Bausch Health v. Padagis: Arazlo® ANDA Patent Dispute Settled After 683 Days
Bausch Health Ireland, Ltd. and affiliates sued Padagis entities in the District of New Jersey asserting US Patent No. 11,311,482 covering Arazlo® (tazarotene) lotion against a generic ANDA filing. The parties reached a confidential settlement and license agreement, with all claims dismissed without prejudice after nearly two years of litigation.
Bausch Health’s Arazlo® ANDA Battle Ends in Confidential License
Filed on June 24, 2022, in the District of New Jersey, this consolidated action saw Bausch Health Ireland, Ltd., Bausch Health Americas, Inc., and Bausch Health US, LLC (collectively, Bausch) assert US Patent No. 11,311,482 — covering the tazarotene lotion formulation marketed as Arazlo® — against Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC. The suit was triggered by Padagis’s Paragraph IV ANDA certification, a statutory mechanism by which a generic applicant challenges a branded drug’s listed patents as invalid or not infringed.
After 683 days of litigation, the parties executed a Confidential Settlement and License Agreement, leading to dismissal of all complaints, counterclaims, and affirmative defenses without prejudice and without costs. Critically, the stipulation explicitly acknowledges that Padagis retains its right to maintain its Paragraph IV certification to US Patent Nos. 11,311,482 and 11,679,116, and confirms that no 30-month stay is in effect with respect to Padagis’s ANDA approval under 21 U.S.C. § 355(j)(5)(B)(iii).
The retention of the Paragraph IV certification language — combined with the confidential licensing arrangement — suggests the parties reached a commercially negotiated resolution, possibly including an authorized generic agreement or defined market entry date for Padagis, consistent with common Hatch-Waxman settlement structures. The terms of the license remain undisclosed, and the public record does not reveal any royalty rates, entry dates, or exclusivity arrangements. The court retained jurisdiction to enforce the stipulation, signalling both parties treated the settlement as binding and complex.
Filing to Dismissed without Prejudice in 683 days
683 days — above the median for ANDA patent cases in NJ District Court
Dismissed without prejudice: what the settlement structure means for both parties
Dismissed without prejudice under confidential license
A dismissal without prejudice means Bausch Health technically retains the right to refile infringement claims — the litigation is not resolved on the merits. In Hatch-Waxman settlements, this structure is standard: it accommodates a confidential license that governs the parties’ future conduct without a court adjudicating validity or infringement. The court retaining jurisdiction to enforce the agreement adds an enforcement backstop beyond the dismissal itself.
No merits adjudicationDismissed without prejudice — refiling remains possible in theory
The stipulation expressly states dismissal is ‘without prejudice.’ This means Bausch Health is not legally barred from reasserting infringement claims — for example, if Padagis launches before any agreed entry date or outside the licence terms. In practice, however, a confidential settlement and license agreement typically governs the parties’ commercial relationship going forward, making refiling contingent on a licence breach rather than a strategic choice.
Without prejudice confirmedPadagis retains its Paragraph IV certification rights
The stipulation explicitly acknowledges Padagis’s right to maintain its Paragraph IV certification to US Patent Nos. 11,311,482 and 11,679,116 under 21 C.F.R. § 314.94(a)(12)(v). This is commercially significant: Padagis preserves its regulatory position without conceding infringement or invalidity. The confirmation that no 30-month stay remains in effect means FDA approval of the Padagis ANDA is not legally blocked, though entry timing will be governed by the confidential licence.
No 30-month stay in effectConfidential licence likely defines Padagis’s market entry window
Hatch-Waxman settlements resolving Paragraph IV disputes typically include defined market entry dates, royalty arrangements, or authorised generic provisions. The combination of a retained Paragraph IV certification, no active 30-month stay, and a confidential licence agreement is consistent with Bausch Health granting Padagis a future entry date — potentially before patent expiry. Competitors watching the Arazlo® generic landscape should monitor ANDA approval status and any authorised generic announcements closely.
Authorised entry date likely agreedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch Health Ireland, Ltd. | Company | Specialty pharmaceutical company — holder of US11311482 covering Arazlo® tazarotene lotionSearch in Eureka ↗ |
| Co-Plaintiff | Bausch Health Americas, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bausch Health Us, LLC | Company | Search in Eureka ↗ |
| Defendant | Padagis Israel Pharmaceuticals, Ltd. | Company | Generic pharmaceutical manufacturer pursuing ANDA approval for tazarotene lotionSearch in Eureka ↗ |
| Co-Defendant | Padagis, LLC | Company | Search in Eureka ↗ |
| Co-Defendant | Padagis US, LLC | Company | Search in Eureka ↗ |
| Plaintiff counsel | Harvey Bartle , IV | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | J. BRUGH LOWER | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | William P. Deni , Jr. | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | MORGAN LEWIS & BOCKIUS LLP | Law Firm | Representing Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Defendant counsel | Cali Roth Spota | Attorney | Counsel for Padagis Israel Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Defendant counsel | Karen A. Confoy | Attorney | Counsel for Padagis Israel Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Defendant law firm | Fox Rothschild, LLP | Law Firm | Representing Padagis Israel Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Defendant law firm | FOX ROTHSCHILD LLP PC | Law Firm | Representing Padagis Israel Pharmaceuticals, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated dismissal language is carefully constructed: all claims are dismissed without prejudice, yet the court retains jurisdiction to enforce both the stipulation and the underlying settlement agreement. The explicit acknowledgment of Padagis’s Paragraph IV certification rights and the confirmation that no 30-month stay is operative are legally consequential provisions — they clarify the regulatory and commercial position of both parties post-dismissal without requiring a merits ruling on infringement or validity of US11311482.
US11311482 — Tazarotene Lotion Formulation (Arazlo®)
US Patent No. 11,311,482 (application number US16/179,561) covers the tazarotene lotion formulation commercialised by Bausch Health as Arazlo® — a topical retinoid indicated for acne vulgaris. Tazarotene is a well-established active ingredient, but formulation patents protecting specific delivery vehicles, excipient compositions, and dosing concentrations are a principal mechanism through which branded pharmaceutical companies extend market exclusivity beyond the active compound’s primary patent term.
The commercial stakes around Arazlo® formulation patents are considerable: Arazlo® represented a differentiated topical acne product in a competitive dermatology market. The settlement’s reference to a second patent — US11679116 — alongside US11311482 suggests Bausch Health constructed a layered formulation patent portfolio around this product. For generic manufacturers, this layered approach demands careful FTO analysis across the full patent family, not merely the asserted claim, before committing to ANDA development and launch expenditure.
Should you run an FTO analysis against US11311482 and the Arazlo® patent estate?
Any pharmaceutical company developing a generic or improved tazarotene topical formulation — particularly lotion vehicles — should treat this case as a trigger for a formal FTO assessment. The settlement confirms US11311482 and US11679116 both remain live and unchallenged on the merits. Padagis’s retained Paragraph IV certification signals these patents are commercially relevant barriers, not yet adjudicated as invalid. R&D and regulatory teams working on ANDA filings or 505(b)(2) pathways for tazarotene products should map their formulation against both patents before proceeding.
PatSnap Eureka’s FTO Search Agent allows you to run a rapid claim-mapping analysis against US11311482 and related family members, identify prosecution history estoppel risks, and surface any continuation or divisional applications that could extend the exclusivity window. For Hatch-Waxman contexts, Eureka can also flag other pending ANDAs and related paragraph IV certifications in the same active ingredient class — giving your team a complete competitive and legal risk picture before making ANDA investment decisions.
Run a freedom-to-operate analysis on US11311482B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ANDA Cases in NJ District Court: Topical Pharma
Explore comparable Paragraph IV ANDA patent disputes involving topical pharmaceutical formulations litigated in the District of New Jersey.
What this case signals for the tazarotene and Hatch-Waxman IP landscape
This settlement follows a well-worn ANDA litigation pattern — but the Paragraph IV retention language makes it more commercially revealing than most.
No 30-month stay means Padagis ANDA approval is not legally blocked
The parties’ stipulation confirms the 30-month stay triggered by Bausch’s original infringement filing is no longer operative. This matters: FDA can approve Padagis’s tazarotene ANDA without a court-ordered barrier. Whether Padagis actually launches — and when — will be determined by the confidential licence terms, not by regulatory gatekeeping.
Retained Para IV cert signals Bausch accepted commercial compromise
Allowing Padagis to maintain its Paragraph IV certification without concession of validity or infringement is a hallmark of a negotiated entry licence. Bausch Health’s decision to settle — rather than press for a validity ruling — suggests internal assessment of litigation risk against US11311482, or a preference for controlled generic competition over uncertain trial outcomes.
Bausch v Padagis — key questions answered
The case was dismissed without prejudice on May 7, 2024, following a confidential settlement and license agreement between Bausch Health and Padagis. No merits ruling on infringement or validity of US11311482 was issued. The stipulation confirmed no 30-month stay remains in effect and that Padagis retains its Paragraph IV certification rights.
Bausch Health asserted US Patent No. 11,311,482 (application US16/179,561), which covers the tazarotene lotion formulation marketed as Arazlo®. The settlement stipulation also references US11679116 in connection with Padagis’s retained Paragraph IV certification rights, suggesting a broader formulation patent estate was commercially relevant to the resolution.
The stipulation explicitly preserves Padagis’s right to maintain its Paragraph IV certification to US11311482 and US11679116 under 21 C.F.R. § 314.94(a)(12)(v). This means Padagis does not concede validity or infringement. Combined with the confirmation that no 30-month stay is operative, Padagis’s ANDA is not legally blocked from FDA approval — though the confidential licence likely governs the actual commercial entry date.
No. The settlement stipulation expressly acknowledges that there is no 30-month stay in effect with respect to the approval of the Padagis ANDA under 21 U.S.C. § 355(j)(5)(B)(iii). This means FDA approval is not legally barred by the prior litigation filing. The timing of any actual generic market entry will be governed by the terms of the confidential settlement and license agreement.
Bausch Health was represented by Gibbons PC and Morgan Lewis & Bockius LLP, with attorneys Harvey Bartle IV, J. Brugh Lower, and William P. Deni Jr. on record. Padagis was represented by Fox Rothschild LLP, with attorneys Karen A. Confoy and Cali Roth Spota listed as counsel of record.
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