SUMYCIN Drug Patent Profile

When do Sumycin patents expire, and what generic alternatives are available?

Sumycin is a drug marketed by Apothecon, Ph Health, and Strides Pharma Intl. and is included in three NDAs.

The generic ingredient in SUMYCIN is tetracycline hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sumycin

A generic version of SUMYCIN was approved as tetracycline hydrochloride by WATSON LABS on December 31^st, 1969.

Summary for SUMYCIN

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Patent Applications:	6,933
DailyMed Link:	SUMYCIN at DailyMed

Pharmacology for SUMYCIN

Drug Class

Tetracycline-class Antimicrobial

US Patents and Regulatory Information for SUMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	SUMYCIN	tetracycline hydrochloride	CAPSULE;ORAL	060429-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Strides Pharma Intl	SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	SUMYCIN	tetracycline hydrochloride	CAPSULE;ORAL	060429-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Strides Pharma Intl	SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147-001	Approved Prior to Jan 1, 1982		RX	No	No
Apothecon	SUMYCIN	tetracycline hydrochloride	CAPSULE;ORAL	060429-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	SUMYCIN	tetracycline hydrochloride	CAPSULE;ORAL	060429-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Sumycin Market Dynamics, Financial Trajectory, Patent Status, and Generic Competition

Last updated: September 14, 2026

Sumycin is the former Bristol-Myers Squibb brand for tetracycline hydrochloride, an oral broad-spectrum antibiotic. Its commercial trajectory is complete brand erosion: the product lost meaningful exclusivity decades ago, generic tetracycline became the economic standard, and Sumycin no longer has a material standalone revenue base. Current market value resides in generic tetracycline hydrochloride, not in the Sumycin trademark.

What is Sumycin and who marketed it?

Sumycin was an oral tetracycline hydrochloride product marketed primarily in 250-mg and 500-mg capsules or tablets. Bristol-Myers Squibb and predecessor entities were associated with the brand and its U.S. commercialization.

Attribute	Sumycin
Active ingredient	Tetracycline hydrochloride
Drug class	Tetracycline antibiotic
Historical brand owner	Bristol-Myers Squibb and predecessors
Primary dosage forms	Oral capsules and tablets
Historical strengths	Commonly 250 mg and 500 mg
U.S. regulatory status	No meaningful current branded market presence
Current commercial substitute	Generic tetracycline hydrochloride
Biologic status	Not applicable
Biosimilar exposure	None
Current Orange Book value	No material active brand patent position identified

Tetracycline was introduced in the 1950s and became a widely used treatment for bacterial infections. The molecule subsequently faced competition from doxycycline and minocycline, which generally offered more convenient dosing and improved pharmacokinetic profiles.

When did Sumycin lose exclusivity?

Sumycin lost practical exclusivity after the expiration of the early tetracycline patent and regulatory exclusivity framework. The brand has been exposed to generic competition for many years, and no current market exclusivity protects the product.

The commercial erosion followed a familiar sequence:

1. Original composition and manufacturing protection expired.
2. Generic tetracycline products entered the market.
3. Prescribing shifted toward doxycycline and minocycline in several indications.
4. Institutional buyers substituted lower-cost generic products.
5. The Sumycin brand became commercially marginal and was ultimately discontinued or no longer actively marketed.

The original patent estate is not economically relevant to current competition. The FDA Orange Book does not identify a live, commercially meaningful Sumycin patent position that would delay generic entry or support a new exclusivity period (FDA, 2024a).

What is the FDA regulatory status of Sumycin?

Public FDA and National Library of Medicine records indicate that Sumycin is not an actively marketed branded product in the U.S. The product should be analyzed as a discontinued brand rather than as an active branded prescription asset.

FDA discontinued-product records generally distinguish a marketing discontinuation from a withdrawal based on safety or efficacy. Sumycin’s commercial decline is consistent with loss of economic viability and substitution by generic tetracycline and newer tetracycline-class antibiotics, rather than a current branded regulatory exclusivity event.

The active ingredient remains an FDA-recognized prescription antibiotic. Generic tetracycline hydrochloride products continue to be listed in U.S. drug databases, subject to manufacturer availability and supply conditions (FDA, 2024b; National Library of Medicine, 2024).

What patents protect Sumycin?

No current patent estate appears to protect the Sumycin brand, tetracycline hydrochloride as an old active ingredient, or ordinary oral Sumycin dosage forms.

Patent category	Current position
Composition-of-matter patent	Expired
Brand-specific patent	No material active protection identified
Oral capsule or tablet formulation patent	No current commercially significant protection identified
Method-of-use patent	No current Sumycin-specific exclusivity identified
Manufacturing patent	Any relevant early protection would be expired or commercially nonblocking
Orange Book-listed patent	No material active listing identified
Regulatory exclusivity	Expired

The lack of active patents does not eliminate operational barriers. Generic manufacturers must still comply with current good manufacturing practice requirements, establish bioequivalence, maintain an approved abbreviated new drug application, and secure reliable active pharmaceutical ingredient supply.

How strong is the Sumycin patent estate?

The Sumycin patent estate is commercially weak and should be assigned no meaningful ability to prevent generic competition.

The relevant distinction is between historical intellectual property and enforceable present-day exclusivity. Tetracycline’s original chemistry and core manufacturing know-how were developed many decades ago. Those rights do not create a modern barrier to entry. Any remaining protection would need to cover a specific active formulation, delivery system, indication, or manufacturing process. No such Sumycin-specific protection is apparent in the current FDA patent framework.

For diligence purposes, Sumycin should be classified as:

• Patent expiry risk: negligible.
• Paragraph IV risk: historical or irrelevant.
• Formulation patent risk: low.
• Method-of-use risk: low.
• Trade-secret manufacturing risk: potentially relevant only at the supplier level.
• Trademark risk: low for generic substitution, but brand use remains subject to trademark controls.

Were there Paragraph IV challenges to Sumycin?

Paragraph IV litigation is not a current commercial issue for Sumycin. The product’s generic competition is mature, and any original generic entry disputes would have occurred many years ago.

A Paragraph IV certification permits an abbreviated new drug application applicant to assert that a listed patent is invalid, unenforceable, or would not be infringed. That mechanism has little present relevance where:

• The relevant composition patents have expired.
• No active Sumycin Orange Book patent creates a meaningful launch barrier.
• Generic tetracycline products are already available.
• The branded product has no current commercial franchise to defend.

No active, material Sumycin Paragraph IV litigation has been identified in current public FDA and federal court records.

What formulation patents protect Sumycin?

No commercially material formulation patent currently protects the conventional Sumycin oral capsule or tablet.

The historic product used a conventional immediate-release tetracycline hydrochloride dosage form. It did not establish a durable extended-release, controlled-release, depot, implantable, or specialty-delivery franchise. This left the brand vulnerable to direct generic substitution.

A future company could seek protection for a reformulated tetracycline product, such as:

• Modified-release oral delivery.
• Combination therapy.
• Pediatric-friendly liquid formulation.
• Gastrointestinal-tolerability formulation.
• Targeted antimicrobial delivery.
• New fixed-dose combinations.

Those products would be new commercial assets, not continuing Sumycin exclusivity. They would require separate regulatory and patent analysis.

How did doxycycline and minocycline affect Sumycin?

Doxycycline and minocycline reduced the addressable market for tetracycline hydrochloride by offering clinical and dosing advantages in several use cases.

Factor	Sumycin, tetracycline	Doxycycline	Minocycline
Typical dosing convenience	Less convenient	Generally more convenient	Generally more convenient
Food and mineral interaction burden	Significant	Present but often more manageable	Present
Common dermatology use	Legacy role	Strong	Strong
Generic availability	Yes	Yes	Yes
Brand premium potential	Minimal	Historically higher, now largely eroded	Historically higher, now largely eroded
Current market position	Mature generic	Mature generic	Mature generic

Doxycycline became a major substitute in respiratory, dermatological, sexually transmitted, tick-borne, and other infectious disease indications. Minocycline retained a strong position in acne and selected dermatology uses. These alternatives compressed both Sumycin prescribing volume and the ability to sustain a premium brand price.

What was Sumycin’s financial trajectory?

No reliable public source reports standalone Sumycin revenue for the modern period. Bristol-Myers Squibb’s public filings report company and business-segment results, not a separate revenue line for a legacy product such as Sumycin (Bristol-Myers Squibb, 2000; Bristol-Myers Squibb, 2024).

The financial trajectory can therefore be characterized directionally:

Period	Commercial condition	Financial effect
Initial launch and growth	Branded tetracycline with limited direct competition	High relative pricing power
Mature brand period	Broad use in primary care and infectious disease	Meaningful historical brand revenue
Generic entry	Direct substitution by lower-cost tetracycline	Sharp price and volume erosion
Later lifecycle	Competition from doxycycline and minocycline	Continued decline in prescriptions
Discontinuation period	Limited branded distribution	De minimis or zero direct brand revenue
Current period	Generic-only market	No material Sumycin revenue stream

Sumycin’s revenue did not likely disappear because of one patent cliff alone. The decline was cumulative. Generic entry reduced price, therapeutic substitution reduced volume, and the absence of a differentiated formulation limited the brand’s ability to defend share.

What is the current market for generic tetracycline?

The current market is a mature, low-price generic market with intermittent supply and procurement considerations. Generic tetracycline hydrochloride is used where clinicians specifically select tetracycline rather than a newer class member.

Demand is influenced by:

• Resistance patterns.
• Clinical guidelines.
• Availability of doxycycline and minocycline.
• Hospital and pharmacy purchasing contracts.
• Manufacturer participation.
• Active pharmaceutical ingredient supply.
• Shortages affecting older antibiotics.
• Patient-specific contraindications and tolerability.

Older antibiotics can retain episodic value when newer products are unavailable, contraindicated, or clinically unsuitable. That does not restore brand economics. It creates volume and supply opportunities for generic manufacturers, contract manufacturers, and distributors.

What generic entry risks exist for Sumycin?

Generic entry is no longer a future risk. It is the established market structure.

A hypothetical relaunch of Sumycin would face:

• Immediate therapeutic substitution.
• Limited physician loyalty to the discontinued brand.
• Low reimbursement support for a branded tetracycline.
• Established generic approvals.
• Weak or nonexistent patent protection.
• Competition from doxycycline and minocycline.
• Pharmacy benefit manager resistance to premium pricing.
• Limited justification for brand-only prescribing.

A relaunch would require a clear differentiator, such as a new dosage form, a clinically meaningful tolerability advantage, a pediatric indication, or a supply-reliability proposition. The historical Sumycin formulation alone would not support a defensible premium.

What manufacturing and intellectual-property barriers remain?

The primary barriers are regulatory and operational, not patent-based.

Active pharmaceutical ingredient supply

Tetracycline hydrochloride requires compliant API production, impurity control, validated analytical methods, and reliable sourcing. A manufacturer with limited scale may face higher costs than competitors despite low nominal formulation complexity.

Stability and packaging

Oral tetracycline products require appropriate stability controls and packaging. Product degradation and impurity formation must be controlled through manufacturing, storage, and distribution.

Regulatory compliance

A generic sponsor must maintain:

• An approved ANDA.
• Current good manufacturing practice compliance.
• Bioequivalence support.
• Quality-system controls.
• Pharmacovigilance and labeling compliance.
• Reliable commercial-scale supply.

Process know-how

Process know-how may produce cost or quality advantages, but it is not equivalent to an enforceable patent barrier. Any trade-secret advantage would protect a manufacturer’s process privately and would not block other approved manufacturers from selling generic tetracycline.

Are there licensing deals or active litigation involving Sumycin?

No major current licensing transaction involving Sumycin has been identified in public corporate disclosures. The brand’s commercial status does not support a visible modern licensing market.

No material active patent litigation involving Sumycin has been identified in the current public record. Any litigation risk is more likely to arise from:

• Generic manufacturing quality.
• Product liability.
• Antitrust or distribution conduct.
• Trademark use.
• Supply agreements.
• Regulatory enforcement.

Those issues are distinct from a branded patent dispute and should not be treated as evidence of an active Sumycin exclusivity position.

What is the commercial outlook for Sumycin?

The commercial outlook for Sumycin as a branded drug is negligible. The active commercial opportunity lies in generic tetracycline hydrochloride, supply-chain participation, or development of differentiated tetracycline products.

Base case

Generic tetracycline remains available at low prices, with demand concentrated in selected indications and periods of competitor shortage. Sumycin generates no material standalone revenue.

Upside case

A manufacturer captures value through reliable supply, an approved alternative dosage form, a pediatric product, or a clinically differentiated reformulation. The value belongs to the new product and its regulatory approvals, not the legacy Sumycin brand.

Downside case

Generic competition intensifies, prescribers favor doxycycline or minocycline, and supply volatility reduces the attractiveness of tetracycline manufacturing. Prices remain compressed, and market participation becomes dependent on operational efficiency.

Key Takeaways

• Sumycin was a historical Bristol-Myers Squibb brand for tetracycline hydrochloride.
• The brand has no meaningful current exclusivity or patent-based market protection.
• Generic tetracycline competition is mature and established.
• Doxycycline and minocycline reduced Sumycin’s clinical and commercial relevance.
• No current material Orange Book patent, Paragraph IV dispute, or Sumycin-specific litigation position is apparent.
• Bristol-Myers Squibb does not publicly report standalone Sumycin revenue.
• Sumycin’s financial trajectory is one of long-term brand erosion followed by commercial discontinuation.
• Current value is concentrated in generic supply, manufacturing reliability, and potential differentiated reformulations.
• Biosimilar risk does not apply because tetracycline is a small-molecule antibiotic, not a biologic.
• A Sumycin relaunch without product differentiation would face immediate generic and therapeutic substitution.

FAQs

Is Sumycin still available by prescription?

The Sumycin brand is not a meaningful current U.S. commercial product. Tetracycline hydrochloride remains available through generic prescription products, subject to manufacturer and pharmacy inventory.

Is Sumycin the same as tetracycline?

Yes. Sumycin was a brand name associated with tetracycline hydrochloride. Generic tetracycline hydrochloride is the relevant current substitute.

Did Sumycin have a patent extension?

No current patent extension creates meaningful Sumycin exclusivity. Any original product protection expired long ago.

Can a company relaunch Sumycin?

A company could seek to commercialize a tetracycline product, but a relaunch would face generic competition and would require an approved regulatory pathway. The legacy brand alone would not provide market protection.

Does Sumycin have biosimilar competition?

No. Biosimilars apply to biological products. Sumycin is based on tetracycline hydrochloride, a chemically synthesized small molecule, so its competitors are generic drugs rather than biosimilars.

References

Bristol-Myers Squibb. (2000). Annual report 2000. https://www.annualreports.com/HostedData/AnnualReportArchive/b/NYSE_BMY_2000.pdf

Bristol-Myers Squibb. (2024). 2023 annual report. https://www.bms.com/investors/annual-reports.html

U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

U.S. Food and Drug Administration. (2024b). FDA drug database and discontinued drug products. https://www.fda.gov/drugs/drug-approvals-and-databases

U.S. National Library of Medicine. (2024). DailyMed: Tetracycline hydrochloride drug labels. https://dailymed.nlm.nih.gov/dailymed/