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Serving leading biopharmaceutical companies globally:

Colorcon
Queensland Health
Healthtrust
Boehringer Ingelheim
Harvard Business School
QuintilesIMS
Express Scripts
Federal Trade Commission
Moodys
Cerilliant

Generated: January 20, 2018

DrugPatentWatch Database Preview

DEXAMETHASONE - Generic Drug Details

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What are the generic sources for dexamethasone and what is the scope of dexamethasone patent protection?

Dexamethasone
is the generic ingredient in thirty-one branded drugs marketed by Allergan Herbert, Merck, West-ward Pharms Int, Alpharma Us Pharms, Lyne, Sti Pharma Llc, Vintage Pharms, Wockhardt Eu Operatn, Organon Usa Inc, Allergan, Watson Labs, Novartis Pharms Corp, ECR, Idt Australia Ltd, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Solvay, Aspen Global Inc, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz Inc, Alcon Pharms Ltd, Novartis, and Perrigo Co Tennessee, and is included in one hundred and twenty-four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has one hundred and thirty-three patent family members in twenty-six countries.

There are thirty-nine drug master file entries for dexamethasone. Thirty-four suppliers are listed for this compound.
Summary for DEXAMETHASONE
Pharmacology for DEXAMETHASONE
Medical Subject Heading (MeSH) Categories for DEXAMETHASONE

US Patents and Regulatory Information for DEXAMETHASONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck DECADRON dexamethasone sodium phosphate CREAM;TOPICAL 011983-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Labs Ltd DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 040803-001 Aug 29, 2008 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 084916-001 Approved Prior to Jan 1, 1982 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Organon Usa Inc HEXADROL dexamethasone sodium phosphate INJECTABLE;INJECTION 014694-004 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int DEXAMETHASONE dexamethasone SOLUTION;ORAL 088248-001 Sep 1, 1983 RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int DEXAMETHASONE dexamethasone TABLET;ORAL 088316-001 Sep 15, 1983 BP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck DECADRON dexamethasone TABLET;ORAL 011664-005 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm DEXAMETHASONE dexamethasone TABLET;ORAL 088160-001 Apr 28, 1983 BP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 083702-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818-001 Feb 13, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for DEXAMETHASONE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,625,582 Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor ➤ Subscribe
8,048,445 Ocular implant made by a double extrusion process ➤ Subscribe
7,090,681 Methods and apparatus for delivery of ocular implants ➤ Subscribe
8,828,446 Method for reducing transplant rejection in the eye and intraocular implants for use therefor ➤ Subscribe
8,242,099 Implants and methods for treating inflammation-mediated conditions of the eye ➤ Subscribe
7,147,644 Apparatus for delivery of ocular implants ➤ Subscribe
7,753,916 Methods and apparatus for delivery of ocular implants ➤ Subscribe
7,468,065 Apparatus for delivery of ocular implants ➤ Subscribe
8,318,070 Ocular implant made by a double extrusion process ➤ Subscribe
7,846,468 Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for DEXAMETHASONE

Supplementary Protection Certificates for DEXAMETHASONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000081 Germany ➤ Subscribe PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
C0012 France ➤ Subscribe 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
C/GB12/047 United Kingdom ➤ Subscribe PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
C/GB12/058 United Kingdom ➤ Subscribe 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
00552 Netherlands ➤ Subscribe PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Colorcon
Mallinckrodt
Novartis
Fish and Richardson
Covington
Farmers Insurance
Julphar

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