Wednesday, July 23, 2014

Tazorac, Humalog, Naprelan, Nexium IV, Saizen Drugs are Off-Patent

An expired patent cannot be renewed. After the patent on a drug expires, any pharmaceutical company can manufacture a generic version of the drug and sell it. This helps the company incur only manufacturing cost avoiding the cost of original testing, development and marketing.

A phenomenon called patent cliff arises when drugs go off-patent as a firm's revenues goes down since these products can be replicated and sold at much cheaper prices by competitors, opening opportunities for generic drug manufacturers.

All the generic products should be approved by FDA, which requires pharmaceutical companies to submit ANDA (a therapeutical equivalent to the originally approved drug). Hatch-Waxman Act is a standardized U.S. procedure for recognition of generic drugs. FDA has also launched the Generic Initiative for Value and Efficiency (GIVE) to help modernize and streamline the generic drug approval process. More generic-drug options mean more cost-savings to consumers, as they are less expensive compared to the branded drugs.

The table below (sourced from Patent Maker) illustrates some of the medical devices and pharma patents that expired[i] in June 2014 along with the respective products covered.

U.S. Patent Number
Products Covered
Medical Devices
Valve prosthesis for implantation in the body and a catheter for implanting such valve prosthesis
Edwards Sapien Transcatheter Heart Valve with the RetroFlex 3 Delivery System
Kits for high temperature reverse transcription of RNA
GeneSearch Breast Lymph Node (BLN) Assay
Biodegradable mesh and film stent
Catheters having a reusable proximal body
Guidant Multi-link Vision Coronary Stent System
Pharmaceutical composition for angiotensin II-mediated diseases
Atacand HCT & Edarbi
Sustained release comfort formulation for glaucoma therapy
Betoptic Pilo
Insulin analog formulations
Humalog (Mix, Pen, KwiKPen)
Monomeric insulin analog formulations
Humalog Mix
Stabilized microbubble compositions
Topically administrable compositions containing 3-benzoylphenylacetic acid derivatives for treatment of ophthalmic inflammatory disorders
Ilevro, Nepafenac & Nevanac
Topical application compositions
Locoid Lipocream
Sphingosomes for enhanced drug delivery
Marqibo Kit
Controlled absorption naproxen formulation for once-daily administration

Methods and compositions for the treatment of pain utilizing ropivacaine

Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole
Nexium & Vimovo
Nexium IV
Retroviral protease inhibiting compounds
Sustained release formulations of water soluble peptides

Sandostatin Lar
Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs
Stable gel formulation for topical treatment of skin conditions
hGH containing pharmaceutical compositions
Saizen, Serostim & Zorbtive
Amine polymer sequestrant and method of cholesterol depletion
Process for removing bile salts from a patient and alkylated compositions therefor
Agricultural Seeds
Rice actin gene and promoter
YieldGard Corn Borer with Roundup Ready Corn 2
DroughtGard Hybrids Corn
YieldGard Plus with Roundup Ready Corn 2
YieldGard Rootworm with Roundup Ready Corn 2
YieldGard VT Rootworm/RR2
Genuity SmartStax
Genuity VT Double PRO
Genuity VT Triple PRO and Performance Series Sweet Corn
Roundup Ready Corn 2
YieldGard VT Triple
Absorbent Products
Disposable garment with de-elasticized elastic members and method for making same
Depend Real Fit for Men
Depend Adjustable Underwear
Depend Silhouette for Women
Depend Underwear

Patent Marker is a database of products and patents, in which the patents that apply to each product are identified. Any registered user is free to add a product for marking. Patent Marker is an online tool that makes it easy for companies/patentees to mark their products and serve notice to the public of their ownership of inventions.
The database includes powerful search functionality that can be used to identify products and their related-patents, patent expiration date, number of litigations the patent is involved, etc. The database interfaces with MaxVal’s Litigation Databank and Assignment Database to retrieve litigation and current assignee information, respectively.  

[i] Expected Expiration Date

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