Diltiazem hydrochloride - Generic Drug Details
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What are the generic sources for diltiazem hydrochloride and what is the scope of freedom to operate?
Diltiazem hydrochloride
is the generic ingredient in twelve branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Exela Pharma, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for diltiazem hydrochloride. Fifty-three suppliers are listed for this compound.
Summary for diltiazem hydrochloride
| US Patents: | 0 |
| Tradenames: | 12 |
| Applicants: | 39 |
| NDAs: | 62 |
| Drug Master File Entries: | 17 |
| Finished Product Suppliers / Packagers: | 53 |
| Raw Ingredient (Bulk) Api Vendors: | 131 |
| Clinical Trials: | 106 |
| Patent Applications: | 4,517 |
| 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 |
| Hospices Civils de Lyon | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-001 | Sep 11, 1995 | AB4 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-004 | Feb 6, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apothecon | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 074051-002 | Mar 31, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Edenbridge Pharms | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 211596-004 | Nov 18, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 216521-003 | Sep 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Fl Inc | CARTIA XT | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074752-002 | Jul 9, 1998 | AB3 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203023-001 | Jun 8, 2017 | AB3 | RX | 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 |
|---|---|---|---|---|---|---|---|
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-004 | Sep 11, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-001 | Jan 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-003 | Sep 11, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-003 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-005 | Feb 6, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-003 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-002 | Sep 11, 1995 | ⤷ 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.
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DrugPatentWatch Alternatives
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