Product profile · United States

DORYX MPC

· Patent Litigation & Settlement History ↓

IngredientDOXYCYCLINE HYCLATE

Application typeNDA

Application050795

Product007

Dosage formTABLET, DELAYED RELEASE

RouteORAL

StrengthEQ 60MG BASE

Approval date2016-05-20

Marketing statusPrescription

Status event—

ApplicantMAYNE PHARMA

Product source

Current GenericRadar decision

Year2023

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2023-08-11

Patent anchor—

Exclusivity anchor—

Protection date2034-12-23

First Final ANDA2023-08-11

Status event—

Exclude 2018-03-27 for 090134/S018: tentative approval of new 60/120 mg strengths. Separately verified Lupin 208741 approval on 2023-08-11 and the manufacturer's DORYX MPC 60 mg reference announcement. Current marketing status and historical Final approval are separate facts. Existing candidate details require comparison to establish the earliest approval.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8715724	2028-02-03	DP —	N	N	FORMULATION_OR_PK	—	—	—
8715724	2028-02-03	DP —	N	N	FORMULATION_OR_PK Limited to a doxycycline dry-powder antistatic coating and compressed-pellet manufacturing process.	—	—	—
9295652	2034-10-23	DP/U U-918	N	N	FORMULATION_OR_PK	—	—	—
9295652	2034-10-23	DP/U U-918	N	N	FORMULATION_OR_PK Limited to doxycycline 60/90/120 mg controlled-release pellets, pH-dependent dissolution, and Cmax/AUC.	—	—	—
9511031	2034-10-23	DP —	N	N	FORMULATION_OR_PK	—	—	—
9511031	2034-10-23	DP —	N	N	FORMULATION_OR_PK Limited to doxycycline 60/90/120 mg controlled release, dissolution at pH 5, and Cmax/AUC.	—	—	—
9446057	2034-12-23	DP/U U-918	N	N	FORMULATION_OR_PK	—	—	—
9446057	2034-12-23	DP/U U-918	N	N	FORMULATION_OR_PK Limited to doxycycline modified-release pellets/polymer, dose, and effective concentration at pH 5.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
208741 / 002	FINAL_APPROVAL · FINAL_APPROVED	2023-08-11	—	LUPIN INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
208741 / 002	FINAL_APPROVAL · FINAL_APPROVED	2023-08-11	—	LUPIN INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
208741 / 002	FINAL_APPROVAL · FINAL_APPROVAL	2023-08-11	—	LUPIN INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
208741 / 002	FINAL_APPROVAL · FINAL_APPROVAL	2023-08-11	—	LUPIN INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 4 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
208741 / 002	LUPIN INC	FINAL_APPROVAL · FINAL_APPROVED	2023-08-11	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
208741 / 002	LUPIN INC	FINAL_APPROVAL · FINAL_APPROVED	2023-08-11	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
208741 / 002	LUPIN INC	FINAL_APPROVAL · FINAL_APPROVAL	2023-08-11	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
208741 / 002	LUPIN INC	FINAL_APPROVAL · FINAL_APPROVAL	2023-08-11	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—

Decision evidence (5)

Type	Date	Role	Basis	Source
GENERIC_APPROVAL	2023-08-11	DISQUALIFYING_FINAL_GENERIC	Exact Final ANDA208741/002 -> NDA050795/007	Source
PATENT	2028-02-03	FTO_TAIL	Limited to a doxycycline dry-powder antistatic coating and compressed-pellet manufacturing process.	Source
PATENT	2034-10-23	FTO_TAIL	Limited to doxycycline 60/90/120 mg controlled-release pellets, pH-dependent dissolution, and Cmax/AUC.	Source
PATENT	2034-10-23	FTO_TAIL	Limited to doxycycline 60/90/120 mg controlled release, dissolution at pH 5, and Cmax/AUC.	Source
PATENT	2034-12-23	FTO_TAIL	Limited to doxycycline modified-release pellets/polymer, dose, and effective concentration at pH 5.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.