You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Last Updated: November 29, 2023

Minocycline hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for minocycline hydrochloride and what is the scope of freedom to operate?

Minocycline hydrochloride is the generic ingredient in nine branded drugs marketed by Journey, Alvogen, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Rising, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Beximco Pharms Usa, Dr Reddys Labs Ltd, Strides Pharma, and Sun Pharm Industries, and is included in thirty-nine NDAs. There are twenty-five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has seventy-three patent family members in twenty-four countries.

There are fourteen drug master file entries for minocycline hydrochloride. Thirty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	73
US Patents:	25
Tradenames:	9
Applicants:	30
NDAs:	39
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	254
Patent Applications:	4,566
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for minocycline hydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for minocycline hydrochloride
What excipients (inactive ingredients) are in minocycline hydrochloride?	minocycline hydrochloride excipients list
DailyMed Link:	minocycline hydrochloride at DailyMed

See drug prices for minocycline hydrochloride

Recent Clinical Trials for minocycline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Zurich	N/A
Psychiatric University Hospital, Zurich	N/A
Radboud University Medical Center	Phase 2

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 105MG BASE	Tablet, Extended Release; Oral
⤷ Try a Trial	⤷ Try a Trial	EQ 80MG BASE	Tablet, Extended Release; Oral
⤷ Try a Trial	⤷ Try a Trial	EQ 55MG BASE	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for minocycline hydrochloride

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for minocycline hydrochloride

Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZILXI	Topical Aerosol Foam	minocycline hydrochloride	1.50%	213690	1	2022-02-28
AMZEEQ	Topical Aerosol Foam	minocycline hydrochloride	4%	212379	1	2021-05-11
MINOCIN	Injection	minocycline hydrochloride	100 mg/vial	050444	1	2020-10-16
SOLODYN	Extended-release Tablet	minocycline hydrochloride	105 mg	050808	1	2010-12-13
SOLODYN	Extended-release Tablet	minocycline hydrochloride	55 mg	050808	1	2010-12-02
SOLODYN	Extended-release Tablet	minocycline hydrochloride	80 mg	050808	1	2010-10-27
SOLODYN	Extended-release Tablet	minocycline hydrochloride	65 mg and 115 mg	050808	1	2009-11-19

US Patents and Regulatory Information for minocycline hydrochloride

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Sidmak Labs India	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204394-007	Dec 30, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203443-003	Aug 22, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090911-003	Jul 20, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090024-002	Feb 3, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

Expired US Patents for minocycline hydrochloride

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012	⤷ Try a Trial	⤷ Try a Trial
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009	⤷ Try a Trial	⤷ Try a Trial
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010	⤷ Try a Trial	⤷ Try a Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012	⤷ Try a Trial	⤷ Try a Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012	⤷ Try a Trial	⤷ Try a Trial
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for minocycline hydrochloride

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007001961		⤷ Try a Trial
Mexico	347919	COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.)	⤷ Try a Trial
South Africa	201208466	TETRACYCLINE COMPOSITIONS	⤷ Try a Trial
China	102686205	Topical tetracycline compositions	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2010017310		⤷ Try a Trial
Israel	218862		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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

Serving leading biopharmaceutical companies globally:

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.