DILTIAZEM HYDROCHLORIDE Drug Patent Profile
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Which patents cover Diltiazem Hydrochloride, and what generic alternatives are available?
Diltiazem Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Amta, Apotex, Biovail, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, and Exela Pharma. and is included in fifty NDAs.
The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diltiazem Hydrochloride
A generic version of DILTIAZEM HYDROCHLORIDE was approved as diltiazem hydrochloride by TEVA on May 31st, 1995.
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Summary for DILTIAZEM HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 35 |
| NDAs: | 50 |
| Finished Product Suppliers / Packagers: | 46 |
| Raw Ingredient (Bulk) Api Vendors: | 131 |
| Clinical Trials: | 106 |
| Patent Applications: | 2,870 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DILTIAZEM HYDROCHLORIDE |
| What excipients (inactive ingredients) are in DILTIAZEM HYDROCHLORIDE? | DILTIAZEM HYDROCHLORIDE excipients list |
| DailyMed Link: | DILTIAZEM HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ascension Genesys Hospital | Phase 2 |
| Aurora Health Care | Phase 4 |
| Signia Therapeutics | Phase 2 |
Pharmacology for DILTIAZEM HYDROCHLORIDE
| Drug Class | Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DILTIAZEM HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CARDIZEM LA | Extended-release Tablets | diltiazem hydrochloride | 120 mg, 180 mg, 240 mg, 300 mg and 360 mg | 021392 | 1 | 2005-08-30 |
| CARDIZEM LA | Extended-release Tablets | diltiazem hydrochloride | 420 mg | 021392 | 1 | 2005-04-25 |
US Patents and Regulatory Information for DILTIAZEM HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074079-001 | Nov 30, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Farmaceutica | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 202651-001 | Aug 9, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nesher Pharms | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 076563-006 | Sep 12, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glenmark Pharms Ltd | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212317-002 | Mar 22, 2021 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 074067-001 | Nov 5, 1992 | 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 DILTIAZEM HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-002 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-001 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-004 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-002 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-003 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DILTIAZEM HYDROCHLORIDE
See the table below for patents covering DILTIAZEM HYDROCHLORIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69229949 | ⤷ Sign Up | |
| Denmark | 0591424 | ⤷ Sign Up | |
| European Patent Office | 0591424 | DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM) | ⤷ Sign Up |
| Australia | 2243092 | ⤷ Sign Up | |
| Austria | 184196 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated 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.
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