Defendant

Oncogen Pharma (Malaysia) Sdn. Bhd.

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2022
Top venue
D. New Jersey
1 case

Company profile

Oncogen Pharma (Malaysia) Sdn. Bhd. — commonly "Oncogen Pharma" — is a private Malaysian pharmaceutical manufacturer headquartered at the Hicom Glenmarie Industrial Park in Shah Alam, Selangor, with manufacturing operations in Bandar Enstek, Negeri Sembilan. It was established in 2015 and is a wholly owned subsidiary of the UAE-based Scitech International group (Dubai); MIDA reports it operates alongside affiliate Novugen Pharma, and the oncology business was earlier known as Novugen Oncology. MIDA stated the company employed more than 200 people as of 2021, with a stated goal of 1,000 by 2030. Revenue figures are not publicly disclosed by the company; third-party estimates vary too widely to rely on.

Operations. Oncogen Pharma is a vertically integrated, research-based oncology pharmaceutical maker — the company describes itself as developing and manufacturing oncology active pharmaceutical ingredients (APIs) and finished dosage forms to FDA/EU standards, including a high-potency containment manufacturing facility. It opened an oncology API R&D centre in Glenmarie in 2016 and a containment oncology R&D centre in 2018. Commercially, its first U.S. ANDA approval was for abiraterone acetate 250 mg and 500 mg tablets (January 2022), marketed in the U.S. by affiliate Novugen Pharma (USA) LLC; it has also filed an ANDA for generic lenalidomide (Revlimid).

Litigation posture. Oncogen Pharma appears in the tracked data only as a defendant (0 plaintiff, 1 defendant), which is consistent with an operating generic manufacturer defending Hatch-Waxman suits rather than a patent assertion entity. Its single tracked case was filed in the District of New Jersey — the standard venue for Celgene's ANDA litigation, not a plaintiff-friendly forum like the Eastern District of Texas.

Notable case. Celgene Corporation v. Oncogen Pharma (Malaysia) Sdn. Bhd., 2:22-cv-02952 (D.N.J., filed May 20, 2022), was an ANDA patent case concerning Revlimid (lenalidomide) patents. The parties entered a consent judgment on May 25, 2022 — five days after filing — enjoining Oncogen from infringing the patents-in-suit until expiration unless authorized by Celgene, while preserving Oncogen's Paragraph IV certification and leaving FDA approval of its ANDA unrestricted.