ELIDEL Drug Patent Profile
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When do Elidel patents expire, and when can generic versions of Elidel launch?
Elidel is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Elidel
A generic version of ELIDEL was approved as pimecrolimus by ACTAVIS LABS UT INC on December 27th, 2018.
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Summary for ELIDEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 39 |
| Patent Applications: | 2,387 |
| Drug Prices: | Drug price information for ELIDEL |
| What excipients (inactive ingredients) are in ELIDEL? | ELIDEL excipients list |
| DailyMed Link: | ELIDEL at DailyMed |
Recent Clinical Trials for ELIDEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St Joseph University, Beirut, Lebanon | Phase 2/Phase 3 |
| Pfizer | Phase 4 |
| Glenmark Pharmaceuticals Ltd. India | Phase 3 |
Pharmacology for ELIDEL
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
US Patents and Regulatory Information for ELIDEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 ELIDEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ELIDEL
See the table below for patents covering ELIDEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 3880634 | ⤷ Sign Up | |
| Denmark | 0427680 | ⤷ Sign Up | |
| Japan | 2007145860 | PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELIDEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0427680 | SPC/GB03/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PIMECROLIMUS OR SALTS OR ESTERS THEREOF; REGISTERED: DK 21034 (MT-NO.32700) 20020315; UK PL 00101/0659 20021003 |
| 0427680 | 300134 | Netherlands | ⤷ Sign Up | 300134, 20101107, EXPIRES: 20151106 |
| 0427680 | SZ 12/2003 | Austria | ⤷ Sign Up | PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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