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OPHTHAINE

NDA

PROPARACAINE HYDROCHLORIDE | N008883 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner LLP FDA-2020-P-1260 · 7 docket documents Foley & Lardner LLP submitted this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting that the FDA designate ALCAINE (Proparacaine Hydrochloride) Ophthalmic Solution 0.5%, ANDA A080027 held by Alcon Laboratories Inc., as an additional reference standard to enable development of a	Other	2020-04-07	Withdrawn	Foley & Lardner LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

14 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Three Different Anesthetic Approaches for Intravitreal Injections NCT02263690	Phase 4	Completed	Retina Clinic, Sao Paulo, Brazil	92	2014-06 → 2014-09
Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections NCT01027611	Phase 3	Completed	Illinois Retina Associates	120	2009-10 → 2009-12
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections NCT02951351	N/A	Completed	Mayo Clinic	36	2016-10-12 → 2018-02
Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts NCT02895074	N/A	Completed	Sun Yat-sen University	40	2014-08 → 2015-06
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection NCT00769392	N/A	Completed	Lahey Clinic	28	2008-09 → 2009-08-12
Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens NCT02609997	N/A	Completed	Sun Yat-sen University	65	2012-09 → 2012-12
Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification NCT02925832	N/A	Completed	Government Medical College, Haldwani	100	2016-10 → 2016-12
Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival NCT01640171	N/A	Completed	Retina Vitreous Associates of Florida	57	2012-07 → 2013-10
Proparacaine vs Placebo for Corneal Injuries NCT00620997	Phase 1	Completed	London Health Sciences Centre	43	2005-10 → 2006-09
Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?NCT04229771	Phase 4	Terminated	Corewell Health East	2	2020-06-30 → 2020-11-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED LTDPROPARACAINE HYDROCHLORIDE

DMF 26981976

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.