For pharmaceutical companies, it takes billions of dollars to develop a new medication, along with years of research and revisions to achieve regulatory approval. Drug manufacturers want to maintain the profits and rights to their flagship medications, attempting to protect profits, patent products and block less expensive generic versions.

That’s one of the reasons Americans pay the most for prescription drugs in the world.

Congress passed a law requiring drug companies to provide samples of their products, which would allow for the development of generic equivalents. This intention is to increase competition and ultimately lower drug prices.

Samples are required for bioequivalence testing, which is necessary for a generic drug to be approved. By refusing to provide samples, the companies are delaying the formulation and availability of cheaper options.

Which companies are blocking generic drugs?

The U.S. Food and Drug Administration (FDA) has publicly released a list of companies that may be intentionally delaying generic drugs. As part of the FDA’s Drug Competition Action Plan (DCAP) to support government efforts for affordable medications, the agency is focusing on transparency.

The FDA has received more than 150 inquiries from generic drug makers looking to access samples from manufacturers. Some companies that have yet to comply include GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals.

What drugs are being blocked from generic development?

Many of the drugs manufactured by these companies are necessary or life-saving medications. One medication, Revlimid (lenalidomide), which treats multiple myeloma and other related diseases, currently costs $20,000 a month. Tracleer (bosentan), which is used to treat pulmonary arterial hypertension, costs $12,000 a month, according to GoodRx.

Other drugs include Truvada, the blockbuster medication used to prevent HIV infection, and Clozaril, which is used to treat schizophrenia and suicidal thinking. Also listed is Accutane, a treatment for severe cystic acne.

To urge compliance from manufacturers, the FDA has listed the companies who have yet to provide samples for generics:

Drug NameDrug Manufacturer
Absorica (isotretinoin)RANBAXY INC/SUN PHARMACEUTICAL INDUSTRIES INC
Abstral (fentanyl citrate)GALENA BIOPHARMA
Accutane (isotretinoin)ROCHE PALO ALTO LLC
Adempas (riociguat)BAYER HEALTHCARE PHARMACEUTICALS INC
Afinitor (everolimus)NOVARTIS PHARMACEUTICALS CORP
Amnesteem (isotretinoin)MYLAN PHARMACEUTICALS INC
Ampyra (dalfampridine)ACORDA THERAPEUTICS INC
Brilinta (ticagrelor)ASTRAZENECA LP
Claravis (isotretinoin)TEVA PHARMACEUTICALS USA
Clozaril (clozapine)HERITAGE LIFE SCIENCES BARBADOS INC
Cystadane (betaine hydrochloride)ORPHAN EUROPE SARL
Embeda (morphine sulfate; naltrexone hydrochloride)ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS
Entereg (alvimopan)CUBIST PHARMACEUTICALS INC
Exjade (deferasirox)NOVARTIS PHARMACEUTICALS CORP
Fazaclo ODT (clozapine)JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
Fentora (fentanyl citrate)CEPHALON INC
Ferriprox (deferiprone)APOPHARMA INC
Firazyr (icatibant acetate)SHIRE ORPHAN THERAPIES INC
Gattex Kit (teduglutide recombinant)NPS PHARMACEUTICALS INC
Gilotrif (afatinib dimaleate)BOEHRINGER INGELHEIM
H.P. Acthar Gel (corticotropin)QUESTCOR PHARMACEUTICALS INC
Hemabate (carboprost tromethamine)PHARMACIA AND UPJOHN CO
Juxtapid (lomitapide mesylate)AEGERION PHARMACEUTICALS INC
Korlym (mifepristone)CORCEPT THERAPEUTICS INC
Kuvan (sapropterin dihydrochloride)BIOMARIN PHARMACEUTICAL INC
Letairis (ambrisentan)GILEAD SCIENCES INC
Methadone Hydrochloride (methadone hydrochloride)ROXANE LABORATORIES INC
Mifeprex (mifepristone)DANCO LABORATORIES LLC
Nexavar (sorafenib tosylate)BAYER HEALTHCARE PHARMACEUTICALS INC
Onsolis (fentanyl citrate)MEDA PHARMACEUTICALS INC
Opsumit (macitentan)ACTELION PHARMACEUTICALS LTD
Orfadin (nitisinone)SWEDISH ORPHAN BIOVITRUM AB PUBL
Pomalyst (pomalidomide)CELGENE CORP
Promacta (eltrombopag olamine)GLAXOSMITHKLINE
Qsymia (phentermine hydrochloride; topiramate)VIVUS INC
Ravicti (glycerol phenylbutyrate)HYPERION THERAPEUTICS INC
Revlimid (lenalidomide)CELGENE CORP
Sabril (vigabatrin) for solutionLUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC
Sabril (vigabatrin) tabletLUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC
Subsys (fentanyl)INSYS THERAPEUTICS INC
Tasigna (nilotinib hydrochloride monohydrate)NOVARTIS PHARMACEUTICALS CORP
Tecfidera (dimethyl fumarate)BIOGEN IDEC INC
Thalomid (thalidomide)CELGENE CORP
Tikosyn (dofetilide)PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
Tracleer (bosentan)ACTELION PHARMACEUTICALS LTD
Truvada (emtricitabine; tenofovir disoproxil fumarate)GILEAD SCIENCES INC
Tykerb (lapatinib ditosylate)SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
Veletri (epoprostenol sodium)ACTELION PHARMACEUTICALS LTD
Xenazine (tetrabenazine)VALEANT INTERNATIONAL BERMUDA/VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Zavesca (miglustat)ACTELION PHARMACEUTICALS LTD
Zortress (everolimus)NOVARTIS PHARMACEUTICALS CORP

 

For more information, please review the Reference Listed Drug (RLD) Access Inquiries or visit FDA. gov.