Last Updated: September 24, 2026

CROMOLYN SODIUM - Generic Drug Details

Name: CROMOLYN SODIUM Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

✉ Email this page to a colleague

« Back to Dashboard

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, 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
Pharma Consulting Group (PCG)	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	CROMOLYN SODIUM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	075615-001	Jan 26, 2001		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Blacksmith Brands	NASALCROM	cromolyn sodium	SPRAY, METERED;NASAL	020463-001	Jan 3, 1997		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	AA	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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 CROMOLYN SODIUM

Subscribe to access the full database, or Start Trial
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	⤷ Start Trial	⤷ Start Trial
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	⤷ Start Trial	⤷ Start Trial
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.