Cyclosporine

Prevents organ rejection in kidney, liver, and heart allogeneic transplants. Sold as Restasis, Sandimmune, Neoral, Restasis Multidose, Cequa and 2 more. Every FDA application for this active ingredient: 14 branded and 24 generic.

As of Nov 15, 2026, FDA lists 38 applications for Cyclosporine (sold as Restasis, Sandimmune, Neoral and others), first approved Nov 14, 1983, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 14, 1983
Applications: 38
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.67B
Orphan exclusivity until: Jun 23, 2028

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Restasis	Part D	$1.02B	-21%	355,558
Cyclosporine	Part D	$455M	+49%	458,096
Cequa	Part D	$96.6M	+26%	37,820
Restasis Multidose	Part D	$53.5M	-17%	20,217
Vevye	Part D	$40.8M	+209%	13,306
Cyclosporine (J7515)	Part B	$5.2M	-8%	5,481
Cyclosporine (J7502)	Part B	$2.2M	-9%	2,343
Sandimmune	Part D	$529K	+14%	115
Verkazia	Part D	$120K	-54%	36

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CYCLOSPORINE 0.05% EYE EMULSION: $1.01 per unitGeneric · -48% in a year
CYCLOSPORINE 100 MG CAPSULE: $7.40 per unitGeneric · +1% in a year
CYCLOSPORINE 25 MG CAPSULE: $2.51 per unitGeneric · -7% in a year
RESTASIS 0.05% EYE EMULSION: $10.31 per unitBrand · 0% in a year
NEORAL 100 MG GELATIN CAPSULE: $11.77 per unitBrand · +4% in a year
NEORAL 25 MG GELATIN CAPSULE: $2.95 per unitBrand · +4% in a year
RESTASIS MULTIDOSE 0.05% EYE: $112.38 per MLBrand · 0% in a year
CEQUA 0.09% SOLUTION: $10.39 per unitBrand · +3% in a year
VEVYE 0.1% EYE DROP: $379.87 per MLBrand · +3% in a year

Orphan Designations (FDA)

5 designations, 1 approved for the designated use; see all orphan designations

Prophylaxis of graft-versus-host diseaseSigmoid Pharma Limited · designated Feb 17, 2009 · withdrawn
Treatment of graft-versus-host diseaseSigmoid Pharma Limited · designated Feb 17, 2009 · withdrawn
Treatment of vernal keratoconjunctivitisHarrow Eye, LLC · designated May 4, 2007 · approved Jun 23, 2021 · exclusive to Jun 23, 2028
Prophylaxis of organ rejection in patients receiving allogeneic lung transplantAPT Pharmaceuticals, Inc. · designated Nov 25, 2003
Treatment of acute rejection in patients requiring allogenic lung transplantsAPT Pharmaceuticals, Inc. · designated Nov 25, 2003

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Neoral solution NeoralDrugs with a new indication and a new dosage for the treatment of atopic dermatitis (in patients in whom conventional therapies are not sufficiently effective). · Novartis Pharma K.K. · Oct 16, 2008

Clinical Trials

145 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Lanoracopan to Prevent Acute GVHD Following Haploidentical Peripheral Blood Stem Cell Transplantation: A Prospective Multicenter Single-Arm Exploratory StudyHematologic Malignancies, Haploidentical Peripheral Blood Stem Cell Transplantation · The First Affiliated Hospital of Soochow University	Phase 2	Not yet recruiting	Nov 9, 2026
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCTAcute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation · Peking University People's Hospital	Not applicable	Not yet recruiting	Nov 5, 2026
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic SolutionDry Eye Disease (DED), Contact Lens Discomfort (CLD) · Ocular Aesthetics, LLC dba Ocular Clinical Trials	Not applicable	Recruiting	Oct 29, 2026
Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLCNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor · NYU Langone Health	Phase 2	Recruiting	Oct 15, 2026
A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy ParticipantsHealthy Participants, Gastrointestinal Neoplasms · GlaxoSmithKline	Phase 1	Not yet recruiting	Oct 7, 2026
Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous NephropathyMembranous Nephropathy · Peking University First Hospital	Phase 2 / Phase 3	Recruiting	Oct 6, 2026
Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung DiseaseSjögren's Disease, Interstitial Lung Disease · Peking University People's Hospital	—	Recruiting	Sep 28, 2026
Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous NephropathyPrimary Membranous Nephropathy · BioRay Pharmaceutical Co., Ltd.	Phase 3	Not yet recruiting	Sep 21, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 14, 1983	SandimmuneNDA 50574 · New dosage form	Novartis	44	Marketed
Nov 14, 1983	SandimmuneNDA 50573 · New molecular entity	Novartis	35	Marketed
Mar 2, 1990	SandimmuneNDA 50625 · New dosage form	Novartis	41	Marketed
Jul 14, 1995	NeoralNDA 50716 · New dosage form	Novartis	27	Marketed
Jul 14, 1995	NeoralNDA 50715 · New dosage form	Novartis	22	Marketed
May 22, 1997	NeoralNDA 50735 · TYPE 6	Novartis	1	Marketed
May 22, 1997	NeoralNDA 50736 · TYPE 6	Novartis	1	Marketed
Jun 19, 1997	NeoralNDA 50737 · TYPE 6	Novartis	1	Marketed
Jun 19, 1997	NeoralNDA 50738 · TYPE 6	Novartis	1	Marketed
Oct 29, 1999	CyclosporineANDA 65004	Hikma	4	Marketed
Jan 13, 2000	CyclosporineANDA 65017	Sandoz	14	Marketed
Mar 3, 2000	CyclosporineANDA 65025	Abbvie	19	Discontinued
May 12, 2000	GengrafANDA 65003	Abbvie	14	Marketed
Dec 20, 2000	CyclosporineANDA 65044	Dr Reddys Labs SA	7	Marketed
Dec 18, 2001	CyclosporineANDA 65054	Dr Reddys Labs SA	7	Discontinued
May 9, 2002	CyclosporineANDA 65040	Apotex	6	Marketed
Dec 23, 2002	Restasis, Restasis MultidoseNDA 50790 · New dosage form	Abbvie	14	Marketed
Oct 7, 2003	CyclosporineANDA 65151	Padagis US	5	Discontinued
Oct 10, 2003	RestasisNDA 21023 · New dosage form	Allergan	0	Marketed
Sep 17, 2004	CyclosporineANDA 65133	Pharmobedient Cnsltg	3	Discontinued
Jan 5, 2005	CyclosporineANDA 65167	Esjay Pharma	6	Discontinued
Mar 25, 2005	CyclosporineANDA 65078	Ivax Sub Teva Pharms	5	Marketed
Mar 29, 2005	CyclosporineANDA 65110	Ivax Sub Teva Pharms	5	Marketed
Aug 14, 2018	CequaNDA 210913 · New formulation or manufacturer	Sun Pharm	1	Marketed
Jul 10, 2019	CyclosporineANDA 210721	Apotex	0	Marketed
Jun 23, 2021	VerkaziaNDA 214965 · New formulation or manufacturer	Harrow Eye	0	Marketed
Feb 2, 2022	CyclosporineANDA 205894	Mylan	0	Marketed
Aug 2, 2022	CyclosporineANDA 216046	Onesource	1	Marketed
Jan 12, 2023	CyclosporineANDA 207606	Apotex	0	Discontinued
May 30, 2023	VevyeNDA 217469 · New formulation or manufacturer	Harrow Eye	2	Marketed
Dec 14, 2023	CyclosporineANDA 203880	Teva Pharms USA Inc	0	Marketed
May 21, 2024	CyclosporineANDA 209811	Deva Holding As	0	Marketed
Jul 5, 2024	CyclosporineANDA 211943	Saptalis Pharms	0	Marketed
Sep 15, 2025	CyclosporineANDA 219049	Qilu	0	Marketed
Nov 28, 2025	CyclosporineANDA 211909	Amneal	0	Discontinued
Jan 21, 2026	CyclosporineANDA 209064	Twi Pharms	0	Marketed
Jun 1, 2026	CyclosporineANDA 219288	Jiangsu Anbison	0	Marketed
Sep 17, 2026	CyclosporineANDA 219652	Aurobindo Pharma Ltd	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA