ATRALIN Drug Patent Profile

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

Atralin is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atralin

A generic version of ATRALIN was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for ATRALIN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ATRALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	AB	RX	Yes	Yes

International Patents for ATRALIN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2014437
Hungary	902444
Japan	H032118	HUMECTANT EXCIPIENT FOR TOPICAL APPLICATION OF VITAMIN A ACID
Israel	93928
Australia	633892
Czechoslovakia	9001911
African Intellectual Property Organization (OAPI)	9739

Supplementary Protection Certificates for ATRALIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718

ATRALIN Market Analysis and Financial Projection

Last updated: April 25, 2026

Is ATRALIN investable based on patent and commercial fundamentals?

Answer: ATRALIN is not investable on a near-term IP and commercialization basis using only public, FDA-facing inputs. The product has been marketed for years, and the investable value driver in small-molecule topical dermatology typically hinges on active exclusivity (primary patent term, pediatric exclusivity, NDA data protection, and later-expiring method-of-use or formulation patents). For ATRALIN, the available FDA-facing and product-identification signals do not support a defendable, time-bound exclusivity window that would justify a fresh, high-risk R&D or late-stage acquisition investment as of the current market cycle.

What is ATRALIN and how is it used commercially?

ATRA LIN is a topical acne therapy containing tretinoin (a retinoid). It is marketed in the United States as a dermatologic product for acne, typically in lotion/gel/cream formats depending on label and strength.

Commercial implication: Tretinoin for acne is a mature therapeutic category with established manufacturing and multiple generic offerings over time. Investment underwriting therefore depends on whether ATRALIN maintains any meaningful remaining exclusivity (new chemical entity, new formulation, or method-of-use IP) or a differentiated regulatory pathway that preserves share against generics.

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What does the patent situation imply for exclusivity-driven returns?

Apt commercial returns in branded dermatology formulations depend on:

1. Primary composition-of-matter protection for the active ingredient or a novel prodrug/derivative (rare for legacy tretinoin).
2. Formulation, delivery system, particle engineering, or vehicle IP with remaining term.
3. Method-of-use claims tied to dosing regimens that are difficult to design around.
4. Regulatory exclusivity that blocks generic approval pathways even if composition IP is weak.

For ATRALIN, the investable conclusion is driven by category maturity and the absence of a demonstrable, time-bounded exclusivity moat from public FDA-facing product identity signals. In practice, this means generic erosion is expected as regulatory and patent barriers age out, turning the branded asset into a distribution and brand-cost game rather than an IP-led return.

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How does regulatory structure affect generic pressure for ATRALIN?

For established topical acne therapies, ANDAs can usually rely on:

• Prior reliance on the active ingredient with established pharmacology.
• Bioequivalence where applicable for semisolid topicals.
• Manufacturer changes in excipients and vehicles that fit within the design-around space.

Investor impact: When a brand has aged without clearly documented remaining exclusivity hooks, generic entrants compress price quickly. That compresses gross margins and raises the probability that any incremental clinical or formulation spend cannot recoup.

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What are the revenue and margin fundamentals likely to look like in a mature tretinoin topical segment?

Given the therapy’s legacy status and typical competitive structure:

• Revenue trajectory: tends to decline post-generic entry through either unit erosion (share loss) or price compression.
• Gross margin: often falls due to lower net price and higher promotional costs to defend share.
• Sustained investment case: requires either (a) a new protected formulation (with a clear remaining term), or (b) a protected line extension with distinct IP.

Without a clearly evidenced remaining exclusivity window, ATRALIN’s fundamentals map to a mature branded asset profile rather than a growth or defensible cash-cow investment.

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What does this mean for R&D strategy tied to ATRALIN?

For an investor evaluating a program “around” ATRALIN, the defensible pathways are limited:

• Line extension only if protected: New combination products or vehicle-formulation changes require enforceable claims and remaining term.
• New clinical claims only if patent-linked: Safety or efficacy claims that do not map to extant IP do not create durable exclusivity.
• Regulatory exclusivity is unlikely: For legacy tretinoin, the regulatory exclusivity levers are generally exhausted or not aligned with new topical indications without clear new clinical data packages.

Bottom line: The risk-adjusted return for fresh ATRALIN-centric R&D is weak unless tied to a demonstrably remaining patent estate or a clear new regulatory exclusivity pathway.

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Investment framework: how ATRALIN scores on core criteria

Patent defensibility and timing

Criterion	What matters	ATRALIN implication
Composition-of-matter	Remaining term on active ingredient or protected derivative	Unfavorable for new investment since tretinoin is legacy and composition protection is typically long expired
Formulation/delivery	Remaining formulation patents with vehicle or release mechanics	No evidenced, time-bounded moat from public-facing product identification signals
Method-of-use	Remaining claims tied to a hard-to-design-around dosing regimen	Not evidenced as a near-term enforceable barrier
Exclusivity	Regulatory exclusivity blocks ANDA entry	Not evidenced as active in a way that would preserve branded economics

Market structure and competitive dynamics

Criterion	What matters	ATRALIN implication
Generic pressure	Speed and scale of ANDA launches post-barrier	High probability of ongoing erosion in a mature topical category
Price/margin	Net price vs promotional intensity	Likely downward pressure on net price and margin
Differentiation	Brand-only differentiation vs IP-led differentiation	Hard to sustain without protected formulation or combination

Capital efficiency and execution risk

Criterion	What matters	ATRALIN implication
Clinical upside	Need for differentiated endpoints tied to exclusivity	Weak unless tied to new IP and a clear exclusivity strategy
Chemistry/CMC	Vehicle changes and stability for semisolids	Costly without a durable exclusivity payoff
Timeline	Years to enforceable barriers	Long timelines are misaligned with mature-category generic dynamics

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Actionable conclusion for business and investment decisions

ATRA LIN does not screen as an investable branded dermatology asset on IP-led fundamentals in the current cycle. The investment thesis would require a defendable remaining exclusivity estate (composition, formulation, or method-of-use) that is not supported by the available public FDA-facing product identity signals that typically anchor exclusivity underwriting for topical tretinoin brands.

Investment posture:

• Avoid pure “branded ATRALIN” acquisition or R&D expansion bets unless underwritten by a verified, remaining protected patent estate that directly blocks generic substitution.
• If the strategy is portfolio-based, ATRALIN should be treated as a mature distribution asset, not a growth driver. Any re-investment should be justified by line-extension IP and a documented, enforceable exclusivity runway.

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Key Takeaways

• ATRA LIN is a legacy topical tretinoin acne therapy, placing it in a mature category where generic erosion is structurally likely.
• A defensible, time-bounded exclusivity moat is not evidenced from public FDA-facing product identification signals required for exclusivity-led return underwriting.
• Fundamentals skew toward price and margin compression, unless a verified remaining patent estate supports a line-extension or formulation differentiation.
• R&D capital efficiency is weak unless tied to enforceable IP with meaningful remaining term.

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FAQs

1) What drives returns for branded topical acne products like ATRALIN?

Returns depend on remaining patent exclusivity (composition, formulation vehicle, or method-of-use) and regulatory barriers that delay generic substitution.

2) Why is ATRALIN harder to underwrite than newer dermatology launches?

Because tretinoin is legacy, the critical question becomes whether remaining exclusivity exists; absent that, generic competition compresses net price quickly.

3) Can a formulation change restore exclusivity value for ATRALIN?

It can, but only if the formulation has enforceable patents with remaining term and if the company can tie differentiation to a protected vehicle or delivery mechanism.

4) Is method-of-use IP realistic for topical tretinoin?

It is possible, but it must be clearly claim-supported and enforceable with remaining term that blocks generics using the same regimen.

5) How should an investor treat ATRALIN in a broader portfolio?

Treat it as a mature branded distribution/brand-maintenance asset unless there is a verified, remaining exclusivity runway for line extensions.

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References

[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (U.S. Food and Drug Administration). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA Drug Labeling (DailyMed). (U.S. National Library of Medicine). https://dailymed.nlm.nih.gov/