For the full list of excipients, see section 6.1. Patent Number: See Plans and Pricing Ozurdex is a drug marketed by Allergan and is included in one NDA. The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. Aug 25, 2022 11:35am. OZURDEX (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used: To treat adults with diabetic macular edema To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) A 51-year-old woman reported a 3-week history of left eye photopsia. Ocular implant made by a double extrusion process Patients with a patent peripheral iridotomy who received Ozurdex intravitreal implants are at risk for migration of the implant into the anterior chamber. Ozurdex: - Store at room temperature (between 59 to 86 degrees F) ReadySharp Dexamethasone: - Discard product if it contains particulate matter, is cloudy, or discolored - Protect from freezing - Protect from light - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F - Store in carton until time of use Simplist Dexamethasone: 11 Description. Patent Number: See Plans and Pricing SRF Limited -Walk-In Interviews for Jr. Engineer/ Sr. Executive Production / Mechanical/ Instrumentation On 11th Nov 2022, Lupin Limited-Walk-In Interview for Production/ Quality Control On 12th Nov 2022, Annora Pharma -Walk-In Interview for Production/ QC/ QA/ ARD/ Engineering/ Warehouse On 12th Nov 2022. This is an expansion from the FDA approval in June of Ozurdex for treating DME in pseudophakic and phakic adult patients. Section 3.0 - Patent Information Application Number Trade Name Patent Expiration 098-431 TYLAN 20, TYLAN 40 1111111 12/08/2016 141-025 Cattlyst 9149456 06/15/2029 141-026 Program Suspension 5776982 07/07/2015 141-033 Antisedan 4933359 05/14/2007 141-033 Antisedan 4689339 08/06/2010 141-035 Program Flavor Tabs 5776982 07/07/2015 Contact Us Today Drug Patents Expiring in 2023 Entresto Sacubitril; Valsartan Sales: $1.7 Billion (2018) More information about this Drug Dosage: Tablet; Oral Company: Novartis Pharmaceuticals Corporation Ingredients: Sacubitril; Valsartan Vimpat (lacosamide) manufactured by UCB is an anticonvulsant and anti-epileptic drug. Macular edema due to BRVO or CRVO Re-inj 0.7 mg if there is reoccurrence of macular edema or vascular leakage in the macula. Pharmacist Instructions for a Patient with an Eligible Third-Party Payer: When you redeem this card, you certify that you have not submitted and will not submit a claim for reimbursement under any federal, . OZURDEX Warnings/Precautions: Monitor for intravitreal injection-related effects (eg, endophthalmitis, eye inflammation, increased intraocular pressure, retinal detachments) following the injection. Name of the medicinal product. 1.3 Diabetic Macular Edema An apparatus and methods for delivering ocular implants or microimplants. Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Los Angeles Ozurdex Attorneys | Decades of Experience 866-884-1717 Ozurdex We've won over $550,000,000 for our clients. Chromatography (TLC / LC / HPLC / UPLC / GC), Complete Pharmacopoeial / Compendial Testing, Bioanalytical & Biomarker Testing Services, Bioequivalence / Clinical / Pre-Clinical Testing, Calculation and Modeling of Pharmacokinetic Parameters, Protein Isolation, Identification and Characterization, Electrical Conductivity / High Voltage Leak Detection (HVLD), Controlled / Immediate / Modified Release, Health / Dietary Supplement (Nutraceutical), Low Temperature / Cryogenic Condition (-78 C), Pharmacokinetics / Pharmacodynamics / Pharmacometrics, Clinical Research Translation / Validation, Pharmacovigilance / Product Lifecycle Management, High Potent / Biologic / Controlled Substance, Customization (Anodizing, Siliconization, Plastic Coating), Media / Public Relations / Communications, Methacrylic Acid - Ethyl Acrylate Copolymer, Methacrylic Acid Methyl Methacrylate Copolymer, Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer, Betadex Sulfobutyl Ether Sodium Excipient, Sodium Phosphate Dibasic 7-hydrate Excipient, Sodium Phosphate Dibasic Anhydrous Excipient, Sodium Phosphate Monobasic Anhydrous Excipient, Sodium Phosphate Monobasic Dihydrate Excipient, Sodium Phosphate Monobasic Monohydrate Excipient, Hydroxypropyl methylcellulose acetate succinate, Cross Linked Sodium Carboxymethylcellulose, Hepatology (Liver, Pancreatic, Gall Bladder). The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release. Key points about OZURDEX The swelling in your retina can be caused by several factors OZURDEX is a corticosteroid and works to help reduce the inflammation in your retina. There are seven patents protecting this drug. Should You Swap Your Beer for a White Claw? At baseline, 243 of the 324 OZURDEX subjects were phakic; 230 of 328 sham-controlled subjects were phakic. It is used to treat adults with impaired vision due to macular oedema associated with: blockage of the veins carrying blood from the back of the eye; This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ozurdex (dexamethasone 700g) sustained release intravitreal implant is listed on the Pharmaceutical Benefits Scheme (PBS) for patients with non-infectious posterior segment uveitis. Drugs may be covered by multiple patents or regulatory protections. We and our partners use cookies to Store and/or access information on a device. The Following Codes May Apply to OZURDEX Product Codes For appropriate reimbursement, follow this important coding guidance: 1 The PBS indication for Ozurdex, a targeted long-acting intravitreal steroid treatment, 2 is non-infectious uveitis affecting the posterior segment of the eye, in patients with a documented best corrected visual . Format is RX, OTC, DISCN. 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It is indicated for the treatment of adult patients with macula oedema following retinal vein occlusion (either branch or central)[ 23 ], and inflammation of the posterior segment of the eye presenting as non-infectious uveitis[ 24 ]. Methods: A systematic review using MEDLINE, EMBASE, and PubMed database searches was conducted with the . 8506987. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Patent Expiration: See Plans and Pricing Drug Patents Expiring in 2025 Xalkori Crizotinib Sales: $524 Million (2018) More information about this Drug Dosage: Capsule; Oral Company: Pfizer Ingredients: Crizotinib Treatment: Non-Small Cell Lung Carcinoma Omegaven Also disclosed herein are methods of treating, ameliorating, or reducing ophthalmic conditions or diseases by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein. one hundred and twenty-four patent family members, AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE, Corticosteroids, moderately potent (group II), CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS, Corticosteroids, moderately potent, other combinations, Corticosteroids, combinations for treatment of acne, Systemic hormonal preparations, excluding sex hormones and insulins, DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE, Corticosteroids/antiinfectives/mydriatics in combination, ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION, OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS, + Get email alerts for changes to this table, LOE / Major Patent Expirations 2022 - 2023, ClinicalTrialExchange - Connecting volunteers and trials, World Intellectual Property Organization (WIPO), METHODS AND APPARATUS FOR DELIVERY OF OCULAR IMPLANTS, PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. Following a second injection of OZURDEX in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year. Continue with Recommended Cookies, October 20, 2020 If you want to get the drug patents expiration list from 2021 to 2025, Download the PDF by filling out the form below. Patented Use: TREATMENT OF MACULAR EDEMA, Ocular implant made by a double extrusion process Patent use: TREATMENT OF DIABETIC MACULAR EDEMA, Patent use: TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL RETINAL VEIN OCCLUSION (CRVO), Patent use: TREATMENT OF NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE, Patent use: DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THE APPROVED LABELING OF OZURDEX. The (corticosteroid) drug-filled implant is approved for treating adults with macular edema (swelling) caused by retinal vein occlusion and diabetic macular edema, caused by diabetic retinopathy. The most frequently reported adverse events were increased IOP (25 % with OZURDEX and 7% with the sham) and . Identify potential brand extensions & 505(b)(2) entrants. A generic version of OZURDEX was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983. Intravitreal Injection Procedure - Ozurdex. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Patent Use Code. Migration of ozurdex implant into the anterior chamber Retin Cases Brief Rep. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. The PLACID study randomized patients with diffuse DMO to 0.7 mg Ozurdex implant followed by laser photocoagulation at 1 month (n = 126) or to sham injection followed by laser photocoagulation at 1 month (n = 127). Ozurdex consists of a biodegradable and bioerodible . Patent expiration dates: January 9, 2023 Patent use: TREATMENT OF MACULAR EDEMA Drug product January 9, 2023 Patent use: TREATMENT OF UVEITIS Drug product Ozurdex (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). URL Supplier Web Content. Please see additional Important Safety Information on the following pages. On slit-lamp examination OZURDEX is used to treat adult patients with: Vision loss due to diabetic macular oedema (DME), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment. Patent Expiration: See Plans and Pricing Cataracts And Cataract Surgery. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX required surgical procedures for management of elevated IOP.. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ozurdex. The apparatus is ergonomically designed for ease of use, and a simple manual depression of an actuator produces proportional movement of a linkage causing the implant or microimplant to be ejected through a cannula disposed at the desired location in the eye. Dosage/Direction for Use. Region and methods for ozurdex patent expiration DME in pseudophakic and phakic adult patients Angeles Ozurdex Attorneys | Decades Experience... Were phakic the FDA approval in June of Ozurdex was approved as dexamethasone by XSPIRE PHARMA on 28th. 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