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Last Updated: December 2, 2024

Cromolyn sodium - Generic Drug Details


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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, Mylan Speciality Lp, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms Inc, 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. Eighteen 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: 18
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 23
Patent Applications: 8,076
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

SponsorPhase
Texas Tech University Health Sciences Center, El PasoPhase 3
Adli Karadsheh, MD, MSPhase 3
MedAvantePhase 2

See all cromolyn sodium clinical trials

Pharmacology for cromolyn sodium
Drug ClassMast Cell Stabilizer
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for cromolyn sodium

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
Bausch And Lomb CROMOLYN SODIUM cromolyn sodium SPRAY, METERED;NASAL 075702-001 Jul 3, 2001 OTC No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genera Pharms CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 090954-001 Dec 18, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blacksmith Brands NASALCROM cromolyn sodium SPRAY, METERED;NASAL 020463-001 Jan 3, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075585-001 Dec 21, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Mid Atlantic CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075067-001 Jul 19, 1999 DISCN No No ⤷  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 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 ⤷  Sign Up ⤷  Sign Up
Ucb Inc GASTROCROM cromolyn sodium CAPSULE;ORAL 019188-001 Dec 22, 1989 ⤷  Sign Up ⤷  Sign Up
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium AEROSOL, METERED;INHALATION 018887-001 Dec 5, 1985 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us INTAL cromolyn sodium CAPSULE;INHALATION 016990-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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. 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.