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OTEZLA Drug Profile
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» See Plans and PricingWhen do Otezla patents expire, and when can generic versions of Otezla launch?
Otezla is a drug marketed by Amgen Inc and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-nine patent family members in twenty-three countries.
The generic ingredient in OTEZLA is apremilast. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apremilast profile page.
US ANDA Litigation and Generic Entry Outlook for Otezla
Otezla was eligible for patent challenges on March 21, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 16, 2028. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases 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 four tentative approvals for the generic drug (apremilast), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for OTEZLA
| International Patents: | 89 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 34 |
| Patent Applications: | 90 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OTEZLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTEZLA |
| DailyMed Link: | OTEZLA at DailyMed |
Generic Entry Opportunity Date for OTEZLA
Generic Entry Date for OTEZLA*:
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 OTEZLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tufts Medical Center | Phase 2 |
| Amgen | Phase 2 |
| Dermatology Department University Hospital Frankfurt | Phase 2 |
Pharmacology for OTEZLA
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for OTEZLA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OTEZLA | TABLET;ORAL | apremilast | 205437 | 2018-03-22 |
US Patents and Regulatory Information for OTEZLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OTEZLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | Start Trial | Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | Start Trial | Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OTEZLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2223688 | Start Trial |
| South Korea | 101104991 | Start Trial |
| Cyprus | 1114304 | Start Trial |
| Cyprus | 1119204 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OTEZLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | CA 2019 00033 | Denmark | Start Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | 132019000000096 | Italy | Start Trial | PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116 |
| 2962690 | 2019/037 | Ireland | Start Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| 2962690 | C20190029 00295 | Estonia | Start Trial | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
