CYCLOSPORINE - Generic Drug Details

What are the generic sources for cyclosporine and what is the scope of patent protection?

Cyclosporine is the generic ingredient in nine branded drugs marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Abbvie, Novartis, Amneal, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Twi Pharms, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in thirty-one NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has three hundred and thirty-three patent family members in thirty-four countries.

There are eighteen drug master file entries for cyclosporine. Twenty-one suppliers are listed for this compound.

Summary for CYCLOSPORINE

International Patents:	333
US Patents:	22
Tradenames:	9
Applicants:	20
NDAs:	31
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,126
Drug Prices:	Drug price trends for CYCLOSPORINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYCLOSPORINE
What excipients (inactive ingredients) are in CYCLOSPORINE?	CYCLOSPORINE excipients list
DailyMed Link:	CYCLOSPORINE at DailyMed

See drug prices for CYCLOSPORINE

Recent Clinical Trials for CYCLOSPORINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor College of Medicine	PHASE4
Harrow Inc	PHASE4
University of Alabama at Birmingham	PHASE4

See all CYCLOSPORINE clinical trials

Pharmacology for CYCLOSPORINE

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for CYCLOSPORINE

Antifungal Agents

Antirheumatic Agents

Calcineurin Inhibitors

Dermatologic Agents

Enzyme Inhibitors

Immunosuppressive Agents

Paragraph IV (Patent) Challenges for CYCLOSPORINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2020-01-29
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2014-01-13

US Patents and Regulatory Information for CYCLOSPORINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995		DISCN	Yes	No
Qilu	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	219049-001	Sep 15, 2025	AB1	RX	No	No
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Abbvie	CYCLOSPORINE	cyclosporine	SOLUTION;ORAL	065025-001	Mar 3, 2000		DISCN	No	No
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Ivax Sub Teva Pharms	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065110-002	Mar 29, 2005	AB1	RX	No	No

Expired US Patents for CYCLOSPORINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995

International Patents for CYCLOSPORINE

Country	Patent Number	Title	Estimated Expiration
Japan	2010168118	DISPENSER
European Patent Office	3356313
China	108349855
South Korea	101507465
Denmark	2512515
Denmark	3083432
Russian Federation	2016125794	ЗАЩИТНЫЙ КОЛПАЧОК ДЛЯ ДИСПЕНСЕРА И ВЫДАЧНОЕ УСТРОЙСТВО ДЛЯ ВЫДАЧИ ЖИДКИХ ЛЕКАРСТВЕННЫХ И/ИЛИ КОСМЕТИЧЕСКИХ СРЕДСТВ В ВИДЕ ЖИДКОСТИ

Supplementary Protection Certificates for CYCLOSPORINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1809237	122015000043	Germany		PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
2049079	PA2017003,C2049079	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
1809237	CA 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
1809237	C01809237/01	Switzerland		PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	CR 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323

Market Dynamics and Financial Trajectory for Cyclosporine

Last updated: February 19, 2026

What is the current market size and revenue for cyclosporine?

Cyclosporine is a calcineurin inhibitor primarily used in transplant rejection prophylaxis and autoimmune diseases. The global market was valued at approximately USD 3.2 billion in 2022, with an expected Compound Annual Growth Rate (CAGR) of 4% from 2023 to 2030. The market's growth is driven by increasing transplant procedures and rising cases of autoimmune disorders, especially in emerging markets.

Revenue breakdown by region (2022)

Region	Revenue (USD billion)	Market Share (%)	Key Drivers
North America	1.5	47	High transplantation rates, patent expiries of branded products
Europe	0.9	28	Growing autoimmune disorder prevalence
Asia-Pacific	0.5	16	Expanding healthcare infrastructure, increasing transplant procedures
Rest of World	0.3	9	Developing healthcare systems

Who are the leading manufacturers and what is their market share?

The top players include Novartis, Sandoz (a Novartis division), and Teva Pharmaceutical Industries. Combined, they account for over 70% of the market.

• Novartis: Supplies Neoral and other formulations, with an estimated 40% market share.
• Sandoz: Offers generics with approximately 20% market share.
• Teva: Provides generic cyclosporine products, holding roughly 12% of the market.

Branded formulations (e.g., Neoral) retain higher pricing support, whereas generics are contributing to price erosion, impacting overall revenue growth.

How are patent expirations influencing the market?

Patent expiration of branded cyclosporine (Neoral) occurred in many regions between 2014 and 2017. This led to a surge in generic competition, which has reduced prices by up to 50% in some markets, pressuring branded drug revenues and prompting companies to diversify portfolios or invest in biosimilars.

What are the key drivers and barriers affecting future growth?

Drivers:

• Higher rates of organ transplantation, driven by advanced surgical techniques and expanding healthcare budgets.
• Increased prevalence of autoimmune diseases such as psoriasis and rheumatoid arthritis.
• Growing acceptance of generic options, lowering drug costs and increasing access.

Barriers:

• Strict regulatory pathways for biosimilars and generics to ensure safety and efficacy.
• Side effect profiles associated with cyclosporine (nephrotoxicity, hypertension), limiting long-term use.
• Competition from newer immunosuppressants like tacrolimus and sirolimus.

How might new formulations and indications impact financial trajectories?

Innovations include sustained-release formulations and combination therapies, potentially expanding market applications. Approvals for new indications such as inflammatory bowel disease could open additional revenue streams. However, R&D costs and uncertain regulatory timelines pose risks to commercialization.

What are the regulatory and policy trends influencing the market?

• The FDA and EMA continue to streamline biosimilar pathways to foster competition.
• Patent litigations and exclusivity periods shape the competitive landscape.
• Pricing policies and reimbursement frameworks in emerging markets influence access and revenue.

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Key Takeaways

• The global cyclosporine market was valued at USD 3.2 billion in 2022, with gradual growth driven by transplant and autoimmune disease trends.
• Patent expiries have led to significant generic penetration, compressing prices.
• Top manufacturers include Novartis, Sandoz, and Teva, controlling over 70% of the market.
• Growth prospects hinge on new formulations, expanded indications, and regulatory environment developments.
• Competitive pressures and safety concerns constrain long-term market expansion.

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5 Frequently Asked Questions

1. How does the patent status affect cyclosporine pricing?
Patent expirations have facilitated generic entry, reducing prices by as much as 50%, pressuring branded revenues and encouraging manufacturers to innovate or diversify.

2. Which regions offer the highest growth potential?
Asia-Pacific and Latin America exhibit higher growth potential due to expanding healthcare infrastructure and increasing access to transplant procedures.

3. Are biosimilars impacting the market?
Yes. Biosimilars are gradually gaining acceptance, especially in Europe, by offering lower-cost alternatives, but regulatory hurdles and safety concerns slow their adoption.

4. What are the primary side effects influencing long-term use?
Nephrotoxicity and hypertension are the main adverse effects, limiting long-term use and prompting development of alternative immunosuppressants.

5. What future innovations could alter the market trajectory?
Sustained-release formulations, combination therapies, and new indications like inflammatory bowel disease can expand applications and revenue, contingent on successful R&D and regulatory approval.

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References

1. MarketResearch.com. (2023). Global Cyclosporine Market Analysis.
2. Grand View Research. (2022). Cyclosporine Market Size, Share & Trends.
3. FDA. (2021). Guidance for Industry: Biosimilar Product Development.
4. Pfizer. (2020). Patent Expiry and Its Effects on the Immunosuppressant Market.
5. European Medicines Agency. (2022). Biosimilar Medicines in the EU.