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

See drug prices for PIMECROLIMUS

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

See all PIMECROLIMUS clinical trials

Pharmacology for PIMECROLIMUS

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PIMECROLIMUS

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for PIMECROLIMUS

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Glossary

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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

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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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