Brand drug manufacturers might welcome Amazon, at least initially, as an additional channel to reach consumers.
Not exact matches
The world's largest
drug manufacturer is facing steep competition from a slew of smaller generic players, and the recent loss of patent protection on its major
branded drug, Copaxone, is threatening Teva's profit margins.
Some
manufacturers have recently boosted discounts as insurers and benefits managers have excluded more - expensive
brands from lists of covered
drugs.
For a generic
drug manufacturer to get the U.S. Food and Drug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand vers
drug manufacturer to get the U.S. Food and
Drug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand vers
Drug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name -
brand version.
Private Label
Manufacturers Association — Labeling and Packaging Members represent small to large manufacturers of food and non-food products sold under store brands and private label brands in supermarkets, drug stores, mass merchandisers or special
Manufacturers Association — Labeling and Packaging Members represent small to large
manufacturers of food and non-food products sold under store brands and private label brands in supermarkets, drug stores, mass merchandisers or special
manufacturers of food and non-food products sold under store
brands and private label
brands in supermarkets,
drug stores, mass merchandisers or specialty retailers.
Professionals from retailers,
brand owners or
manufacturers of consumer goods, such as processed foods, beverages, toiletries, over-the-counter
drugs, toys, etc..
There is significant regulatory risk afoot for some Australian infant formula
brands as they await approval from the China Food and
Drug Administration ahead of new regulations starting on January 1 for all
manufacturers of formula products sold into China from around the world.
* Eliminate «pay - for - delay» strategies in which a pharmaceutical company with a
brand name
drug shares profits on that
drug with a generic
drug manufacturer for the remainder of a patent period, effectively eliminating a patent challenge and competition.
Even the
drug's
manufacturer (to whom you should immediately report the reaction — giving them the
brand and lot # — may deny the connection.
«Joint supplements are popular because they enable a consumer to provide relief for their arthritic dog at a fraction of the cost of currently available
drugs and without all the possible side effects,» explains Sinead Imbaro, president of Olympic Olympic
Brands, Inc., a Miami, Fla. - based
manufacturer of NutriFlex
brand joint supplements.
Once a patent expires, other
manufacturers can create generic
drugs but must scientifically prove that their medications perform in the same way as the
branded drug to get FDA approval.
Still, the U.S. made the data exclusivity period so long, it drove at least one
manufacturer to treat a biosimilar as a
brand new
drug and submit to the full FDA approval process.
The
manufacturers are said to have used the KOLs for «unbranded» marketing, thereby evading the strictures of
branded marketing, which is closely supervised by the U.S. Food and
Drug Administration.
On an issue of first impression, however, the California Court of Appeals in Conte v. Wyeth, Inc. rejected this traditional view and held that a
brand - name
manufacturer's duty to warn extends to patients whose prescriptions are filled with the generic version of the
drug.
Following the decision, three other courts adopted this minority position that
brand - name
manufacturers can be liable for injuries caused by the generic version of their
drug.
Early last year, the Alabama Supreme Court ruled that a patient could sue a
brand - name
manufacturer for not warning about a
drug's risks even if the medication involved is a generic version made by another company.
In cases involving the Hatch - Waxman Act and issues involving the expiration of pharmaceutical patents and competition between
branded drug companies and generic
manufacturers, our antitrust litigation graphics can illuminate a complicated industry and a complex regulatory scheme as below:
Pay - for - delay («PFD») agreements are agreements that are intended to delay the market entry of generic
manufacturers with generic
drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original
branded drug).
New California Appellate Decision Makes
Brand Name
Drug Manufacturers Potentially Liable for Injuries Suffered by Consumers of Generic
Drugs
Plaintiff May Sue
Manufacturer of Name -
Brand Prescription
Drug for Injury Allegedly Caused by Different Company's Generic
Drug, Indiana Injury Lawyer Blog, February 28, 2013 Federal Statute Preempts State Products Liability Lawsuit Over Asbestos Exposure, According to Supreme Court: Kurns v. Railroad Friction Products Corp., Indiana Injury Lawyer Blog, October 18, 2012
That's because the warning and usage labels are created by the
brand name
manufacturer, but because
brand name
manufacturers aren't the ones making the
drugs at issue, many courts have held they can not be liable.
Corp. [2] unanimously recognized the doctrine holding that
brand - name prescription
drug manufacturers owe a duty to warn to consumers who use generic
drugs.
[9] The potential lifelong side effects of this
drug were not disclosed within the
brand - name
manufacturer's nor the mirrored generic
manufacturer's warning label.
The court's concern that redress be available to those who ingest generic
drugs by establishing liability to the controlling
brand - name
manufacturer carried the day.
[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic
drug will rely on the label fashioned by the
brand - name
manufacturer and as state law shields failure to warn claims from generic
manufacturers, leaving plaintiffs without recourse for their injuries.
Specifically, in Rafferty v. Merck & Co., Inc., [4] the SJC held that plaintiffs who ingest the generic form of a
drug may bring failure to warn claims against the
brand - name
manufacturer of the
drug if the
brand - name defendant acted recklessly by «intentionally fail [ing] to update the label on its
drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.»
Balancing these competing interests, the court held that, «a
brand - name
manufacturer that controls the contents of the label on a generic
drug owes a duty to consumers of that generic
drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.»
Relevant to the matter considered by the SJC, the
Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&ra
Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «
manufacturer of a generic
drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&ra
drug [to] provide its users with a warning label that is identical to the label of the
brand - name counterpart.»
Mr. Simon also recently represented a generic
brand drug company in an individual case alleging that the
brand name
manufacturer had filed false citizens petitions to delay the entry of the generic
drug unto the market.
Per that law, generic
drugs must be designed the same as their
brand counterparts and come with the same labels and Mutual and other generic medical
manufacturers have said that because they have to be designed and labeled exactly as their
brand equivalents, it is not up to them to modify a generic
drug's design or labeling.
Now, the justices are trying to decide whether generic
drug manufacturers can be sued in state court for design defects - especially when the generic version is an exact copy of its
brand - name counterpart that the federal government had already approved.
[10] Prior to 2006, the price at which
manufacturers could apply to list generic
drugs in the Formulary was capped by regulations under the Actsat effectively 63 % of the price of the
brand - name
drug.
«Any recognition of an outlier theory of liability permitting a generic
drug consumer to bring an action against the
brand manufacturer for an injury allegedly arising from the use of the generic
drug would be plainly at odds with this public policy.»
With generic
drugs, it is not merely foreseeable but certain that the warning label provided by the
brand - name
manufacturer will be identical to the warning label provided by the generic
manufacturer, and moreover that it will be relied on, not only by users of its own product, but also by users of the generic product.
Prescription
drugs that are no longer patent - protected and are sold by
drug manufacturers under a different name than the original
brand name
drug.
Thermafreeze (Red Bank, NJ) 09/2009 — 11/2010 National Sales Manager • Designed and implemented a comprehensive sales and marketing strategy for a retail
manufacturer of alternative ice products • Successfully led the conversion from a commercial
manufacturer to a retail
manufacturer • Established a national tier 1 independent broker network resulting in significantly enhanced corporate reach and revenues • Trained brokers and salespeople in sales and marketing best practices, presentation techniques, and product information • Organized national tradeshows to introduce ThermaFreeze to supermarkets, mass merchandisers, and the
drug store industry • Devised and successfully executed strategies for product image,
branding, packaging, retail displays, and shipping