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  1. Home
  2. Brands
  3. Healthcare & Pharmaceuticals
  4. CellCept
CellCept logo
Healthcare & Pharmaceuticals

Who Owns CellCept?

CellCept (mycophenolate mofetil) is owned by Roche Holding AG (SIX: ROG), which acquired the drug through its 1994 purchase of Syntex Laboratories. The FDA first approved CellCept on May 3, 1995 for preventing kidney transplant rejection. Roche is headquartered in Basel, Switzerland and trades on the SIX Swiss Exchange under ROG.

Parent Company

Roche

Acquired

1994

Status

Publicly Traded

Headquarters

Basel, Switzerland

CellCept Timeline

1896
Roche

Parent company established in Basel, Switzerland

Company Founded
1994
Acquired by Roche

Roche acquired CellCept

Acquired
1995

CellCept

Founded by Syntex Laboratories

Founded
GlobalOfficial Website

Who Owns CellCept?

  • Parent Company: Roche
  • Ownership Type: Brand division
  • Acquisition Year: 1994
  • Company Type: Publicly Traded
  • Stock Ticker: SIX: ROG
BrandParent CompanyOwnership Type
CellCeptRocheBrand division

Where to Buy

Disclosure: We may earn commission from purchases
AmazonCellCept on Amazon

History of CellCept

  • Founded: 1995
  • Founders: Syntex Laboratories
  • Acquired by Roche: 1994

Mycophenolate mofetil was developed by Syntex Laboratories, a pharmaceutical company based in Palo Alto, California. Syntex was best known for synthesizing norethindrone, the first oral contraceptive, in 1951. The company developed mycophenolate mofetil as an immunosuppressant that inhibits inosine monophosphate dehydrogenase (IMPDH), an enzyme required for T-cell and B-cell proliferation.

The FDA approved CellCept on May 3, 1995, for the prevention of acute kidney transplant rejection. It was the first novel transplant drug launched in the United States since ciclosporin A was introduced by Sandoz in 1983. The NDA was supported by data from three double-blind controlled clinical trials, each involving approximately 500 newly transplanted recipients. Efficacy was determined by comparing mycophenolate mofetil with azathioprine (in one trial) or placebo (in two trials) in patients receiving standard immunosuppressive therapy.

Roche acquired Syntex in 1994 for approximately $2.1 billion, before CellCept had received FDA approval. The acquisition gave Roche ownership of CellCept and the drug's development pipeline. Roche Laboratories launched CellCept in the U.S. in June 1995 through its subsidiary Hoffmann-La Roche, based in Nutley, New Jersey.

The FDA subsequently approved CellCept for additional indications: adult heart transplant rejection prophylaxis on February 11, 1998; adult liver transplant on July 28, 2000; pediatric kidney transplant on December 20, 2000; and pediatric heart and liver transplants on June 6, 2022. The drug is available in capsule, tablet, oral suspension, and intravenous formulations.

CellCept became a cornerstone of transplant immunosuppressive regimens worldwide. It is used in combination with other immunosuppressants, typically calcineurin inhibitors (ciclosporin or tacrolimus) and corticosteroids. Generic mycophenolate mofetil is available from multiple manufacturers.

About Roche

Roche operates through two main business divisions: Pharmaceuticals and Diagnostics, creating a unique integrated healthcare company that combines treatment and diagnostic capabilities. This dual focus enables Roche to deliver personalized healthcare solutions, matching patients with the most effective treatments based on diagnostic information and molecular characteristics.

The Pharmaceuticals division develops and manufactures prescription medicines across multiple therapeutic areas, with particular strength in oncology, immunology, neuroscience, infectious diseases, and rare diseases. Roche's pharmaceutical portfolio includes both established blockbuster products and innovative new treatments that address significant unmet medical needs. The division maintains a global research and development network with facilities across multiple continents, investing billions annually in pharmaceutical innovation, clinical trials, and regulatory approvals.

The Diagnostics division produces laboratory testing systems, molecular diagnostics, and point-of-care testing devices that support healthcare professionals in disease detection, monitoring, and treatment selection. Roche's diagnostic capabilities include automated laboratory systems, molecular testing platforms, and digital health solutions. The division's integrated approach with pharmaceuticals creates unique advantages in personalized medicine, enabling precise treatment selection based on diagnostic information.

Roche's business philosophy emphasizes innovation, patient-centricity, and sustainable value creation. The company maintains a strong focus on research and development, with approximately 20% of pharmaceutical revenues invested in R&D activities. This investment supports a robust pipeline of new treatments and diagnostic solutions, with 10 key molecules advancing into phase III development in 2025 alone.

Financial performance in 2025 demonstrated the strength of Roche's integrated business model. The company reported 7% sales growth at constant exchange rates to CHF 61.5 billion, with the Pharmaceuticals Division achieving 9% growth and the Diagnostics Division growing 2%. Core operating profit increased by 13%, reflecting operational efficiency and strong demand for both pharmaceutical and diagnostic solutions.

Key growth drivers in 2025 included Phesgo for breast cancer, Xolair for food allergies, Ocrevus for multiple sclerosis, Hemlibra for hemophilia A, and Vabysmo for severe eye diseases. These products demonstrate Roche's strength across multiple therapeutic areas and its ability to deliver innovative treatments that address significant patient needs.

Looking toward 2026, Roche expects Group sales growth in the mid single digit range and core earnings per share growth in the high single digit range at constant exchange rates. The company plans to further increase its dividend to CHF 9.80 per share, which would mark the 39th consecutive dividend increase if approved by shareholders. For 2026, Roche is shifting focus from consolidation to optimization, emphasizing internal pipeline development and R&D process improvements to enhance productivity and decision-making.

Roche's strategic priorities include investing in programs with potential to redefine care standards, particularly in oncology, neuroscience, and immunology. The company maintains a $10 billion annual budget for potential acquisitions and partnerships, prioritizing strategic fit and scientific differentiation over transaction size. This approach reflects Roche's commitment to long-term value creation and sustainable growth while maintaining operational discipline.

  • Founded: 1896
  • Headquarters: Basel, Switzerland
  • Company Type: Publicly Traded
  • Stock: SIX: ROG
  • Revenue: CHF 61.5 billion (FY2025)
  • Employees: Approximately 101,000

Visit Roche website

View full company profile for Roche

Where Is CellCept Made / Based?

  • Headquarters: Basel, Switzerland

CellCept Categories & Tags

ImmunosuppressionTransplantOrgan RejectionPrescriptionImmunology

CellCept Sustainability & Ethics

CellCept is manufactured and distributed under Roche's corporate ESG framework. Roche's sustainability and ethics practices cover environmental targets, clinical research standards, and patient safety.

Environmental Targets: Roche has committed to achieving net-zero carbon emissions by 2045. The company's near- and long-term climate targets have been validated by the Science Based Targets initiative (SBTi). Roche reports its climate-related risks following the Task Force on Climate-related Financial Disclosures (TCFD) framework.

Clinical Research Ethics: Roche conducts clinical trials under FDA, EMA, and ICH-GCP regulations. The company registers trials publicly through ClinicalTrials.gov and the EU Clinical Trials Register. CellCept has been studied in long-term transplant outcomes research, with results published in peer-reviewed journals including the New England Journal of Medicine.

Patient Safety: CellCept carries a boxed warning for pregnancy risks. Mycophenolate mofetil can cause first-trimester miscarriages and congenital malformations. The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) program for CellCept, which includes pregnancy prevention counseling and testing for women of childbearing potential. Additional warnings cover increased risk of serious infections, lymphoma, and skin cancers.

Drug Access: Roche offers patient assistance programs for eligible individuals in the United States through Genentech Access Solutions. The company participates in tiered pricing programs in developing countries for its on-patent medicines. Generic mycophenolate mofetil is widely available, which has reduced treatment costs for transplant patients.

CellCept Recalls & Controversies

Pregnancy Risks and Boxed Warning: CellCept carries an FDA boxed warning for pregnancy risks. Mycophenolate mofetil can cause first-trimester miscarriages and congenital malformations. The FDA requires a REMS (Risk Evaluation and Mitigation Strategy) program that includes pregnancy prevention counseling, contraception requirements, and pregnancy testing for women of childbearing potential. Roche and the FDA issued updated warnings in 2007 and subsequent years to strengthen pregnancy risk communications.

FDA Safety Communications: The FDA has issued multiple safety communications regarding CellCept. In addition to pregnancy risks, warnings cover increased risk of serious infections (including BK virus-associated nephropathy and progressive multifocal leukoencephalopathy), lymphoma, and skin cancers. Long-term immunosuppression with CellCept requires regular monitoring by transplant specialists.

Adverse Reactions: Common adverse reactions include diarrhea, vomiting, constipation, abdominal pain, and leukopenia. Serious adverse reactions include sepsis, tissue-invasive cytomegalovirus infection, and bone marrow suppression. Healthcare providers must balance organ rejection prevention against immunosuppression risks.

Generic Competition and Patent Expiration: CellCept's U.S. patent expired in 2009. Teva Pharmaceuticals launched the first generic mycophenolate mofetil in the United States in May 2009. Roche attempted to extend market exclusivity through legal challenges but was unsuccessful. The introduction of generics significantly reduced CellCept's revenue for Roche.

REMS Compliance: The FDA has monitored Roche's compliance with the REMS program for CellCept. The program requires that healthcare providers counsel patients about pregnancy risks and that pharmacies provide a Medication Guide with each CellCept prescription. Compliance with REMS programs has been a subject of FDA inspection and enforcement.

Brands Owned by Roche

ActivaseHealthcare Pharmaceuticals

Activase

Owned by Roche

Activase (alteplase) is a prescription thrombolytic medication manufactured by Genentech, a wholly-owned subsidiary of Roche. Used to treat acute ischemic stroke, heart attack, and pulmonary embolism.

pharmaceuticalthrombolyticstroke-treatment
TNKaseHealthcare Pharmaceuticals

TNKase

Owned by Roche

TNKase (tenecteplase) is a prescription thrombolytic medication manufactured by Genentech, a wholly-owned subsidiary of Roche. Approved for acute ischemic stroke and myocardial infarction, administered as a single five-second IV bolus.

pharmaceuticalthrombolyticstroke-treatment
View all brands owned by Roche

Frequently Asked Questions About CellCept

Sources & Further Reading

  • [FDA: CellCept Approval History (Drugs.com)](
  • [FDA: CellCept Prescribing Information](
  • [FDA: CellCept Drug Approval Package (NDA 50-722)](
  • [The Pharmaletter: CellCept Launched in 1st Market](
  • [Roche Official Website](
  • [CellCept Official Website](
  • [Roche Sustainability Report](
  • [Science Based Targets initiative](
  • [American Society of Transplant Surgeons](
  • [National Kidney Foundation](

Competitors to CellCept

These competing brands operate in the same categories and provide similar products or services. Compare key attributes to understand market positioning and competitive landscape.

BrandParent CompanyCountryFoundedMarket PositionPrimary MarketGender Target
EnvarsusEnvarsus
Takeda
Japan
2013
Mass marketUnited statesAll Genders
GilenyaGilenya
Novartis
Switzerland
2010
Declining brandedGlobalAll-consumers

Learn More About Competitors

EnvarsusHealthcare Pharmaceuticals

Envarsus

Owned by Takeda Pharmaceutical Company

Extended-release tacrolimus tablet for preventing organ rejection in kidney and liver transplant recipients. Marketed by Takeda Pharmaceutical Company.

transplantationimmunosuppressionorgan-rejection
GilenyaHealthcare Pharmaceuticals

Gilenya

Owned by Novartis

Prescription oral medication for relapsing-remitting multiple sclerosis (RRMS) and secondary progressive MS. Developed and marketed by Novartis. FDA-approved in 2010 as the first oral disease-modifying therapy for MS. Generic fingolimod entered the US market in 2024 after patent expiration.

immunologymultiple-sclerosisprescription

Competitive Analysis

Market Positioning: CellCept competes with 2 brands in the same categories, ranging from mass market to luxury positioning.

Geographic Distribution: Competitors are headquartered across multiple regions, indicating global competition in this market segment.

Brand Heritage: Competitor brands range from established heritage brands to newer market entrants, with founding years spanning several decades.

Independent Alternatives to CellCept

Looking for brands with different ownership structures? These similar brands are not owned by Roche, giving you alternative choices that support different corporate structures.

Pharmacy DirectHealthcare Pharmaceuticals

Pharmacy Direct

Owned by Chempro Chemists

Australian online pharmacy operated by Chempro Chemists from Molendinar, Queensland. Offers prescription medications, health products, and wellness items through digital platforms and mail-order delivery.

online-pharmacymail-orderdigital-health
Privately Owned

Pharmacy Direct is privately owned, unlike CellCept which is under a publicly traded parent company.

RetavaseHealthcare Pharmaceuticals

Retavase

Owned by EKR Therapeutics, Inc.

Retavase (reteplase) is a prescription thrombolytic medication indicated for acute ST-elevation myocardial infarction. Administered as two 10-unit intravenous bolus injections 30 minutes apart. Currently marketed by Chiesi USA.

pharmaceuticalthrombolyticreteplase
Privately Owned

Retavase is privately owned, unlike CellCept which is under a publicly traded parent company.

TirosintHealthcare Pharmaceuticals

Tirosint

Owned by IBSA Institut Biochimique S.A.

IBSA Institut Biochimique SA's branded levothyroxine softgel capsule (Tirosint) and liquid solution (Tirosint-SOL), FDA approved for hypothyroidism, formulated without dyes, gluten, lactose, alcohol, or sugar, providing an excipient-free alternative to conventional levothyroxine tablets for patients with sensitivities or absorption issues.

levothyroxinehypothyroidismthyroid
Privately Owned

Tirosint is privately owned, unlike CellCept which is under a publicly traded parent company.

AlconHealthcare Pharmaceuticals

Alcon

Owned by Alcon Inc.

Independent publicly traded global eye care company headquartered in Geneva, Switzerland, specializing in surgical equipment, contact lenses, and ophthalmic products. Spun off from Novartis in April 2019.

eye-carecontact-lensesophthalmic
Publicly Traded

Alcon operates independently without a large parent corporation.

Bausch + LombHealthcare Pharmaceuticals

Bausch + Lomb

Owned by Bausch + Lomb Corporation

Global eye health company and contact lens manufacturer founded in 1853, known for ULTRA, Biotrue One Day, and INFUSE lens lines. Public on NYSE and TSX under BLCO.

contact-lensesvision-carebausch-lomb
Publicly Traded

Bausch + Lomb operates independently without a large parent corporation.

GE HealthCareHealthcare Pharmaceuticals

GE HealthCare

Owned by GE HealthCare Technologies Inc.

Independent publicly traded healthcare technology company spun off from General Electric in January 2023, providing medical imaging, diagnostics, and healthcare IT solutions globally.

healthcare-technologymedical-imagingdiagnostics
Publicly Traded

GE HealthCare operates independently without a large parent corporation.

Roche Stock Information

Jobs at Roche

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Last reviewed: August 1, 2026 · Reviewed by Who Brands Editorial Team