Caffeine citrate - Generic Drug Details

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What are the generic drug sources for caffeine citrate and what is the scope of patent protection?

Caffeine citrate is the generic ingredient in two branded drugs marketed by Hikma, Am Regent, Eugia Pharma, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for caffeine citrate

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	14
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	31
Patent Applications:	534
Drug Prices:	Drug price trends for caffeine citrate
What excipients (inactive ingredients) are in caffeine citrate?	caffeine citrate excipients list
DailyMed Link:	caffeine citrate at DailyMed

See drug prices for caffeine citrate

Recent Clinical Trials for caffeine citrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Al-Azhar University	Early Phase 1
Amgen	Early Phase 1
National Institute on Aging (NIA)	Phase 2

See all caffeine citrate clinical trials

Pharmacology for caffeine citrate

Drug Class	Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for caffeine citrate

Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for caffeine citrate

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for caffeine citrate

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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
Sagent Pharms	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	091102-001	Aug 29, 2012	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CAFCIT	caffeine citrate	SOLUTION;ORAL	020793-002	Apr 12, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Exela Pharma	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	077304-001	Sep 21, 2006	AA	RX	No	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

EU/EMA Drug Approvals for caffeine citrate

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gennisium Pharma	Gencebok	caffeine citrate	EMEA/H/C/005435 Treatment of primary apnoea of premature newborns.	Authorised	no	no	no	2020-08-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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