Viewing data from:

RESTASIS

NDA

CYCLOSPORINE | N050790 | ABBVIE INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents (4 delisted) by expiration date

Active (4)TodayDelisted

4 patents delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2027

2028

2029

2030

2031

2032

2033

2034

Today

8292129

Feb. 25, 2031Delisted

8561859

Apr. 16, 2032Delisted

9669974

May. 11, 2034Delisted

9676525

Feb. 7, 2034Delisted

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Physical Pharmaceutica, LLC FDA-2015-P-1404 Physical Pharmaceutica LLC filed this citizen petition in April 2015 regarding the approval of Abbreviated New Drug Applications (ANDAs) referencing RESTASIS 0.05% ophthalmic emulsion as the reference listed drug. Physical Pharmaceutica requests that the FDA provide detailed guidance on what compara	505(q)	2015-04-30	Denied	Physical Pharmaceutica

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Restasis (2023)

Total Spending

$1.5B

Total Claims

1,431,080

Beneficiaries

492,479

Avg Cost/Unit

$11.33

Spending Trend

$1.4B(2019)→$1.5B(2020)→$1.6B(2021)→$1.6B(2022)→$1.5B(2023)

YoY Change:+2.3%

5yr CAGR:+4.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs5 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVCYCLOSPORINE

DMF 129321998

CURIA ITALY SRLCYCLOSPORINE

DMF 129491998

FUJIAN KERUI PHARMACEUTICAL CO LTDCYCLOSPORINE

DMF 137891998

TAPI NL BVCYCLOSPORINE

DMF 137991998

ABBVIE INCCYCLOSPORINE USP

DMF 138001998

APOTEX INCCYCLOSPORINE USP (BULK)

DMF 139291999

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDCYCLOSPORINE (NON-STERILE BULK FORM)

DMF 189322005

CONCORD BIOTECH LTDCYCLOSPORINE USP

DMF 239622010

ZHEJIANG RUIBANG LABORATORIESCYCLOSPORINE

DMF 285122014

TAPI NL BVCYCLOSPORINE ID: 741710

DMF 295572015

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDCYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 339462019

TAPI NL BVCYCLOSPORINE ID: 741310

DMF 346422020

CURIA ITALY SRLCYCLOSPORINE 350507

DMF 363852021

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)CYCLOSPORINE USP

DMF 429662025

SANDOZ PHARMA LTDInactiveCYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

DMF 116181995

GALENA ASInactiveCYCLOSPORINE

DMF 119711996

ZHEJIANG RUIBANG LABORATORIES INCInactiveCYCLOSPORINE

DMF 138581998

WATSON LABORATORIES INCInactiveCYCLOSPORINE

DMF 153282001

ZHEJIANG RUIBANG LABORATORIESInactiveCYCLOSPORINE CRUDE

DMF 314652018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2025	SUPPL -31	View Letter (PDF)
Jul 21, 2017	SUPPL -27	View Letter (PDF)
Dec 5, 2012	SUPPL -20	View Letter (PDF)
Oct 1, 2003	SUPPL -3	View Letter (PDF)
Oct 1, 2003	SUPPL -4	View Letter (PDF)
Sep 25, 2003	SUPPL -1	View Letter (PDF)
Sep 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

EMULSION;OPHTHALMIC | Approved: Dec 23, 2002

No patent or exclusivity listings for this strength.

#002 — 0.05%

RLD

4 patents0 exclusivities▾

EMULSION;OPHTHALMIC | Approved: Oct 27, 2016