Harrow and Nicox Sue Micro Labs Over a Generic Zerviate Cetirizine ANDA.

The case

The case is Harrow, Inc., Harrow Eye, LLC, Harrow IP, LLC and Nicox Ophthalmics, Inc. v. Micro Labs Limited and Micro Labs USA, Inc., No. 2:26-cv-13774 (D.N.J.), a 30-page complaint filed October 22, 2026, Document 1. The plaintiffs are Harrow, Inc.; Harrow Eye, LLC, the holder of New Drug Application No. 208694 for ZERVIATE; Harrow IP, LLC; and Nicox Ophthalmics, Inc., which the complaint identifies as the assignee and owner of the asserted patents. The complaint describes the three Harrow entities as exclusive licensees of the patents. The defendants are Micro Labs Limited and Micro Labs USA, Inc. The complaint arises under 35 U.S.C. 271(e)(2).

The drug and the patents

ZERVIATE is cetirizine ophthalmic solution 0.24%, a histamine-1 receptor antagonist indicated for the treatment of ocular itching associated with allergic conjunctivitis; its label states that safety and effectiveness have been established in pediatric patients two years of age and older. FDA approved NDA No. 208694 on May 30, 2017. The complaint asserts five patents, each titled Ophthalmic Formulations of Cetirizine and Methods of Use: U.S. Patent 8,829,005 (issued September 9, 2014); 9,254,286 (February 9, 2016); 9,750,684 (September 5, 2017); 9,993,471 (June 12, 2018); and 11,918,573 (March 5, 2024). It states that the '005, '286, '684, and '471 patents are listed in the FDA Orange Book for ZERVIATE.

Claim 1 of the '005 patent, as recited in the complaint, covers a method for alleviating a sign or symptom of allergic conjunctivitis by topically administering to an eye an ophthalmic formulation with a single active ingredient consisting of 0.24% (w/v) cetirizine twice daily, where the formulation does not contain a cyclodextrin, comprises a listed vehicle including polyethylene glycol 400, dibasic sodium phosphate, hypromellose, polysorbate 80, glycerin, benzalkonium chloride, and purified water, and has a pH of 6.8 to 7.2.

Claim 1 of the '286 patent, as recited, covers a topical ophthalmic formulation consisting essentially of 0.24% cetirizine (w/v) with a listed vehicle including edetate disodium, the same core inactive ingredients, pH 6.8 to 7.2, and no cyclodextrin or other solubilizing compound. Claim 1 of the '684 patent covers a topical ophthalmic formulation comprising 0.1% to 0.25% (w/v) cetirizine hydrochloride or dihydrochloride as the only active agent in a vehicle with polyethylene glycol 400, dibasic sodium phosphate, hypromellose, polysorbate 80, 1.2% to 1.8% glycerin, edetate disodium, benzalkonium chloride, and purified water, at pH 7, without a cyclodextrin or other solubilizing compound. Claim 1 of the '471 patent covers a method of treating signs and symptoms of allergic conjunctivitis by topically administering a formulation in that same composition range. Claim 1 of the '573 patent covers a topical ophthalmic formulation comprising cetirizine hydrochloride or dihydrochloride at 0.05% to 0.5% (w/v) calculated as cetirizine free base as the only active agent, in a vehicle with a demulcent and/or viscosity-enhancing polymer, a preservative, a polysorbate surfactant at 0.02 to 0.1% (w/v), a polyethylene glycol carrier, and water, at about pH 5.5 to 7.5, viscosity 1 to 50 centipoise, and osmolality about 225 to 400 mOsm/kg, without a cyclodextrin.

The ANDA and the notice letter

The complaint alleges that Micro Labs submitted ANDA No. 221761 seeking approval to manufacture, use, sell, offer for sale, and/or import a purported generic version of ZERVIATE (cetirizine ophthalmic solution) 0.24% before the Asserted Patents expire, and that, on information and belief, FDA has not approved that ANDA. According to the complaint, Micro Labs sent a Notice Letter dated September 8, 2026, which plaintiffs received on September 9, 2026. The letter represented that Micro Labs had submitted the ANDA with a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (Paragraph IV) as to the '005, '286, '684, and '471 patents. The complaint states that this action was brought within forty-five days of receipt of the Notice Letter and that plaintiffs are entitled to a thirty-month stay of FDA approval under 21 U.S.C. 355(j)(5)(B)(iii) until March 9, 2029.

The counts

Counts I through IV assert infringement of the '005, '286, '684, and '471 patents, respectively, under 35 U.S.C. 271(e)(2)(A) based on submission of the ANDA with a Paragraph IV certification, and allege that commercial manufacture, use, sale, offer for sale, or importation of the Micro Labs ANDA Product before patent expiry would infringe at least claim 1 of each patent, including by inducement and contribution. Count V asserts the '573 patent under 35 U.S.C. 271(e)(2)(A) and seeks a declaration that future commercial activity before that patent expires would infringe under 35 U.S.C. 271(a), (b), and (c). Counts I through IV allege that Micro Labs' conduct in certifying invalidity and/or noninfringement renders the case exceptional under 35 U.S.C. 285; Count V bases the same allegation on Micro Labs' continued pursuit of approval with knowledge of the '573 patent.

The relief sought

The prayer asks for a judgment that submission of ANDA No. 221761 was an act of infringement of one or more claims of the Asserted Patents; a judgment that making, using, offering to sell, selling, marketing, distributing, or importing the ANDA product before patent expiry will infringe under 35 U.S.C. 271(a), (b), and/or (c); a declaration under 28 U.S.C. 2201 and 2202 as to future infringement of the '573 patent; an order under 35 U.S.C. 271(e)(4)(A) that the effective date of any FDA approval not be earlier than the expiration of the last to expire of the Asserted Patents, including extensions and exclusivity; a permanent injunction under 35 U.S.C. 271(e)(4)(B) and/or 283; damages or other relief under 35 U.S.C. 271(e)(4)(C) if commercial activity occurs before expiry; a declaration that the case is exceptional with attorneys' fees under 35 U.S.C. 285; costs and expenses; and other relief.

What to watch next

Watch for Micro Labs' answer or Rule 12 motion, a scheduling order, and the March 9, 2029 date the complaint gives for the end of the thirty-month stay. The case can end at any time, including by settlement or voluntary dismissal.