Pimecrolimus - Generic Drug Details
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What are the generic drug sources for pimecrolimus and what is the scope of freedom to operate?
Pimecrolimus
is the generic ingredient in two branded drugs marketed by Bausch, Actavis Labs Ut Inc, and Glenmark Pharms Ltd, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for pimecrolimus. Five suppliers are listed for this compound.
Summary for pimecrolimus
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 59 |
Patent Applications: | 7,049 |
Drug Prices: | Drug price trends for pimecrolimus |
What excipients (inactive ingredients) are in pimecrolimus? | pimecrolimus excipients list |
DailyMed Link: | pimecrolimus at DailyMed |
Recent Clinical Trials for pimecrolimus
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Hepatology & Tropical Medicine Research Institute | Phase 4 |
Combined Military Hospital Abbottabad | Phase 1 |
Postgraduate Institute of Dental Sciences Rohtak | Phase 4 |
Pharmacology for pimecrolimus
Drug Class | Calcineurin Inhibitor Immunosuppressant |
Mechanism of Action | Calcineurin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for pimecrolimus
US Patents and Regulatory Information for pimecrolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Labs Ut Inc | PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 209345-001 | Dec 27, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Pharms Ltd | PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 211769-001 | Aug 29, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
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 pimecrolimus
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 |
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