KARBINAL ER Drug Patent Profile
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When do Karbinal Er patents expire, and what generic alternatives are available?
Karbinal Er is a drug marketed by Aytu and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Karbinal Er
A generic version of KARBINAL ER was approved as carbinoxamine maleate by MIKART on March 19th, 2003.
Summary for KARBINAL ER
International Patents: | 21 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Patent Applications: | 1,373 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KARBINAL ER |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KARBINAL ER |
DailyMed Link: | KARBINAL ER at DailyMed |


See drug prices for KARBINAL ER

Pharmacology for KARBINAL ER
Drug Class | Histamine-1 Receptor Antagonist |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for KARBINAL ER
US Patents and Regulatory Information for KARBINAL ER
KARBINAL ER is protected by two US patents.
Patents protecting KARBINAL ER
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug--ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aytu | KARBINAL ER | carbinoxamine maleate | SUSPENSION, EXTENDED RELEASE;ORAL | 022556-001 | Mar 28, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Aytu | KARBINAL ER | carbinoxamine maleate | SUSPENSION, EXTENDED RELEASE;ORAL | 022556-001 | Mar 28, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KARBINAL ER
See the table below for patents covering KARBINAL ER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2428205 | Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes) | ⤷ Try a Trial |
Spain | 2378573 | ⤷ Try a Trial | |
South Korea | 20080108520 | MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |