DrugPatentWatch Database Preview
OTEZLA Drug Profile
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When do Otezla patents expire, and what generic alternatives are available?
This drug has one hundred and two patent family members in twenty-two countries.
The generic ingredient in OTEZLA is apremilast. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.
Summary for OTEZLA
| International Patents: | 102 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 21 |
| Patent Applications: | 72 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | OTEZLA at DailyMed |
Pharmacology for OTEZLA
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Synonyms for OTEZLA
| (+)-N-(2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxo- 2,3-dihydro-1H-isoindol-4-yl)acetamide |
| (S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione(Apremilast) |
| (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide |
| (S)-N-{2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide |
| 608141-41-9 |
| 666854-78-0 |
| AB0093139 |
| AC-27650 |
| Acetamide, N-(2-((1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)- 2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)- |
| AJ-84147 |
| AK151389 |
| AKOS016339660 |
| AOB87775 |
| Apremilast |
| Apremilast (CC-10004) |
| Apremilast (JAN/USAN) |
| Apremilast [USAN:INN] |
| Apremilast/CC 10004/ |
| apremilastum |
| BC600507 |
| BCP0726000109 |
| BCP9000311 |
| BDBM50248919 |
| C22H24N2O7S |
| cas:608141-41-9;Apremilast |
| CC 10004 |
| CC-10004 |
| CC10004 |
| CHEBI:78540 |
| CHEMBL514800 |
| CS-0671 |
| D07ESC |
| D08860 |
| DB05676 |
| EX-A336 |
| FK-0727 |
| FT-0700081 |
| GTPL7372 |
| HE224053 |
| HSDB 8221 |
| HY-12085 |
| IMOZEMNVLZVGJZ-QGZVFWFLSA-N |
| KB-74720 |
| MFCD18782607 |
| MolPort-023-219-158 |
| N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-1,3-dioxoisoindol-4-yl]acetamide |
| N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide |
| N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide |
| Otezla (TN) |
| QCR-202 |
| S-7765 |
| s8034 |
| SC-95443 |
| SCHEMBL302992 |
| UNII-N5UK68MGDZ component IMOZEMNVLZVGJZ-QGZVFWFLSA-N |
| UNII-UP7QBP99PN |
| UP7QBP99PN |
| Y0437 |
| ZINC30691736 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene Corp | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Celgene Corp | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Celgene Corp | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Celgene Corp | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for OTEZLA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
Non-Orange Book US Patents for OTEZLA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,507,759 | Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione | ➤ Sign Up |
| 8,093,283 | Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-1,3-dione, compositions thereof, and uses thereof | ➤ Sign Up |
| 8,629,173 | Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof | ➤ Sign Up |
| 6,011,050 | Substituted phenethylsulfones and method of reducing TNF.alpha. levels | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for OTEZLA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2595375 | ➤ Sign Up |
| Spain | 2608495 | ➤ Sign Up |
| South Korea | 20150126618 | ➤ Sign Up |
| Germany | 69942532 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
