ALTRENO Drug Patent Profile

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

Altreno is a drug marketed by Dow Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Altreno

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

Summary for ALTRENO

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	2
Drug Prices:	Drug price information for ALTRENO
What excipients (inactive ingredients) are in ALTRENO?	ALTRENO excipients list
DailyMed Link:	ALTRENO at DailyMed

See drug prices for ALTRENO

Recent Clinical Trials for ALTRENO

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

Sponsor	Phase
Ortho Dermatologics	Phase 4
Beth Israel Deaconess Medical Center	Phase 4
Goldman, Butterwick, Fitzpatrick and Groff	Phase 4

See all ALTRENO clinical trials

Pharmacology for ALTRENO

Drug Class

Retinoid

US Patents and Regulatory Information for ALTRENO

ALTRENO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes			Y
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes

Expired US Patents for ALTRENO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018

International Patents for ALTRENO

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

Country	Patent Number	Title	Estimated Expiration
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO
Brazil	112020020431	composições farmacêuticas tópicas para tratamento de condições de pele
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)

Supplementary Protection Certificates for ALTRENO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
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	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	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323

Altèreno (tretinoin) topical gel: market dynamics and financial trajectory (U.S. launch, exclusivity, competitive pressure, and revenue outlook)

Last updated: July 25, 2026

Altèreno (tretinoin) is a prescription dermatology product built around a proprietary topical formulation strategy targeting acne vulgaris (local skin disease). Public financial reporting for the branded product is limited, but the U.S. market dynamics are driven by (1) cadence of generic and authorized-available entry risk in topical tretinoin, (2) insurer and channel preferences shaped by formulary placement and rebates, and (3) the longevity of formulation and method-of-use patent coverage tied to the Altèreno platform.

What is Altèreno (tretinoin) and what market does it compete in?

Altèreno is a topical tretinoin product indicated for treatment of acne vulgaris. It competes within the U.S. prescription acne therapy landscape that includes branded and generic topical retinoids and combination therapies, with procurement largely governed by pharmacy benefit management (PBM) formularies and retail channel contracting.

Which treatment classes set the competitive baseline for Altèreno?

• Topical retinoids (tretinoin formulations and comparable retinoid actives)
• Topical antibiotics and combination regimens (often favored for payer simplification where clinically appropriate)
• Combination products and fixed-dose regimens that consolidate adherence
• Generic topical tretinoin across strengths and vehicles, which competes on cost and formulary placement

Where does Altèreno sit vs generic topical tretinoin?

Altèreno’s economic case relies on differentiation in formulation/vehicle performance, tolerability profile, and patient adherence compared with older generic and legacy tretinoin vehicles. In payer dynamics, that usually translates into rebate-funded access until formulary switch pressure accelerates with expanding generic availability.

How does exclusivity and patent life translate into financial trajectory for Altèreno?

Financial trajectory for a branded dermatology product typically tracks two time windows:

1. Exclusivity + payer pull: branded spend supports channel adoption and rebate leverage.
2. Approaching patent and/or exclusivity cliff: economic headwinds as generics or AB-rated alternatives become the default payer choice.

Altèreno’s revenue path depends on whether its Orange Book-protected claims cover the marketed dosage form and whether any paragraph IV challenges target the specific listed patents. For topical acne products, formulation-vehicle and method-of-use claims often govern the timetable for generic substitution and “authorized generic” mitigation.

What drives the “pre-expiration” revenue ramp vs “post-expiration” drop?

• Ramp factors: detailing intensity, formulary inclusion, rebate rate stability, and wholesaler inventory turns
• Drop factors: AB generic entry speed, payer rebate re-contracting, and retail shift to lowest-net-cost options

When does generic entry risk become acute?

Risk rises as the product approaches the end of:

• U.S. regulatory exclusivity periods for the specific NDA (if applicable)
• Any listed Orange Book patent expiration dates
• Any exclusivity granted through pediatric or other qualifying pathways (if applicable to the specific NDA)
• Settlement timing in any patent infringement litigation affecting listed patents

What is the Orange Book status and what patents protect Altèreno?

This section requires Orange Book patent listing data for Altèreno’s NDA. The provided prompt does not include the NDA number, Orange Book listing set, or patent list with expiration dates. Without that record, a complete and accurate patent-exclusivity-and-expiration map cannot be produced.

How many competitors matter for Altèreno’s commercial performance?

In acne topical therapy, competition is concentrated in a small set of high-volume alternatives that collectively determine net pricing. For Altèreno, the relevant competitive set typically includes:

• Generic topical tretinoin in multiple strengths/vehicles available via retail and mail
• Other topical acne actives in payer-preferred formularies, especially combination regimens
• Branded acne therapies with stronger managed-care access than older retinoid SKUs

What is the pricing mechanism that determines Altèreno net sales?

Topical branded dermatology products often monetize through:

• Retail price minus rebate and chargebacks
• PBM-negotiated net price adjustments
• Medicaid preferred drug list dynamics (if applicable)
• Contract pharmacy and wholesaler ordering patterns

The revenue trajectory usually shows:

• A net sales growth phase while coverage expands
• Plateauing as rebate rates rise to defend share
• Declining net sales as formulary switches occur

What is the financial trajectory for Altèreno across product lifecycle stages?

A complete, numbers-based financial trajectory requires access to branded-product sales, company segment reporting, and channel metrics (e.g., IQVIA/IMS if used, company 10-K disclosures, or earnings supplement tables). The prompt does not provide those data, so a precise trajectory cannot be stated without generating inaccuracies.

How do analysts typically model branded dermatology revenue for lifecycle outcomes?

• Base case: continued formulary coverage, gradual growth with seasonality typical for acne therapies
• Patent-protection case: slower generic erosion, moderated net price decline
• Generic-entry case: steep volume loss after first AB entry, followed by margin compression via rebate tightening by competitors

Key financial signals to watch (what matters most)

• Net sales growth rate vs prior periods
• Gross-to-net spread (rebates and discounts)
• Prescription share by channel
• Inventory dynamics at wholesalers (risk of pull-through vs sell-in)

How does payer and formulary placement affect Altèreno revenue volatility?

Dermatology products with retinoid actives usually face payer volatility tied to:

• PBM formulary design (preferred vs non-preferred tiers)
• Step therapy and prior authorization requirements
• Switching protocols for trial-to-maintenance patterns
• Patient out-of-pocket (copay assistance or lack thereof)

What tends to happen after a competitor gains preferred status?

• Rapid net price pressure through rebate increases
• Faster conversion of new prescriptions away from the branded SKU
• Longer time to recover share for dermatology brands due to chronic use patterns

What litigation, settlements, or Paragraph IV challenges affect Altèreno’s commercial risk?

This requires the Altèreno Orange Book patent list and any associated Hatch-Waxman filings (Paragraph IV notices), plus court docket outcomes and settlement terms. The prompt provides none of those case identifiers or patent numbers, so an accurate litigation-impact section cannot be produced.

How does Altèreno’s competitive landscape compare with other topical acne brands and generics?

A rigorous comparison requires at minimum:

• Competitor product list in the same labeled indication and strength/vehicle class
• Their patent estate dates and exclusivity status
• Their net pricing and rebate levels (or proxies via payer preference) Those details are not included in the prompt, and producing a comparative analysis without them would risk inaccuracies.

What manufacturing and IP barriers could delay generic substitution of Altèreno?

Topical generics can face:

• Vehicle-formulation constraints tied to particle dispersion, stability, and release profile
• Bioequivalence study design differences (in topical, BE may rely on different bridging approaches)
• Patent barriers around formulation, method-of-use, and stability claims

A barrier analysis requires the exact Orange Book formulation patents and any known generic development constraints. Those are not provided.

What generic launch scenarios are most likely for Altèreno?

A launch-scenario framework depends on:

• The specific patents likely to be successfully designed around
• Whether generic entry would be authorized or fully generic
• Whether litigation produces an agreed “launch-on-date” or “stay” period None of these are accessible from the prompt.

What is the geographic scope of Altèreno’s market exposure?

A U.S.-only analysis could be different from a broader North America or international story. The prompt does not provide territory commercialization plans, country approvals, or distribution partners. A complete geographic view cannot be generated without core facts.

Key Takeaways

• Altèreno’s financial trajectory is driven primarily by U.S. payer access and the timing of Orange Book-protected patent and exclusivity milestones tied to the marketed topical formulation.
• Revenue typically follows a pattern of coverage build-up, rebate-funded retention, then net price and volume pressure as generic substitution becomes viable.
• A defensible market-and-patent timeline, competitive set, and litigation impact assessment require Orange Book listing data and any Hatch-Waxman case records tied to Altèreno’s NDA. Those inputs are not included in the prompt, so they cannot be stated here without risking errors.

FAQs

1. What drives gross-to-net changes for prescription topical dermatology products like Altèreno?
2. How do PBM formulary tiers and prior authorization requirements typically influence acne topical branded share?
3. What Orange Book patent types most often delay generic substitution for topical retinoid formulations?
4. How do settlement “launch date” agreements in Hatch-Waxman cases affect branded revenue after patent expiry?
5. What channel signals (sell-in vs sell-through, inventory turns) best predict revenue erosion risk for branded dermatology SKUs?

References

1. U.S. FDA Orange Book. “Drug Product Database.” (Accessed via U.S. FDA Orange Book).
2. FDA. “Hatch-Waxman Drug Patent Litigation and Paragraph IV Certification.” (U.S. FDA guidance and informational pages).