Paragraph IV certifications
• whether litigation has been triggered or stayed via settlement

Investment impact

• Strong estates with multiple unexpired patents usually shift payer/market access leverage and delay cost-down.

What patent certifications typically predict launch outcomes?

• “Paragraph IV” relates to invalidity or non-infringement of a specific Orange Book-listed patent.
• Settlement agreements often create a delayed launch date or market-share tradeoff.

What formulation patents protect EvoClin (and can they block generic substitutes)?

Formulation patents are common late-stage barriers for oral solids, controlled-release products, topical formulations, and specialty routes.

Investment impact

• If EvoClin is a modified-release or stability-sensitive formulation, generic design-arounds can be costly, delaying entry even when compound patents expire.

What to check in a formulation IP review

• controlled release mechanisms (matrix, reservoir, osmotic, enteric coating)
• bioequivalence risk (food-effect, dose dumping, Cmax/AUC targets)
• stability and shelf-life claims tied to packaging and storage
• excipient or processing steps that affect performance

What method-of-use patents protect EvoClin (and who can still market generics)?

Method-of-use claims can preserve branded economics when:

• generics can be approved for alternative indications, or
• method claims are narrowly tied to dosing schedules or patient populations

Investment impact

• If method claims cover a major label segment, branded retention can persist.

How to map method-of-use scope to label reality

• inclusion of specific dose regimens
• patient phenotype, biomarker, or concomitant therapy language
• timing (initiation window) and duration of therapy

What patent litigation affects EvoClin (settlements, stays, and Paragraph IV history)?

An investment-grade view requires:

• dockets and case captions for the relevant district courts
• asserted patents, counterclaims, and injunction outcomes
• stay/accelerations under Hatch-Waxman timelines
• settlement terms that define “design-around” or launch date constraints

Investment impact

• Settlement-driven entry dates materially affect NPV and risk-adjusted returns.

What litigation events usually change fundamentals

• dismissal or invalidation of key claims
• adverse Markman rulings on claim construction
• consent judgments affecting specific product designs

What is the FDA regulatory status of EvoClin (approval history and exclusivity hooks)?

A fundamentals model needs:

• initial approval date and NDA/BLA number
• approval pathway (505(b)(1), 505(b)(2), 505(j))
• label revisions and supplementary NDA history
• exclusivity periods linked to the approval (where applicable)
• current label indication list and boxed warning constraints

Investment impact

• Regulatory history affects both time-to-market for generics and likelihood of future label expansions that sustain revenue.

How to connect regulatory status to revenue durability

• label stability: changes in indication scope can expand TAM or reduce it
• post-marketing requirements: safety signals can trigger brand erosion
• manufacturing changes: can alter generic equivalence and substitution risk

How does EvoClin compare with competing drugs in its class (pricing, access, and IP differentiation)?

A comparative investment view must include:

• mechanism of action and clinical differentiation
• dosing frequency and adherence advantages
• safety profile and real-world tolerability
• payer positioning (preferred status, formulary placement)
• expected generic impact given competitor patent expiry overlap

Investment impact

• IP overlap with class competitors can cause simultaneous price compression, raising volume share risk.

What to include in a competitive IP map

• closest API equivalents or branded competitors
• each competitor’s Orange Book/National equivalents and remaining expiries
• whether class substitution is likely due to equivalent clinical outcomes

Investment scenario: commercialization upside vs. IP and regulatory downside

A complete scenario model typically includes:

• base case: generic entry delayed by multiple Orange Book patents or formulation/method barriers
• downside: early adverse litigation or settlement allows launch
• upside: label expansion or extended lifecycle (line extension approvals)
• risk overlay: manufacturing readiness of generic entrants and sustained bioequivalence hurdles

Investment impact

• Without product identity, no credible scenario can be parameterized.

Key metrics investors use for branded pharma fundamentals (product-agnostic template)

When the product is identified, the model should be populated with:

• peak sales and current run rate (US and target geography)
• gross-to-net drivers (rebates, discounts, government pricing)
• payer coverage and channel mix
• inventory and supply stability signals
• patent expiries and exclusivity windows mapped to generic entry probabilities
• litigation timeline and settlement status
• manufacturing dependency risk (single-source API or critical intermediates)
• evidence of real-world adoption (claims data proxies)

Key Takeaways

• A complete investment and patent fundamentals analysis for “EvoClin” cannot be generated from the provided information without mapping the brand to its active ingredient, dosage form/strength, and jurisdiction.
• IP and exclusivity timelines, Orange Book status, Paragraph IV risk, and litigation exposure are product-specific and cannot be stated reliably at brand level.

FAQs

1. How does Orange Book listing status determine whether generic launch is “at risk” for a specific branded product?
2. What types of patents most commonly delay generic entry: compound, formulation, method-of-use, or manufacturing-process patents?
3. How do settlement agreements in Hatch-Waxman cases change the effective launch date versus the statutory exclusivity end date?
4. What regulatory pathway differences (505(b)(1) vs 505(b)(2) vs 505(j)) most affect exclusivity and generic approval timing?
5. How should investors weight PTA, pediatric exclusivity, and SPC effects when modeling exclusivity in the US vs EU?

References

(No references provided because no product-specific sources could be reliably tied to “EvoClin” from the input.)