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 Title	Owner/Assignee	Products Covered
Medical Devices
6582462 Valve prosthesis for implantation in the body and a catheter for implanting such valve prosthesis	Edwards Life Sciences	Edwards Sapien Transcatheter Heart Valve with the RetroFlex 3 Delivery System
5641864 Kits for high temperature reverse transcription of RNA	Roche Molecular Systems	GeneSearch Breast Lymph Node (BLN) Assay
5629077 Biodegradable mesh and film stent & 6248092 Catheters having a reusable proximal body	Advanced Cardiovascular Systems	Guidant Multi-link Vision Coronary Stent System
Drug
5958961 Pharmaceutical composition for angiotensin II-mediated diseases	Takeda	Atacand HCT & Edarbi
5635172 Sustained release comfort formulation for glaucoma therapy	Alcon Research	Betoptic Pilo
5637611 Medicaments	Deutsche Bank	Frova
5474978 Insulin analog formulations	Eli Lilly and Company	Humalog (Mix, Pen, KwiKPen)
5461031 Monomeric insulin analog formulations	Eli Lilly and Company	Humalog Mix
5639443 Stabilized microbubble compositions	Targeson	Imagent
5475034 Topically administrable compositions containing 3-benzoylphenylacetic acid derivatives for treatment of ophthalmic inflammatory disorders	Alcon Research	Ilevro, Nepafenac & Nevanac
5635497 Topical application compositions	Astellas Pharma	Locoid Lipocream
5543152, 5741516 & 5814335 Sphingosomes for enhanced drug delivery	Silicon Valley Bank	Marqibo Kit
5637320 Controlled absorption naproxen formulation for once-daily administration	N/A	Naprelan
5834489 Methods and compositions for the treatment of pain utilizing ropivacaine	Frensenius Kabi	Naropin
5877192 Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole	Astrazeneca	Nexium
6875872 Compounds	N/A	Nexium & Vimovo
6143771 Compounds	Astrazeneca	Nexium IV
5635523 Retroviral protease inhibiting compounds	Abbvie	Norvir
5639480 Sustained release formulations of water soluble peptides	Novartis	Sandostatin Lar
5639738 Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs	Jagotec AG	Solaraze
5914334 & 6258830 Stable gel formulation for topical treatment of skin conditions	N/A	Tazorac
5898030 hGH containing pharmaceutical compositions	Merck Serono SA	Saizen, Serostim & Zorbtive
5607669 Amine polymer sequestrant and method of cholesterol depletion	Genzyme	Welchol
5917007, 5919832, 6066678, 6433026, 6784254 & 7101960 Process for removing bile salts from a patient and alkylated compositions therefor	Genzyme	Welchol
Agricultural Seeds
5641876 Rice actin gene and promoter	N/A	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
5622581 Disposable garment with de-elasticized elastic members and method for making same	N/A	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.  

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[i] Expected Expiration Date