Industry Background:
A branded generic is a generic drug that has been given a name rather than the chemical name after going through the ANDA phase. After a patent expires, these branded generic drugs may be manufactured by a generic drug company or by the original manufacturer. The increase in the number of expired patents is the primary driver of the growth of branded generics. A rise in the number of patients with chronic and acute illnesses necessitates the use of marketed generics. Furthermore, in their search for low-cost, reliable pharmaceuticals, they become aware of the idea of branded generics. As a result, the branded generics market's growth potential is expanding. Cardiac arrests, diabetes, and hypertension account for a large percentage of all deaths worldwide. Anti-hypertensive medications have been in high demand from all over the world. This necessitates the use of cost-effective medications, and branded generics have proved to be a viable option.This growth is primarily driven by Increasing Demand For Anti-Hypertensive Drugs.
Globally, a noticeable market trend is evident Recent Relaxations Granted by the Aforementioned Authorities. Major Players, such as Mylan N.V (United States), Novartis AG (Switzerland), Teva Pharmaceutical Industries Ltd. (Israel), Pfizer Inc. (United States), Sun Pharmaceutical Industries Ltd. (India), Aspen Pharmacare (South Africa), Abbott Laboratories (United States), Valeant Pharmaceuticals International, Inc. (Canada), Sanofi (France) and GlaxoSmithKline Pharmaceuticals (United Kingdom) etc have either set up their manufacturing facilities or are planning to start new provision in the dominated region in the upcoming years.
January 2020 – Greenstone, a wholly owned subsidiary of Pfizer Inc., announced a supply agreement with Roman, an innovative digital healthcare clinic, to offer Roman members access to the only FDA-approved authorized generic version of Viagra (sildenafil citrate).
Regulatory Insights:
In the U.S Federal Food Drugs and Cosmetics Act (FD&C Act) and Controlled Substances Act, or CSA govern all the activities related to branded generics including development, manufacturing, testing, labelling, distribution, advertising & promotion, sales, import export of generic products. The manufacturer of branded generic products required to obtain abbreviated new drug application (ANDA) approval under section 505(b)(2) of Federal Food Drug and Cosmetics Act
Market Drivers
- Increasing Demand For Anti-Hypertensive Drugs
Market Trend
- Recent Relaxations Granted by the Aforementioned Authorities
Restraints
- Misapplication of Risk Evaluation and Mitigation Strategies (REMS) To Delay Generic Market Entry
Opportunities
Growing Number Of Patents Expired And Expiring For Branded Drugs and Simple Marketing Authorization Procedures, Changing Medicine Practices, Greater Profit Margin
Challenges
Various Regulations Need To Be Followed and Complications In Getting License For Certain Products
AMA Research follow a focused and realistic research framework that provides the ability to study the crucial market dynamics in several regions across the world. Moreover, an in-depth assessment is mostly conducted by our analysts on geographical regions to provide clients and businesses the opportunity to dominate in niche markets and expand in emerging markets across the globe. This market research study also showcase the spontaneously changing Players landscape impacting the growth of the market. Furthermore, our market researchers extensively analyse the products and services offered by multiple players competing to increase their market share and presence.
Customization in the Report
AMA Research features not only specific market forecasts, but also include significant value-added commentary on:
- Market Trends
- Technological Trends and Innovations
- Market Maturity Indicators
- Growth Drivers and Constraints
- New Entrants into the Market & Entry/Exit Barriers
- To Seize Powerful Market Opportunities
- Identify Key Business Segments, Market Proposition & Gap Analysis
Against this Challenging Backdrop, Branded Generics Study Sheds Light on
— The Branded Generics Market status quo and key characteristics. To end this, Analyst at AMA organize and took survey of the Branded Generics industry Players. The resultant snapshot serves as a basis for understanding why and how the industry can be expected to change.
— Where Branded Generics industry is heading and what are the top priorities. Insights are drawn from financial analysis, the survey and interviews with key executives and industry experts.
— How every company in this diverse set of Players can best navigate the emerging competition landscape and follow a strategy that helps them position to hold value they currently claim, or capture the new addressable opportunity.