DEXTENZA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Dextenza, and when can generic versions of Dextenza launch?
Dextenza is a drug marketed by Ocular Therapeutix and is included in one NDA. There are four patents protecting this drug.
This drug has twenty-six patent family members in six countries.
The generic ingredient in DEXTENZA is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dextenza
A generic version of DEXTENZA was approved as dexamethasone by HIKMA on September 15th, 1983.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DEXTENZA?
- What are the global sales for DEXTENZA?
- What is Average Wholesale Price for DEXTENZA?
Summary for DEXTENZA
| International Patents: | 26 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 45 |
| Patent Applications: | 4,423 |
| Drug Prices: | Drug price information for DEXTENZA |
| What excipients (inactive ingredients) are in DEXTENZA? | DEXTENZA excipients list |
| DailyMed Link: | DEXTENZA at DailyMed |
Recent Clinical Trials for DEXTENZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wyse Eyecare | Phase 4 |
| Duke University | Early Phase 1 |
| Navy Medical Center San Diego | Phase 4 |
Pharmacology for DEXTENZA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for DEXTENZA
DEXTENZA is protected by five US patents and one FDA Regulatory Exclusivity.
Patents protecting DEXTENZA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY
Drug delivery through hydrogel plugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Drug delivery through hydrogel plugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DEXTENZA IS APPROVED FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY
Composite hydrogel drug delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting DEXTENZA
TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DEXTENZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DEXTENZA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AbbVie Deutschland GmbH & Co. KG | Ozurdex | dexamethasone | EMEA/H/C/001140 Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. |
Authorised | no | no | no | 2010-07-26 | |
| THERAVIA | Neofordex | dexamethasone | EMEA/H/C/004071 Treatment of multiple myeloma. |
Authorised | no | no | no | 2016-03-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DEXTENZA
See the table below for patents covering DEXTENZA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2760704 | BIOMATERIAUX POUR LA FERMETURE DE VOIE ET DE PONCTION (BIOMATERIALS FOR TRACK AND PUNCTURE CLOSURE) | ⤷ Sign Up |
| Japan | 6110416 | ⤷ Sign Up | |
| Japan | 5890182 | ⤷ Sign Up | |
| Japan | 5684239 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEXTENZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| 1581193 | SPC/GB12/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| 1429780 | 13C0012 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
