CROMOLYN SODIUM - Generic Drug Details

What are the generic drug sources for cromolyn sodium and what is the scope of patent protection?

Cromolyn sodium is the generic ingredient in seven branded drugs marketed by King Pharms Llc, Sanofi Aventis Us, Ucb Inc, Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Mylan Speciality Lp, Bausch And Lomb, Akorn, Apotex Inc, Sandoz, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Hh And P, Perrigo, and Blacksmith Brands, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cromolyn sodium. Seventeen suppliers are listed for this compound.

Summary for CROMOLYN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	27
NDAs:	31
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	23
Patent Applications:	6,462
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CROMOLYN SODIUM?	CROMOLYN SODIUM excipients list
DailyMed Link:	CROMOLYN SODIUM at DailyMed

Recent Clinical Trials for CROMOLYN SODIUM

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

Sponsor	Phase
Adli Karadsheh, MD, MS	Phase 3
Texas Tech University Health Sciences Center, El Paso	Phase 3
APCER	Phase 2

See all CROMOLYN SODIUM clinical trials

Pharmacology for CROMOLYN SODIUM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM

Anti-Asthmatic Agents

US Patents and Regulatory Information for CROMOLYN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	GASTROCROM	cromolyn sodium	CAPSULE;ORAL	019188-001	Dec 22, 1989		DISCN	No	No
Genera Pharms	CROMOLYN SODIUM	cromolyn sodium	CONCENTRATE;ORAL	090954-001	Dec 18, 2009		DISCN	No	No
Actavis Mid Atlantic	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075067-001	Jul 19, 1999		DISCN	No	No
Hh And P	CROMOLYN SODIUM	cromolyn sodium	SPRAY, METERED;NASAL	077976-001	Sep 7, 2007		DISCN	No	No
Roxane	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075175-001	Sep 30, 1999		DISCN	No	No
Blacksmith Brands	NASALCROM	cromolyn sodium	SPRAY, METERED;NASAL	020463-001	Jan 3, 1997		DISCN	Yes	No
Wockhardt Bio Ag	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075346-001	Oct 25, 1999	AN	RX	No	No

Expired US Patents for CROMOLYN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982