Cromolyn sodium - Generic Drug Details

What are the generic 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, Viatris Specialty, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Fera Pharms Llc, Hikma, Micro Labs, Roxane, Teva Pharms, 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.

Eleven suppliers are listed for this compound.

Summary for cromolyn sodium

US Patents:	0
Tradenames:	7
Applicants:	27
NDAs:	31
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	23
Patent Applications:	7,129
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
Texas Tech University Health Sciences Center, El Paso	Phase 3
Adli Karadsheh, MD, MS	Phase 3
MedAvante	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
Micro Labs	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	213658-001	Apr 29, 2022	AN	RX	No	No
Hikma	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075333-001	Apr 30, 2002		DISCN	No	No
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Perrigo	CROMOLYN SODIUM	cromolyn sodium	SPRAY, METERED;NASAL	075427-001	Dec 12, 2001		DISCN	No	No
Wockhardt Bio Ag	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075346-001	Oct 25, 1999	AN	RX	No	No
Bausch	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075585-001	Dec 21, 2000		DISCN	No	No

Expired US Patents for cromolyn sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982
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
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
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982