Amneal Pharmaceuticals, Inc. is an American publicly traded
generics
Generic or generics may refer to:
In business
* Generic term, a common name used for a range or class of similar things not protected by trademark
* Generic brand, a brand for a product that does not have an associated brand or trademark, other ...
and specialty pharmaceutical company. The company is headquartered in
Bridgewater, New Jersey
Bridgewater Township is a township in Somerset County, New Jersey, United States. The township is both a regional commercial hub for Central New Jersey (home to Bridgewater Commons and different corporate headquarters) and is a bedroom suburb ...
.
History
Amneal Pharmaceuticals was founded in 2002 by brothers Chirag and Chintu Patel. The company manufactured its first prescription product in 2005 and received its first in 2006.
In 2007, the company acquired five divested drugs from
Mylan
Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal ...
which Mylan was forced to sell as part of their acquisition of the generics unit of
Merck KGaA
The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and present in 66 countries. The group includes around 250 companies; the ma ...
. At this time, the company was noted as being a
private company
A privately held company (or simply a private company) is a company whose shares and related rights or obligations are not offered for public subscription or publicly negotiated in the respective listed markets, but rather the company's stock is ...
based in
Paterson, New Jersey
Paterson ( ) is the largest city in and the county seat of Passaic County, in the U.S. state of New Jersey.
After the 2007 acquisition of Akyma Pharmaceuticals, a Glasgow, Kentucky-based regional distributor, Amneal launched its own product label.
In 2008, the company expanded into India with the development of an R&D Centre in Gujarat. Continued expansion in the United States occurred between 2010 and 2016 in New Jersey, New York and Kentucky. As of 2017, the company had grown much of its physical footprint and product base through a series of acquisitions, including the acquisition of assets from Pfizer, Actavis and Warner Chilcott.
In 2018, Amneal Pharmaceuticals LLC merged with Impax Laboratories, Inc. to form Amneal Pharmaceuticals, Inc. Shares of newly public AMRX began trading on the NYSE on May 7, 2018. Concurrent with the Impax merger, Amneal acquired Gemini Laboratories for $117 million, including Unithroid, Gemini's lead product for treating hypothyroidism.
In December 2019, Amneal announced it had entered into an agreement to acquire a majority interest in AvKARE, a private label provider of generic pharmaceuticals in the US federal agency sector. Under the agreement, AvKARE would continue to operate as an independent subsidiary of Amneal.
As of June 2020, co-founders Chirag and Chintu Patel served as co-CEOs of the company, while Paul Meister served as chairman.
In January 2021, the business announced it would acquire 98% of Kashiv BioSciences LLC and its drug delivery platforms.
In January 2022, Amneal announced it would acquire Saol Therapeutics
Baclofen
Baclofen, sold under the brand name Lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. It may also be used for hiccups and muscle spasms near the end of life. It is ta ...
franchise for around $83.5 million, plus future royalties.
Formation of Amneal Pharmaceuticals Inc
In 2018, Amneal Pharmaceuticals LLC merged with Impax Laboratories, Inc. to form Amneal Pharmaceuticals, Inc. The FTC described the merger as having a value of US$1.45 billion, and required the companies to divest several marketed products and development projects as a condition of the approval. The merger was completed in May 2018, with shares of IPXL ceasing trading on NASDAQ on May 4 and shares of AMRX commencing trading on the NYSE on May 7. The company's predecessor entity, privately held Impax Pharmaceuticals, Inc., was founded in 1995. Publicly traded Global Pharmaceutical Corporation and Impax Pharmaceuticals, Inc. completed a reverse merger, forming Impax Laboratories, Inc. on December 14, 1999.
List of mergers and acquisitions
The following is an illustration of the company's major mergers and acquisitions and historical predecessors:
*Amneal Pharmaceuticals, Inc.
** Amneal Pharmaceuticals (Merged 2018)
***Amneal Pharmaceuticals LLC
****Akyma Pharmaceuticals (Acq. 2007)
***Impax Laboratories, Inc.
**Gemini Laboratories (Acq. 2018)
**AvKARE (Acq. 2019)
**Kashiv BioSciences LLC (Acq. 2021)
Operations
Research and development
As of July 2019, Amneal operated seven Research and Development (R&D) centers in the United States, India and Ireland. According to the company, 10% of net revenue is invested in R&D.
After the Impax merger, Amneal was reportedly the fifth largest U.S. generic drug maker in the United States with a generics portfolio inclusive of more than 200 product families, approximately 149 ANDAs filed with the FDA, and 135 projects in development at that time.
The company's research and development activity in the biosimilar space has included a 2017 partnership with Adello Biologics (for the collaborative development of Neupogen and Neuasta biosimilars) and a 2018 partnership with mAbxience (for the development of Avastin biosimilars).
Pharmaceutical products
Amneal's Generics Division focuses on a broad range of therapeutic areas, including solid oral dosage products and alternative dosage form products.
The company's Specialty Pharma Division is focused on the development of proprietary branded pharmaceutical products for the treatment of Central Nervous System disorders, Endocrine disorders and other select specialty segments.
This division commercializes several branded pharmaceutical products, including Rytary, an extended release oral capsule formulation for the treatment of Parkinson's disease, Unithroid, for treatment of hypothyroidism, Emverm, for treatment of certain gastrointestinal infections, and Zomig Nasal Spray, for the acute treatment of migraines.
As of July 2019, the company owned ten manufacturing sites and seven R&D sites in the United States, Ireland and India.
In 2020, in response to the interest in
chloroquine and hydroxychloroquine during the COVID-19 pandemic
Chloroquine and hydroxychloroquine are anti-malarial medications also used against some auto-immune diseases. Chloroquine, along with hydroxychloroquine, was an early experimental treatment for COVID-19. Neither drug prevents SARS-CoV-2 in ...
, and before the United States Food and Drug Administration's emergency use authorization was withdrawn, Amneal ramped up production.