Litigation Details for GALDERMA LABORATORIES, L.P. v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2020)

GALDERMA LABORATORIES, L.P. v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2020)

Docket		Date Filed	2020-10-22
Court	District Court, D. New Jersey	Date Terminated	2021-06-14
Cause	35:271 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Douglas Arpert
Patents	8,445,543
Link to Docket	External link to docket

Details for GALDERMA LABORATORIES, L.P. v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-10-22				External link to document

Galderma Laboratories v. Zydus Pharmaceuticals Patent Litigation: Case No. 3:20-cv-14857

Last updated: August 3, 2026

Galderma Laboratories, L.P. sued Zydus Pharmaceuticals (USA) Inc. in the U.S. District Court for the District of New Jersey under the Hatch-Waxman Act after Zydus submitted an abbreviated new drug application seeking approval for a generic version of Galderma’s Aklief product, a topical trifarotene cream used to treat acne. The case was an ANDA patent dispute involving formulation and method-of-use rights. The litigation was terminated without a publicly reported merits judgment determining patent validity or infringement. [1]

What drug and ANDA were involved in Galderma v. Zydus?

The dispute concerned trifarotene cream, 0.005%, marketed by Galderma as Aklief.

Item	Detail
Brand	Aklief
Active ingredient	Trifarotene
Dosage form	Topical cream
Strength	0.005%
Indication	Topical treatment of acne vulgaris in patients aged 9 years and older
NDA holder	Galderma Laboratories, L.P.
FDA approval	Oct. 4, 2019
Litigation forum	U.S. District Court for the District of New Jersey
Civil action	No. 3:20-cv-14857
Defendant	Zydus Pharmaceuticals (USA) Inc.
Litigation type	Hatch-Waxman ANDA litigation

The FDA approved Aklief under NDA 211527. Trifarotene is a retinoid selective for the retinoic acid receptor gamma, a receptor concentrated in the skin. The product was the first FDA-approved topical treatment specifically developed around trifarotene. [2]

What patents protected Aklief in the Zydus litigation?

The case involved Galderma’s patent rights covering trifarotene pharmaceutical compositions and their use in treating acne. The asserted rights were tied to the Aklief formulation and its FDA-approved therapeutic use, rather than to a conventional small-molecule composition claim alone.

Public Hatch-Waxman records associate Aklief with patent protection covering:

Patent category	Subject matter	Generic-entry relevance
Active-ingredient and composition claims	Trifarotene-containing topical pharmaceutical compositions	Can block approval of a substantially identical cream
Formulation claims	Low-concentration topical cream compositions	Protects the commercial product’s delivery vehicle and concentration
Method-of-use claims	Use of trifarotene for acne treatment	Can support a section viii carve-out dispute or a method-of-use infringement claim
Manufacturing and formulation process rights	Preparation of the topical product	May create additional barriers but usually does not independently prevent all ANDA approval

A complete patent-by-patent analysis requires matching the complaint’s asserted patents against the Orange Book listing in effect when Zydus filed its ANDA. The public case identifier alone does not establish every patent number, asserted claim, or the precise Paragraph IV certifications made by Zydus.

What was the legal basis for the Galderma v. Zydus complaint?

Galderma’s claims arose under 35 U.S.C. § 271(e)(2), which treats submission of an ANDA containing a Paragraph IV certification as an artificial act of patent infringement.

Zydus’s ANDA submission presumably notified Galderma that Zydus believed the relevant patents were invalid, unenforceable, or would not be infringed by the proposed generic product. Galderma then had 45 days from receipt of the Paragraph IV notice to file suit. The filing triggered the statutory 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions and court action.

The principal legal questions were likely:

1. Whether the proposed Zydus cream fell within the scope of Galderma’s composition or formulation claims.
2. Whether the proposed labeling induced infringement of Galderma’s acne-treatment method claims.
3. Whether the asserted claims were invalid for anticipation, obviousness, lack of written description, or lack of enablement.
4. Whether Galderma’s patents were enforceable.
5. Whether Zydus could obtain approval through a full label or a section viii use carve-out.

Did Zydus file a Paragraph IV challenge?

The case was an ANDA patent action, which indicates that Zydus made a certification that exposed it to infringement litigation. In a typical Aklief dispute, the relevant certification would be Paragraph IV if Zydus sought approval before expiration of the listed patents.

A Paragraph IV certification does not establish that the patent is invalid or not infringed. It creates a litigation pathway and can delay FDA approval through the 30-month stay. The commercial effect depends on the asserted patent claims, the FDA’s approval timing, any pediatric exclusivity, and the terms of a settlement.

What was the procedural history of the case?

The case was filed in the District of New Jersey in 2020. The docket reflects ordinary ANDA case-management procedures, including pleadings, discovery, and judicial supervision of the patent dispute. The matter did not produce a publicly reported trial verdict or appellate decision establishing the validity or infringement of the asserted Aklief patents.

The case was later terminated. The publicly available docket does not provide a merits holding that would independently invalidate Galderma’s patents or authorize immediate Zydus entry.

Procedural issue	Assessment
Complaint	Filed by Galderma after Zydus’s ANDA certification
Patent trial	No publicly reported merits verdict
Claim construction holding	No widely reported precedential construction controlling the Aklief patent estate
Settlement	Case termination is consistent with resolution or dismissal, but publicly accessible docket materials do not establish the commercial terms
Patent validity ruling	None publicly reported in this action
Infringement ruling	None publicly reported in this action
Appeal	No reported appellate merits decision arising from this case

What was the litigation outcome?

The litigation ended without a publicly reported judgment after trial. That outcome means the case did not produce a judicial ruling that can be used to characterize the Aklief patent estate as invalid, unenforceable, or infringed.

The most important commercial consequence was likely contractual rather than precedential. Hatch-Waxman settlements commonly establish a permitted generic launch date, define whether an authorized generic may be supplied, and address patent challenges involving other products or affiliates. Unless the settlement agreement is filed publicly, the precise entry date cannot be inferred from docket termination alone.

The termination also does not mean Zydus immediately received FDA approval. FDA approval depends on the status of the ANDA, the 30-month stay, unresolved patents, regulatory deficiencies, exclusivity, and any settlement restrictions.

What is the Orange Book status of Aklief?

Aklief is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book. Orange Book listings identify patents and regulatory exclusivities submitted for the reference product. They do not determine whether a listed patent is valid or infringed.

Aklief’s Orange Book protection is commercially important because:

• a generic applicant must address listed patents through Paragraph III, Paragraph IV, or, for certain method-of-use patents, a section viii statement;
• a valid Paragraph IV suit can trigger the 30-month approval stay;
• method-of-use listings may permit a narrower generic label if the FDA accepts a carve-out;
• formulation claims are more difficult to avoid through labeling changes because they can cover the product itself.

The Orange Book should be reviewed by NDA, patent number, expiration date, and delisting status. FDA’s patent listings can change after litigation begins, and an Orange Book listing does not itself resolve a patent dispute. [3]

When does Aklief lose exclusivity?

Aklief has several distinct exclusivity dates:

Exclusivity type	Relevance
New chemical entity exclusivity	Aklief received FDA approval as a novel active ingredient. NCE exclusivity generally prevents submission of an ANDA for five years, subject to a Paragraph IV filing after four years.
Patent exclusivity	Listed patents may delay approval or commercial launch beyond regulatory exclusivity.
Pediatric exclusivity	If granted, six months may be added to applicable patent and regulatory periods.
Market exclusivity	Aklief does not have biologic reference-product exclusivity because trifarotene is a small molecule, not a biologic.

A precise generic-entry date cannot be derived from the civil-action number. It depends on the Orange Book patent term, any pediatric extension, the Zydus settlement or judgment, and the FDA’s final ANDA action.

How strong is Galderma’s Aklief patent estate?

The estate has moderate-to-strong practical protection when composition, formulation, and method-of-use claims overlap.

Strengths

• Aklief uses a differentiated active ingredient rather than an older over-the-counter retinoid.
• A topical formulation patent can create product-level infringement risk.
• Method-of-use claims may cover the FDA-approved acne indication.
• The 2019 approval date gives the product a relatively recent regulatory and commercial position.
• A Paragraph IV challenge can be expensive because topical formulation equivalence may require detailed comparison of excipients, particle characteristics, release behavior, and manufacturing controls.

Vulnerabilities

• Trifarotene belongs to an established retinoid class, creating obviousness arguments based on prior retinoid research.
• Narrow formulation claims can be vulnerable to design-around strategies.
• Method-of-use claims may be narrowed through a section viii label carve-out.
• Topical products can face claim-construction disputes over concentration, vehicle composition, penetration, and treatment instructions.
• Patent term may end before the product reaches peak commercial maturity if the estate relies primarily on early-filed composition patents.

The strongest claims are generally those that capture the proposed generic product’s physical formulation. Method claims are commercially useful but may be easier to avoid through labeling restrictions.

What generic-entry risks exist for Aklief?

The primary risks are:

1. Zydus entry after a settlement date. A settlement can create a licensed launch date earlier than the latest patent expiration.
2. Entry by another ANDA applicant. Resolution with Zydus does not eliminate challenges by other generic manufacturers.
3. Section viii approval. A generic could omit a patented indication if the FDA accepts a carve-out.
4. Formulation design-around. A competing product may use different excipients or manufacturing parameters.
5. Patent-list changes. New patents may be listed if they satisfy FDA requirements, although late-listed patents may not create the same full approval stay.
6. Regulatory exclusivity expiry. Once NCE exclusivity expires, ANDA competition can proceed if patent barriers are cleared.

Aklief’s competitive exposure is therefore tied to both patent scope and product economics. A technically different cream may avoid a narrow formulation claim while still competing for the same acne-treatment market.

How does Aklief compare with other Galderma dermatology products?

Product	Active ingredient	Product type	Main generic risk
Aklief	Trifarotene	Prescription topical cream	Formulation and method-of-use patent challenge
Soolantra	Ivermectin	Prescription topical cream	Composition, formulation, and rosacea-use patents
Epiduo	Adapalene and benzoyl peroxide	Prescription topical gel	Combination-product and formulation challenges
Oracea	Doxycycline	Modified-release oral capsule	Formulation and pharmacokinetic patent challenges
Differin	Adapalene	Topical gel or cream	Older patent estate and established generic competition

Aklief differs from older Galderma products because its commercial value depends more heavily on exclusivity surrounding a newer active ingredient and specialized topical formulation. It also competes with established topical retinoids, including adapalene and tretinoin, which limits pricing power after generic entry.

What revenue exposure did the litigation create?

The case exposed Galderma to erosion of prescription acne revenue from a generic trifarotene product. The exposure would depend on:

• the permitted Zydus launch date;
• the number of competing ANDA applicants;
• whether Zydus obtained approval for the full indication;
• payer substitution and formulary treatment;
• the size of the Aklief patient base;
• whether Galderma launched an authorized generic;
• the extent to which physicians substitute older retinoids.

A first generic entrant can obtain substantial share before additional applicants enter. A delayed or limited-label launch would reduce the immediate impact. Because Aklief is a topical product, substitution may be slower than for a chemically identical oral tablet if prescribers distinguish the vehicle, tolerability, or dosing experience.

Key Takeaways

• Galderma v. Zydus, No. 3:20-cv-14857, was a District of New Jersey Hatch-Waxman case involving a proposed generic version of Aklief, trifarotene cream 0.005%.
• The dispute centered on Galderma’s patent rights covering trifarotene compositions, topical formulation characteristics, and acne-treatment methods.
• The litigation ended without a publicly reported merits decision on validity or infringement.
• Case termination does not, by itself, establish Zydus’s FDA approval or commercial launch date.
• Aklief’s generic-entry risk depends on Orange Book patents, regulatory exclusivity, any settlement terms, and competing ANDA challenges.
• The most commercially important protection is likely the combination of product-level formulation claims and method-of-use claims.

FAQs

Can Zydus launch a generic Aklief immediately after the case ended?

No immediate launch right follows automatically from docket termination. FDA approval and any settlement restrictions must also be satisfied.

Is trifarotene eligible for biosimilar competition?

No. Trifarotene is a small-molecule drug. Competition proceeds through the ANDA generic-drug pathway, not the biosimilar pathway under the Public Health Service Act.

Can a generic avoid Aklief patents by changing the cream vehicle?

Potentially, but only if the revised product falls outside the asserted formulation claims and satisfies FDA requirements for pharmaceutical equivalence or applicable therapeutic-equivalence standards.

Does a Paragraph IV settlement prove that Galderma’s patents are valid?

No. A settlement resolves the parties’ dispute but does not create a judicial validity determination.

Could another generic manufacturer challenge Aklief after the Zydus case ended?

Yes. A settlement or dismissal involving one ANDA applicant does not prevent another applicant from filing a separate ANDA and making its own patent certifications.

References

1. U.S. District Court for the District of New Jersey. (2020). Galderma Laboratories, L.P. v. Zydus Pharmaceuticals (USA) Inc., No. 3:20-cv-14857, docket records.
2. U.S. Food and Drug Administration. (2019). Aklief approval letter and prescribing information, NDA 211527.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.