KALYDECO Drug Patent Profile
✉ Email this page to a colleague
When do Kalydeco patents expire, and what generic alternatives are available?
Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and fifty-eight patent family members in thirty-four countries.
The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
DrugPatentWatch® Generic Entry Outlook for Kalydeco
Kalydeco was eligible for patent challenges on January 31, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 13, 2029. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (ivacaftor), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KALYDECO?
- What are the global sales for KALYDECO?
- What is Average Wholesale Price for KALYDECO?
Summary for KALYDECO
International Patents: | 258 |
US Patents: | 13 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 26 |
Patent Applications: | 831 |
Drug Prices: | Drug price information for KALYDECO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KALYDECO |
What excipients (inactive ingredients) are in KALYDECO? | KALYDECO excipients list |
DailyMed Link: | KALYDECO at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KALYDECO
Generic Entry Dates for KALYDECO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL |
Generic Entry Dates for KALYDECO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for KALYDECO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
University of Kansas Medical Center | Early Phase 1 |
University of North Carolina | Early Phase 1 |
Pharmacology for KALYDECO
US Patents and Regulatory Information for KALYDECO
KALYDECO is protected by thirty-two US patents and seven FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KALYDECO is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925-001 | Mar 17, 2015 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925-002 | Mar 17, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925-003 | Apr 29, 2019 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for KALYDECO
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Vertex Pharmaceuticals (Ireland) Limited | Kalydeco | ivacaftor | EMEA/H/C/002494 Kalydeco tablets are indicated:As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene (see section 5.1).Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1). |
Authorised | no | no | no | 2012-07-23 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for KALYDECO
When does loss-of-exclusivity occur for KALYDECO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09282419
Estimated Expiration: ⤷ Try for Free
Patent: 10282986
Estimated Expiration: ⤷ Try for Free
Patent: 13226076
Patent: Pharmaceutical composition and administration thereof
Estimated Expiration: ⤷ Try for Free
Patent: 16216569
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2014021090
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 65519
Estimated Expiration: ⤷ Try for Free
China
Patent: 4470518
Estimated Expiration: ⤷ Try for Free
Patent: 9966264
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 19670
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 03840
Estimated Expiration: ⤷ Try for Free
Patent: 05690
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 4307
Estimated Expiration: ⤷ Try for Free
Patent: 5430
Estimated Expiration: ⤷ Try for Free
Patent: 1180
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 34041
Estimated Expiration: ⤷ Try for Free
Patent: 15511583
Estimated Expiration: ⤷ Try for Free
Patent: 17190356
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 14010253
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 9199
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 92779
Estimated Expiration: ⤷ Try for Free
Patent: 14139006
Estimated Expiration: ⤷ Try for Free
Patent: 19116577
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1406233
Patent: PHARMACEUTICAL COMPOSITION AND ADMINISTRATION THEREOF
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KALYDECO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Croatia | P20180300 | ⤷ Try for Free | |
Russian Federation | 2382779 | МОДУЛЯТОРЫ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ (ATP-BINDING CASETTE TRANSPORTER MODULATORS) | ⤷ Try for Free |
Japan | 2014156468 | MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KALYDECO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1773816 | CR 2015 00038 | Denmark | ⤷ Try for Free | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | 15C0045 | France | ⤷ Try for Free | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | CA 2015 00038 | Denmark | ⤷ Try for Free | PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of KALYDECO
More… ↓