News

SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, announced it has changed its name to Praxgen Pharmaceuticals. 

SunGen Pharma started its oral and topical research and development center in January 2016, and established its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, New Jersey. Over the past five years, SunGen focused on actively building a company that can both develop a wide range of drug products while maintaining flexibility and dedication to R&D fundamentals.  SunGen is not and has never been affiliated with SUN PHARMA® and/or Sun Pharmaceutical Industries, Ltd.

“Our new name, Praxgen Pharmaceuticals, reflects our commitment to patient health. The path to good health should be practical and accessible to everyone, and we aim to help achieve that through high-quality generic pharmaceuticals,” said Dr. Jim Huang, Co-Founder and Co-CEO of the company. 

Amidst this thrilling name change, Praxgen’s quality remains constant. Praxgen continues to focus on developing exemplary prescription drugs for introduction into the market.  

Dr. Reddy’s Laboratories and SunGen Pharma announced the launch of Desmopressin Acetate Injection USP, 4 mcg/mL Single-dose Ampules, a therapeutic equivalent generic version of DDAVP (desmopressin acetate) Injection, 4 mcg/mL, approved by the U.S. FDA. The DDAVP (desmopressin acetate) Injection USP brand and generic market had U.S. sales of approximately $20.9 million MAT for the most recent twelve months ending in March 2020 according to IQVIA Health. 

Elite Pharmaceuticals, Inc. and SunGen Pharma announced that marketing partner Lannett Company, Inc. ("Lannett"), has commenced product launch of Elite's generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. Adderall XR®, including generic versions, have an estimated IQVIA™ market value of approximately $1.3 billion for the twelve months ending January 2020. Adderall XR® is a once-daily central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). 

SunGen Pharma announced the U.S. launch and commercial shipment of generic version of Bentyl® (Dicyclomine) Injection, in collaboration with Camber Pharmaceuticals, who will be SunGen's distribution and marketing partner. 

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) is a sterile injectable in a 2ml-vial. Dicyclomine is used to treat individuals with severe irritable bowel syndrome and bowel spasms. 

Oakrum and SunGen announced the U.S. launch and commercial shipment of a generic version of Medrol® (Methylprednisolone) in 4 mg tablets.

It is anticipated that the product will serve the retail market with annual sales in the U.S. exceeding $110 million in the aggregate for the 12-month period ending December 31, 2018 according to available data from IQVIA. 

The eighth approved ANDA is for Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g). This drug product is used for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. This drug has annual sales of about 60 million US dollars. 

The seventh approved ANDA is for Fosaprepitant for Injection 150mg/vial. This drug product is used for treatment of cyclic vomiting syndrome and late-stage, chemotherapy-induced vomiting. This is a sub-blockbuster product of over $350M US market size for 2018 according to IQVIA. Emend®’s patent expired on Sep 4th and SunGen obtained its ANDA approval on Sep 5th, which includes it in the first wave of all generic approvals for Emend®. 

SunGen and its partner Elite received FDA approval for a generic version of Adderall XR, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019. 

SunGen announced to launch Bivalirudin for Injection in the near future through their joint venture Peterson Athenex with Athenex Pharmaceuticals (Nasdaq:ATNX). This tentatively approved US ANDA is exclusively licensed from the current ANDA holder, Hainan Shuangcheng Pharmaceuticals. US Market Sales of Bivalirudin for Injection were $81.8M for the year ending December 2018 according to IQVIA data.  Bivalirudin is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. 

The Busulfan Injection is distributed as a prefilled liquid vial with a strength of 6mg/ml in packs of 8 (NDC 70860-216-10). US Market Sales of Busulfan Injection were $33.6M for the year ending December 2018 according to IQVIA data. Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

SunGen Pharma has received its sixth ANDA approval from the FDA for Methylprednisolone tablets, 4 mg. This drug product is a corticosteroid used to treat conditions including arthritis, allergic reactions, and immune system disorders, as well as dermatologic, ophthalmic, respiratory, and gastrointestinal diseases. Methylprednisolone tablets had total U.S. sales of $93 million for 1Q19, and $113 million and $124 million, respectively, for 2018 and 2017 according to IQVIA.

The fourth approved ANDA is a generic version of Deltasone®, an immediate-release Prednisone product with strength at 1 mg. Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. Prednisone Tablets had total U.S. sales of $121 million for the twelve months ending September 30, 2018 according to IQVIA.

The fifth approved ANDA is a generic version of Bentyl®, Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL). It is a sterile injectable solution in 2mL-vial in cartons of 5. Dicylomine is used to treat a certain type of intestinal problem called irritable bowel syndrome. It helps to reduce the symptoms of stomach and intestinal cramping. Dicyclomine injection had total U.S. sales of $17 million for the twelve months ending December 30, 2018 according to IQVIA.

Elite Pharmaceuticals, Inc. announced that it has entered into a license, supply, and distribution agreement with Lannett Company, Inc. Lannett will be the exclusive U.S. distributor for two generic products that Elite and SunGen Pharma co-developed and co-own.   

The second ANDA is Amphetamine Salts, a generic version of Adderall®, an immediate-release tablet used to treat Narcolepsy and Attention Deficit Hyperactivity Disorder (ADHD). Amphetamine Salts had total U.S. sales of $364 million for the twelve months ending September 30, 2018 according to IQVIA.   
The third ANDA is a generic version of Deltasone®, an immediate-release Prednisone product with various strengths 2.5 mg, 5 mg. Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. Prednisone Tablets had total U.S. sales of $121 million for the twelve months ending September 30, 2018 according to IQVIA.  

SunGen announced that it has received approval from the US Food and Drug Administration (FDA) for a generic version of Deltasone®, an immediate-release Prednisone product with various strengths 10 mg, 20 mg, and 50 mg tablets. Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. Prednisone Tablets had total U.S. sales of $121 million for the twelve months ending September 30, 2018 according to IQVIA.  

SunGen has entered into a Manufacturing Agreement (“Agreement”) with Grand River Aseptic Manufacturing (“GRAM”) to manufacture generic injectable pharmaceutical products. 

Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, today announced the launch of Terbutaline Sulfate Injection, the first product launch by Athenex Pharmaceutical Division (APD) through their joint venture with SunGen Pharma LLC, Peterson Athenex. The Terbutaline Sulfate Injection is distributed as a prefilled liquid vial with a strength of 1mg/1ml in packs of 10. The product was launched July 10th, 2017.  

A year after becoming a tenant at the New Jersey Economic Development Authority’s (EDA) Commercialization Center for Innovative Technologies (CCIT) in North Brunswick, biopharmaceutical company SunGen Pharmaceuticals LLC will graduate from the life sciences incubator next week and move into a larger facility in Middlesex County.